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Home › Trials › NCT04827732 NCT04827732: IMPARC
Hypofractionated Pencil-Beam Scanning Intensity-modulated Proton Therapy (IMPT) in Recurrent Rectal Cancer
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Summary Quick facts Who can join Endpoints Results Adverse events Publications Related trials Sources
Terminated
NA
Results posted
Last updated 29 September 2025
What this trial tests
NA trial testing Hypofractionated Pencil-Beam Scanning Intensity-modulated Proton Therapy in Recurrent Rectal Cancer in 15 participants. Terminated before completion.
Timeline
4 May 2021
Primary endpoint
18 November 2024
Quick facts
Lead sponsor Washington University School of Medicine Phase NA Status Terminated Study type INTERVENTIONAL Allocation non randomized Design sequential Masking none Primary purpose treatment Enrollment 15 Start date 4 May 2021 Primary completion 29 July 2024 Estimated completion 18 November 2024 Sites 1 location across United States
Drugs / interventions tested
Hypofractionated Pencil-Beam Scanning Intensity-modulated Proton Therapy MEVION S250i Hyperscan and Adaptive Aperture Proton Therapy Machine
Conditions studied
Sponsor
Washington University School of Medicine
Who can join
18 and older, any sex, with Recurrent Rectal Cancer. Patients with the condition only — healthy volunteers not accepted.
Results — posted to ClinicalTrials.gov
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
Maximum Tolerated Dose (MTD) of Reirradiation Using Hypofractionated IMPT
Primary
· From start of treatment through 6 months
* MTD is defined as the dose associated with a 35% probability of dose-limiting toxicity (DLT).
* DLT is defined as any toxicity listed below that occurs within 6 months from start of treatment and is considered possibly, probably, or definitely related to proton reirradiation:
* Any grade 5 toxicities
* Any grade 4-5 GI toxicities
* Bowel obstruction
* Grade 3-5: diarrhea; anal, colonic, or bowel ulcers; bladder perforation; any fistula formations; peripheral motor/sensory neuropathy of the pelvis above baseline; osteonecrosis/soft tissue necrosis; radiation dermatitis; hematuria; he
Group Value 95% CI All Dose Levels: Hypofractionated Pencil-Beam Scanning Intensity-modulated Proton Therapy (IMPT) 40
Clinical Complete Response Rate
Secondary
· Within 6 weeks to 3 months post-completion of radiation therapy (range 7-14 weeks)
-DRE, endoscopy, and cross-sectional imaging will be used to measure clinical complete response rate
Group Value 95% CI Dose Level 1: Hypofractionated Pencil-Beam Scanning Intensity-modulated Proton Therapy (IMPT) 0 Dose Level 2: Hypofractionated Pencil-Beam Scanning Intensity-modulated Proton Therapy (IMPT) 0 Dose Level 3: Hypofractionated Pencil-Beam Scanning Intensity-modulated Proton Therapy (IMPT) 0
Median Freedom From Locoregional Progression (FFLP)
Secondary
· Through completion of follow-up (full range 1.81 months-13.87 months)
-Defined as time from end of radiation therapy to date of first instance of local or regional tumor progression
Group Value 95% CI Dose Level 1: Hypofractionated Pencil-Beam Scanning Intensity-modulated Proton Therapy (IMPT) 7.53 1.81 – 13.87 Dose Level 2: Hypofractionated Pencil-Beam Scanning Intensity-modulated Proton Therapy (IMPT) 9.53 2.01 – 10.72 Dose Level 3: Hypofractionated Pencil-Beam Scanning Intensity-modulated Proton Therapy (IMPT) 4.37 4.01 – 12.72
Median Overall Survival (OS)
Secondary
· Through completion of follow-up (full range 4.4 months to 13.87 months)
Defined as time from end of radiation therapy to date that at least 50% of patients died
Group Value 95% CI Dose Level 1: Hypofractionated Pencil-Beam Scanning Intensity-modulated Proton Therapy (IMPT) NA 6.4 – 13.87 Dose Level 2: Hypofractionated Pencil-Beam Scanning Intensity-modulated Proton Therapy (IMPT) 9.53 8.58 – 10.72 Dose Level 3: Hypofractionated Pencil-Beam Scanning Intensity-modulated Proton Therapy (IMPT) NA 4.4 – 12.72
Median Progression-free Survival (PFS)
Secondary
· Through completion of follow-up (full range 1.81 months-13.87 months)
-Defined as time from end of radiation therapy to the earliest date of locoregional progression, distant progression, or death from any cause
Group Value 95% CI Dose Level 1: Hypofractionated Pencil-Beam Scanning Intensity-modulated Proton Therapy (IMPT) 2.04 1.32 – 13.87 Dose Level 2: Hypofractionated Pencil-Beam Scanning Intensity-modulated Proton Therapy (IMPT) 9.53 2.01 – 10.72 Dose Level 3: Hypofractionated Pencil-Beam Scanning Intensity-modulated Proton Therapy (IMPT) 4.37 4.01 – 12.72
Median Change in Quality of Life (QoL) Score as Measured by The European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30)
Secondary
· Assessed at pre-treatment (baseline), 1-2 weeks, 3 months, 6 months, 9 months, and 12 months post-treatment
30 question survey which assesses patient well-being with 5 functional scales, 9 symptom scales, \& global health scale. Scores for each scale range from 0-100. Higher score for the functional scale \& global health represent high functioning, while high score for symptom scale represents high symptomatology. Median scores were taken for each scale for each dose level and the different between pre-treatment and post-treatment scores were calculated to determine change in score over time. For functional scales and global health status, negative values represent improved functionality/quality of
Global health status
Group Value 95% CI Dose Level 1: Hypofractionated Pencil-Beam Scanning Intensity-modulated Proton Therapy (IMPT) -4.17 -25 – 16.67 Dose Level 2: Hypofractionated Pencil-Beam Scanning Intensity-modulated Proton Therapy (IMPT) 0 -33.3 – 16.67 Dose Level 3: Hypofractionated Pencil-Beam Scanning Intensity-modulated Proton Therapy (IMPT) 8.34 8.34 – 8.34
Physical functioning
Group Value 95% CI Dose Level 1: Hypofractionated Pencil-Beam Scanning Intensity-modulated Proton Therapy (IMPT) 0 0 – 0 Dose Level 2: Hypofractionated Pencil-Beam Scanning Intensity-modulated Proton Therapy (IMPT) 6.67 0 – 13.33 Dose Level 3: Hypofractionated Pencil-Beam Scanning Intensity-modulated Proton Therapy (IMPT) -6.67 -6.67 – -6.67
Role functioning
Group Value 95% CI Dose Level 1: Hypofractionated Pencil-Beam Scanning Intensity-modulated Proton Therapy (IMPT) 0 0 – 0 Dose Level 2: Hypofractionated Pencil-Beam Scanning Intensity-modulated Proton Therapy (IMPT) 0 0 – 0 Dose Level 3: Hypofractionated Pencil-Beam Scanning Intensity-modulated Proton Therapy (IMPT) -16.67 -16.67 – -16.67
Emotional functioning
Group Value 95% CI Dose Level 1: Hypofractionated Pencil-Beam Scanning Intensity-modulated Proton Therapy (IMPT) -6.67 -20 – 0 Dose Level 2: Hypofractionated Pencil-Beam Scanning Intensity-modulated Proton Therapy (IMPT) 0 -33.33 – 6.67 Dose Level 3: Hypofractionated Pencil-Beam Scanning Intensity-modulated Proton Therapy (IMPT) 6.67 6.67 – 6.67
Cognitive functioning
Group Value 95% CI Dose Level 1: Hypofractionated Pencil-Beam Scanning Intensity-modulated Proton Therapy (IMPT) -8.33 -16.67 – 0 Dose Level 2: Hypofractionated Pencil-Beam Scanning Intensity-modulated Proton Therapy (IMPT) 0 -33.3 – 16.67 Dose Level 3: Hypofractionated Pencil-Beam Scanning Intensity-modulated Proton Therapy (IMPT) -16.67 -16.67 – -16.67
Social functioning
Group Value 95% CI Dose Level 1: Hypofractionated Pencil-Beam Scanning Intensity-modulated Proton Therapy (IMPT) 8.33 0 – 50 Dose Level 2: Hypofractionated Pencil-Beam Scanning Intensity-modulated Proton Therapy (IMPT) 0 0 – 0 Dose Level 3: Hypofractionated Pencil-Beam Scanning Intensity-modulated Proton Therapy (IMPT) -33.33 -33.33 – -33.33
Fatigue
Group Value 95% CI Dose Level 1: Hypofractionated Pencil-Beam Scanning Intensity-modulated Proton Therapy (IMPT) 0 -22.2 – 0 Dose Level 2: Hypofractionated Pencil-Beam Scanning Intensity-modulated Proton Therapy (IMPT) 0 -11.11 – 22.22 Dose Level 3: Hypofractionated Pencil-Beam Scanning Intensity-modulated Proton Therapy (IMPT) 0 0 – 0
Nausea and vomiting
Group Value 95% CI Dose Level 1: Hypofractionated Pencil-Beam Scanning Intensity-modulated Proton Therapy (IMPT) 0 0 – 0 Dose Level 2: Hypofractionated Pencil-Beam Scanning Intensity-modulated Proton Therapy (IMPT) 0 -16.67 – 0 Dose Level 3: Hypofractionated Pencil-Beam Scanning Intensity-modulated Proton Therapy (IMPT) 16.67 16.67 – 16.67
Median Change in Quality of Life (QoL) Score as Measured by The European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30)
Secondary
· Assessed at pre-treatment (baseline), 1-2 weeks, 3 months, 6 months, 9 months, and 12 months post-treatment
30 question survey which assesses patient well-being with 5 functional scales, 9 symptom scales, \& global health scale. Scores for each scale range from 0-100. Higher score for the functional scale \& global health represent high functioning, while high score for symptom scale represents high symptomatology. Median scores were taken for each scale for each dose level and the different between pre-treatment and post-treatment scores were calculated to determine change in score over time. For functional scales and global health status, negative values represent improved functionality/quality of
Global health status
Group Value 95% CI Dose Level 1: Hypofractionated Pencil-Beam Scanning Intensity-modulated Proton Therapy (IMPT) 8.33 0 – 54.17 Dose Level 2: Hypofractionated Pencil-Beam Scanning Intensity-modulated Proton Therapy (IMPT) 0 -22.22 – 0 Dose Level 3: Hypofractionated Pencil-Beam Scanning Intensity-modulated Proton Therapy (IMPT) 8.33 8.33 – 8.33
Physical functioning
Group Value 95% CI Dose Level 1: Hypofractionated Pencil-Beam Scanning Intensity-modulated Proton Therapy (IMPT) 3.33 0 – 26.67 Dose Level 2: Hypofractionated Pencil-Beam Scanning Intensity-modulated Proton Therapy (IMPT) 2.22 0 – 3.33 Dose Level 3: Hypofractionated Pencil-Beam Scanning Intensity-modulated Proton Therapy (IMPT) 0 0 – 0
Role functioning
Group Value 95% CI Dose Level 1: Hypofractionated Pencil-Beam Scanning Intensity-modulated Proton Therapy (IMPT) 16.67 0 – 58.33 Dose Level 2: Hypofractionated Pencil-Beam Scanning Intensity-modulated Proton Therapy (IMPT) 11.11 0 – 33.33 Dose Level 3: Hypofractionated Pencil-Beam Scanning Intensity-modulated Proton Therapy (IMPT) 0 0 – 0
Emotional functioning
Group Value 95% CI Dose Level 1: Hypofractionated Pencil-Beam Scanning Intensity-modulated Proton Therapy (IMPT) -3.33 -16.67 – 20 Dose Level 2: Hypofractionated Pencil-Beam Scanning Intensity-modulated Proton Therapy (IMPT) -2.22 -10 – 0 Dose Level 3: Hypofractionated Pencil-Beam Scanning Intensity-modulated Proton Therapy (IMPT) -10 -10 – -10
Cognitive functioning
Group Value 95% CI Dose Level 1: Hypofractionated Pencil-Beam Scanning Intensity-modulated Proton Therapy (IMPT) 0 -16.67 – 8.33 Dose Level 2: Hypofractionated Pencil-Beam Scanning Intensity-modulated Proton Therapy (IMPT) -8.33 -16.67 – 0 Dose Level 3: Hypofractionated Pencil-Beam Scanning Intensity-modulated Proton Therapy (IMPT) -8.34 -8.34 – -8.34
Social functioning
Group Value 95% CI Dose Level 1: Hypofractionated Pencil-Beam Scanning Intensity-modulated Proton Therapy (IMPT) 8.33 0 – 16.67 Dose Level 2: Hypofractionated Pencil-Beam Scanning Intensity-modulated Proton Therapy (IMPT) 5.56 0 – 16.67 Dose Level 3: Hypofractionated Pencil-Beam Scanning Intensity-modulated Proton Therapy (IMPT) -25 -25 – -25
Fatigue
Group Value 95% CI Dose Level 1: Hypofractionated Pencil-Beam Scanning Intensity-modulated Proton Therapy (IMPT) -19.44 -61.11 – -5.56 Dose Level 2: Hypofractionated Pencil-Beam Scanning Intensity-modulated Proton Therapy (IMPT) 5.56 0 – 25.93 Dose Level 3: Hypofractionated Pencil-Beam Scanning Intensity-modulated Proton Therapy (IMPT) 0 0 – 0
Nausea and vomiting
Group Value 95% CI Dose Level 1: Hypofractionated Pencil-Beam Scanning Intensity-modulated Proton Therapy (IMPT) 0 -8.33 – 0 Dose Level 2: Hypofractionated Pencil-Beam Scanning Intensity-modulated Proton Therapy (IMPT) 0 -5.56 – 8.33 Dose Level 3: Hypofractionated Pencil-Beam Scanning Intensity-modulated Proton Therapy (IMPT) -8.33 -8.33 – -8.33
Median Change in Quality of Life (QoL) Score as Measured by the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire Colorectal Cancer Module 29 (EORTC QLQ-CR29)
Secondary
· Assessed at pre-treatment (baseline), 1-2 weeks, 3 months, 6 months, 9 months, and 12 months post-treatment
29 question survey which assesses quality of life for patients with colorectal cancer including functional \& symptom status. The survey includes 4 multi-item scales \& 19 single-item scales. Scores are linearly transformed to provide a score from 0-100. A high score for functional scales represents high level of functioning, while a high score for symptom scale represents high level of symptoms. Median scores were taken for each scale \& the difference between baseline \& varying time points was reported. Negative value represents improved function for a functional scale item, \& worsening sy
Anxiety
Group Value 95% CI Dose Level 1: Hypofractionated Pencil-Beam Scanning Intensity-modulated Proton Therapy (IMPT) 0 -33.33 – 33.33 Dose Level 2: Hypofractionated Pencil-Beam Scanning Intensity-modulated Proton Therapy (IMPT) 0 0 – 0 Dose Level 3: Hypofractionated Pencil-Beam Scanning Intensity-modulated Proton Therapy (IMPT) -33.34 -33.34 – -33.34
Body image
Group Value 95% CI Dose Level 1: Hypofractionated Pencil-Beam Scanning Intensity-modulated Proton Therapy (IMPT) -12.5 -25 – 0 Dose Level 2: Hypofractionated Pencil-Beam Scanning Intensity-modulated Proton Therapy (IMPT) 8.33 -16.67 – 8.33 Dose Level 3: Hypofractionated Pencil-Beam Scanning Intensity-modulated Proton Therapy (IMPT) 8.34 8.34 – 8.34
Male sexual function
Group Value 95% CI Dose Level 1: Hypofractionated Pencil-Beam Scanning Intensity-modulated Proton Therapy (IMPT) 0 -66.67 – 66.67 Dose Level 2: Hypofractionated Pencil-Beam Scanning Intensity-modulated Proton Therapy (IMPT) -16.67 -33.33 – 0
Female sexual function
Group Value 95% CI Dose Level 1: Hypofractionated Pencil-Beam Scanning Intensity-modulated Proton Therapy (IMPT) 0 0 – 0 Dose Level 2: Hypofractionated Pencil-Beam Scanning Intensity-modulated Proton Therapy (IMPT) 0 0 – 0 Dose Level 3: Hypofractionated Pencil-Beam Scanning Intensity-modulated Proton Therapy (IMPT) -33.33 -33.33 – -33.33
Micturition
Group Value 95% CI Dose Level 1: Hypofractionated Pencil-Beam Scanning Intensity-modulated Proton Therapy (IMPT) 4.17 -8.33 – 8.33 Dose Level 2: Hypofractionated Pencil-Beam Scanning Intensity-modulated Proton Therapy (IMPT) -8.33 -25 – 0 Dose Level 3: Hypofractionated Pencil-Beam Scanning Intensity-modulated Proton Therapy (IMPT) 8.33 8.33 – 8.33
Abdominal and pelvic pain
Group Value 95% CI Dose Level 1: Hypofractionated Pencil-Beam Scanning Intensity-modulated Proton Therapy (IMPT) 0 0 – 16.67 Dose Level 2: Hypofractionated Pencil-Beam Scanning Intensity-modulated Proton Therapy (IMPT) -16.67 -33.33 – 33.33 Dose Level 3: Hypofractionated Pencil-Beam Scanning Intensity-modulated Proton Therapy (IMPT) 0 0 – 0
Bloated feeling
Group Value 95% CI Dose Level 1: Hypofractionated Pencil-Beam Scanning Intensity-modulated Proton Therapy (IMPT) 0 0 – 0 Dose Level 2: Hypofractionated Pencil-Beam Scanning Intensity-modulated Proton Therapy (IMPT) 0 0 – -3.33 Dose Level 3: Hypofractionated Pencil-Beam Scanning Intensity-modulated Proton Therapy (IMPT) 0 0 – 0
Dry mouth
Group Value 95% CI Dose Level 1: Hypofractionated Pencil-Beam Scanning Intensity-modulated Proton Therapy (IMPT) 0 0 – 3.33 Dose Level 2: Hypofractionated Pencil-Beam Scanning Intensity-modulated Proton Therapy (IMPT) 0 -33.33 – 33.33 Dose Level 3: Hypofractionated Pencil-Beam Scanning Intensity-modulated Proton Therapy (IMPT) -33.34 -33.34 – -33.34
Median Change in Quality of Life (QoL) Score as Measured by the by the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire Colorectal Cancer Module 29 (EORTC QLQ-CR29)
Secondary
· Assessed at pre-treatment (baseline), 1-2 weeks, 3 months, 6 months, 9 months, and 12 months post-treatment
29 question survey which assesses quality of life for patients with colorectal cancer including functional \& symptom status. The survey includes 4 multi-item scales \& 19 single-item scales. Scores are linearly transformed to provide a score from 0-100. A high score for functional scales represents high level of functioning, while a high score for symptom scale represents high level of symptoms. Median scores were taken for each scale \& the difference between baseline \& varying time points was reported. Negative value represents improved function for a functional scale item, \& worsening sy
Anxiety
Group Value 95% CI Dose Level 1: Hypofractionated Pencil-Beam Scanning Intensity-modulated Proton Therapy (IMPT) 8.33 -8.33 – 16.67 Dose Level 2: Hypofractionated Pencil-Beam Scanning Intensity-modulated Proton Therapy (IMPT) 0 0 – 0 Dose Level 3: Hypofractionated Pencil-Beam Scanning Intensity-modulated Proton Therapy (IMPT) -16.67 -16.67 – -16.67
Body image
Group Value 95% CI Dose Level 1: Hypofractionated Pencil-Beam Scanning Intensity-modulated Proton Therapy (IMPT) 1.04 -16.67 – 20.83 Dose Level 2: Hypofractionated Pencil-Beam Scanning Intensity-modulated Proton Therapy (IMPT) -8.33 -22.22 – 8.33 Dose Level 3: Hypofractionated Pencil-Beam Scanning Intensity-modulated Proton Therapy (IMPT) 4.17 4.17 – 4.17
Male sexual function
Group Value 95% CI Dose Level 1: Hypofractionated Pencil-Beam Scanning Intensity-modulated Proton Therapy (IMPT) 0 0 – 0 Dose Level 2: Hypofractionated Pencil-Beam Scanning Intensity-modulated Proton Therapy (IMPT) -16.67 -33.33 – 0
Female sexual function
Group Value 95% CI Dose Level 1: Hypofractionated Pencil-Beam Scanning Intensity-modulated Proton Therapy (IMPT) 8.34 8.34 – 8.34 Dose Level 2: Hypofractionated Pencil-Beam Scanning Intensity-modulated Proton Therapy (IMPT) 0 0 – 0 Dose Level 3: Hypofractionated Pencil-Beam Scanning Intensity-modulated Proton Therapy (IMPT) -33.33 -33.33 – -33.33
Micturition
Group Value 95% CI Dose Level 1: Hypofractionated Pencil-Beam Scanning Intensity-modulated Proton Therapy (IMPT) 0 -12.5 – 8.33 Dose Level 2: Hypofractionated Pencil-Beam Scanning Intensity-modulated Proton Therapy (IMPT) -19.44 -41.67 – 16.67 Dose Level 3: Hypofractionated Pencil-Beam Scanning Intensity-modulated Proton Therapy (IMPT) 4.16 4.16 – 4.16
Abdominal and pelvic pain
Group Value 95% CI Dose Level 1: Hypofractionated Pencil-Beam Scanning Intensity-modulated Proton Therapy (IMPT) -8.33 -75 – 0 Dose Level 2: Hypofractionated Pencil-Beam Scanning Intensity-modulated Proton Therapy (IMPT) 0 0 – 22.22 Dose Level 3: Hypofractionated Pencil-Beam Scanning Intensity-modulated Proton Therapy (IMPT) -8.33 -8.33 – -8.33
Bloated feeling
Group Value 95% CI Dose Level 1: Hypofractionated Pencil-Beam Scanning Intensity-modulated Proton Therapy (IMPT) 0 -33.33 – 0 Dose Level 2: Hypofractionated Pencil-Beam Scanning Intensity-modulated Proton Therapy (IMPT) 0 -33.33 – 0 Dose Level 3: Hypofractionated Pencil-Beam Scanning Intensity-modulated Proton Therapy (IMPT) 0 0 – 0
Dry mouth
Group Value 95% CI Dose Level 1: Hypofractionated Pencil-Beam Scanning Intensity-modulated Proton Therapy (IMPT) 0 -33.33 – 33.33 Dose Level 2: Hypofractionated Pencil-Beam Scanning Intensity-modulated Proton Therapy (IMPT) 0 -16.67 – 0 Dose Level 3: Hypofractionated Pencil-Beam Scanning Intensity-modulated Proton Therapy (IMPT) 16.66 16.66 – 16.66
Frequency of Treatment-related Acute Adverse Events as Measured by CTCAE v 5.0
Secondary
· From start of treatment through 3 months after completion of radiation therapy (estimated to be 3 months and 1 week)
Fatigue
Group Value 95% CI Dose Level 1: Hypofractionated Pencil-Beam Scanning Intensity-modulated Proton Therapy (IMPT) 1 Dose Level 2: Hypofractionated Pencil-Beam Scanning Intensity-modulated Proton Therapy (IMPT) 1 Dose Level 3: Hypofractionated Pencil-Beam Scanning Intensity-modulated Proton Therapy (IMPT) 2 Dose Level -1: Hypofractionated Pencil-Beam Scanning Intensity-modulated Proton Therapy (IMPT) 0
Dyspareunia
Group Value 95% CI Dose Level 1: Hypofractionated Pencil-Beam Scanning Intensity-modulated Proton Therapy (IMPT) 1 Dose Level 2: Hypofractionated Pencil-Beam Scanning Intensity-modulated Proton Therapy (IMPT) 0 Dose Level 3: Hypofractionated Pencil-Beam Scanning Intensity-modulated Proton Therapy (IMPT) 0 Dose Level -1: Hypofractionated Pencil-Beam Scanning Intensity-modulated Proton Therapy (IMPT) 0
Pelvic pressure
Group Value 95% CI Dose Level 1: Hypofractionated Pencil-Beam Scanning Intensity-modulated Proton Therapy (IMPT) 0 Dose Level 2: Hypofractionated Pencil-Beam Scanning Intensity-modulated Proton Therapy (IMPT) 1 Dose Level 3: Hypofractionated Pencil-Beam Scanning Intensity-modulated Proton Therapy (IMPT) 0 Dose Level -1: Hypofractionated Pencil-Beam Scanning Intensity-modulated Proton Therapy (IMPT) 0
Vaginal dryness
Group Value 95% CI Dose Level 1: Hypofractionated Pencil-Beam Scanning Intensity-modulated Proton Therapy (IMPT) 1 Dose Level 2: Hypofractionated Pencil-Beam Scanning Intensity-modulated Proton Therapy (IMPT) 0 Dose Level 3: Hypofractionated Pencil-Beam Scanning Intensity-modulated Proton Therapy (IMPT) 0 Dose Level -1: Hypofractionated Pencil-Beam Scanning Intensity-modulated Proton Therapy (IMPT) 0
Erectile dysfunction
Group Value 95% CI Dose Level 1: Hypofractionated Pencil-Beam Scanning Intensity-modulated Proton Therapy (IMPT) 1 Dose Level 2: Hypofractionated Pencil-Beam Scanning Intensity-modulated Proton Therapy (IMPT) 0 Dose Level 3: Hypofractionated Pencil-Beam Scanning Intensity-modulated Proton Therapy (IMPT) 0 Dose Level -1: Hypofractionated Pencil-Beam Scanning Intensity-modulated Proton Therapy (IMPT) 0
Scrotal pain
Group Value 95% CI Dose Level 1: Hypofractionated Pencil-Beam Scanning Intensity-modulated Proton Therapy (IMPT) 0 Dose Level 2: Hypofractionated Pencil-Beam Scanning Intensity-modulated Proton Therapy (IMPT) 1 Dose Level 3: Hypofractionated Pencil-Beam Scanning Intensity-modulated Proton Therapy (IMPT) 0 Dose Level -1: Hypofractionated Pencil-Beam Scanning Intensity-modulated Proton Therapy (IMPT) 0
Urinary urgency
Group Value 95% CI Dose Level 1: Hypofractionated Pencil-Beam Scanning Intensity-modulated Proton Therapy (IMPT) 2 Dose Level 2: Hypofractionated Pencil-Beam Scanning Intensity-modulated Proton Therapy (IMPT) 0 Dose Level 3: Hypofractionated Pencil-Beam Scanning Intensity-modulated Proton Therapy (IMPT) 0 Dose Level -1: Hypofractionated Pencil-Beam Scanning Intensity-modulated Proton Therapy (IMPT) 0
Urinary retention
Group Value 95% CI Dose Level 1: Hypofractionated Pencil-Beam Scanning Intensity-modulated Proton Therapy (IMPT) 1 Dose Level 2: Hypofractionated Pencil-Beam Scanning Intensity-modulated Proton Therapy (IMPT) 0 Dose Level 3: Hypofractionated Pencil-Beam Scanning Intensity-modulated Proton Therapy (IMPT) 0 Dose Level -1: Hypofractionated Pencil-Beam Scanning Intensity-modulated Proton Therapy (IMPT) 0
Frequency of Treatment-related Late Adverse Events as Measured by CTCAE v 5.0
Secondary
· From 3 month post-completion of radiation therapy to 12 months post-completion of radiation therapy
Anemia
Group Value 95% CI Dose Level 1: Hypofractionated Pencil-Beam Scanning Intensity-modulated Proton Therapy (IMPT) 1 Dose Level 2: Hypofractionated Pencil-Beam Scanning Intensity-modulated Proton Therapy (IMPT) 0 Dose Level 3: Hypofractionated Pencil-Beam Scanning Intensity-modulated Proton Therapy (IMPT) 0
Fatigue
Group Value 95% CI Dose Level 1: Hypofractionated Pencil-Beam Scanning Intensity-modulated Proton Therapy (IMPT) 1 Dose Level 2: Hypofractionated Pencil-Beam Scanning Intensity-modulated Proton Therapy (IMPT) 0 Dose Level 3: Hypofractionated Pencil-Beam Scanning Intensity-modulated Proton Therapy (IMPT) 1
Urinary tract obstruction
Group Value 95% CI Dose Level 1: Hypofractionated Pencil-Beam Scanning Intensity-modulated Proton Therapy (IMPT) 0 Dose Level 2: Hypofractionated Pencil-Beam Scanning Intensity-modulated Proton Therapy (IMPT) 1 Dose Level 3: Hypofractionated Pencil-Beam Scanning Intensity-modulated Proton Therapy (IMPT) 0
Urinary incontinence
Group Value 95% CI Dose Level 1: Hypofractionated Pencil-Beam Scanning Intensity-modulated Proton Therapy (IMPT) 0 Dose Level 2: Hypofractionated Pencil-Beam Scanning Intensity-modulated Proton Therapy (IMPT) 1 Dose Level 3: Hypofractionated Pencil-Beam Scanning Intensity-modulated Proton Therapy (IMPT) 0
Nausea
Group Value 95% CI Dose Level 1: Hypofractionated Pencil-Beam Scanning Intensity-modulated Proton Therapy (IMPT) 1 Dose Level 2: Hypofractionated Pencil-Beam Scanning Intensity-modulated Proton Therapy (IMPT) 0 Dose Level 3: Hypofractionated Pencil-Beam Scanning Intensity-modulated Proton Therapy (IMPT) 0
Abdominal pain
Group Value 95% CI Dose Level 1: Hypofractionated Pencil-Beam Scanning Intensity-modulated Proton Therapy (IMPT) 1 Dose Level 2: Hypofractionated Pencil-Beam Scanning Intensity-modulated Proton Therapy (IMPT) 0 Dose Level 3: Hypofractionated Pencil-Beam Scanning Intensity-modulated Proton Therapy (IMPT) 1
Constipation
Group Value 95% CI Dose Level 1: Hypofractionated Pencil-Beam Scanning Intensity-modulated Proton Therapy (IMPT) 1 Dose Level 2: Hypofractionated Pencil-Beam Scanning Intensity-modulated Proton Therapy (IMPT) 0 Dose Level 3: Hypofractionated Pencil-Beam Scanning Intensity-modulated Proton Therapy (IMPT) 0
Rectal pain
Group Value 95% CI Dose Level 1: Hypofractionated Pencil-Beam Scanning Intensity-modulated Proton Therapy (IMPT) 1 Dose Level 2: Hypofractionated Pencil-Beam Scanning Intensity-modulated Proton Therapy (IMPT) 0 Dose Level 3: Hypofractionated Pencil-Beam Scanning Intensity-modulated Proton Therapy (IMPT) 0
Adverse events — posted to ClinicalTrials.gov
Time frame: All-cause mortality was collected through completion of follow-up (full range 4.4 months through 13.87 months). Adverse events were collected from start of treatment through 12 months after completion of radiation therapy..
Reporting threshold: 0%.
Adverse-event reports describe events observed during the trial — not all are caused by the drug.
Dose Level -1: Hypofractionated Pencil-Beam Scanning Intensity-modulated Proton Therapy (IMPT)
Serious: 1/1 (100%)
Deaths: 0/1
Dose Level 1: Hypofractionated Pencil-Beam Scanning Intensity-modulated Proton Therapy (IMPT)
Serious: 4/6 (67%)
Deaths: 2/6
Dose Level 2: Hypofractionated Pencil-Beam Scanning Intensity-modulated Proton Therapy (IMPT)
Serious: 2/3 (67%)
Deaths: 2/3
Dose Level 3: Hypofractionated Pencil-Beam Scanning Intensity-modulated Proton Therapy (IMPT)
Serious: 1/3 (33%)
Deaths: 1/3
Serious adverse events (12 terms) Reaction System Dose Level -1: Hypofractio… Dose Level 1: Hypofraction… Dose Level 2: Hypofraction… Dose Level 3: Hypofraction… Death due to disease progression Neoplasms benign, malignant and unspecified (incl cysts and polyps) — — — — Abdominal pain Gastrointestinal disorders — — — — Ischemic bowel Gastrointestinal disorders — — — — Rectal perforation Gastrointestinal disorders — — — — Small intestinal obstruction Gastrointestinal disorders — — — — Redness and drainage around buttocks wound General disorders — — — — Cholecystitis Hepatobiliary disorders — — — — Chronic abscess Infections and infestations — — — — Pelvic infection Infections and infestations — — — — Sepsis Infections and infestations — — — — Pelvic abscess (complication from surgery) Injury, poisoning and procedural complications — — — — Urinary tract obstruction Renal and urinary disorders — — — —
Other adverse events (82 terms — click to expand) Reaction System Dose Level -1: Hypofractio… Dose Level 1: Hypofraction… Dose Level 2: Hypofraction… Dose Level 3: Hypofraction… Pain General disorders — — — — Diarrhea Gastrointestinal disorders — — — — Urinary urgency Renal and urinary disorders — — — — Abdominal pain Gastrointestinal disorders — — — — Nausea Gastrointestinal disorders — — — — Vomiting Gastrointestinal disorders — — — — Cold sensitivity General disorders — — — — Fatigue General disorders — — — — Generalized muscle weakness Musculoskeletal and connective tissue disorders — — — — Peripheral sensory neuropathy Nervous system disorders — — — — Urinary frequency Renal and urinary disorders — — — — Urinary retention Renal and urinary disorders — — — — Dyspnea Respiratory, thoracic and mediastinal disorders — — — — Anemia Blood and lymphatic system disorders — — — — Supraventricular tachycardia Cardiac disorders — — — — Tachycardia Cardiac disorders — — — — Scleral disorder Eye disorders — — — — Abdominal distension Gastrointestinal disorders — — — — Anal fissure Gastrointestinal disorders — — — — Constipation Gastrointestinal disorders — — — — Dry mouth Gastrointestinal disorders — — — — Flatulence Gastrointestinal disorders — — — — Full feeling Gastrointestinal disorders — — — — Gastric hemorrhage Gastrointestinal disorders — — — — Mouth sore Gastrointestinal disorders — — — — Rectal bleeding Gastrointestinal disorders — — — — Rectal fistula Gastrointestinal disorders — — — — Rectal frequency and urgency Gastrointestinal disorders — — — — Rectal pain Gastrointestinal disorders — — — — Stool leakage Gastrointestinal disorders — — — — Chills General disorders — — — — Fever General disorders — — — — Non-cardiac chest pain General disorders — — — — COVID-19 infection Infections and infestations — — — — Mass or abscess with leaking Infections and infestations — — — — Urinary tract infection Infections and infestations — — — — Bruising Injury, poisoning and procedural complications — — — — Fall Injury, poisoning and procedural complications — — — — Blood lactacte dehydrogenase increased Investigations — — — — Neutrophil count decreased Investigations — — — —
Most-reported serious reactions: Death due to disease progression , Abdominal pain , Ischemic bowel , Rectal perforation , Small intestinal obstruction , Redness and drainage around buttocks wound , Cholecystitis , Chronic abscess .
Data from ClinicalTrials.gov NCT04827732 adverse events section .
Sponsor's own description
The purpose of this trial is to determine the maximum tolerated dose (MTD) of hypofractionated IMPT for the reirradiation of locoregionally recurrent rectal cancer.
Publications & conference data
2 peer-reviewed publications reference this trial (live from Europe PMC):
PTCOG Gastrointestinal Subcommittee Lower Gastrointestinal Tract Malignancies Consensus Statement.
Isabelle Choi J, Wojcieszynski A, Amos RA, Giap H, et al ·
· 2024
· cited 3×
· PMID 38757077
· DOI 10.1016/j.ijpt.2024.100019
Acute toxicity and quality of life in dose-escalated proton reirradiation for locally recurrent rectal cancer: The prospective ReRad II trial.
Truelsen CG, Rønde HS, Kallehauge JF, Szpejewska JE, et al ·
· 2025
· PMID 40677620
· DOI 10.1016/j.ctro.2025.100999
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Verify against primary sources
Data sources for this page
Trial protocol + status : ClinicalTrials.gov NCT04827732 (US National Library of Medicine, public domain)Publications : Europe PMC API search by NCT ID, retrieved 10 June 2026Drug + disease cross-links : matched in real time against Drug Landscape's normalised drug + company + condition tablesSponsor : as reported to ClinicalTrials.gov by Washington University School of MedicineLast refreshed : 29 September 2025
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT04827732.
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