18 and older, female only, with Cancer of the Cervix or Cervical Neoplasms. 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 of Integrated Boost Radiation Therapy, Administered With IMRT Technique With Concurrent Chemotherapy (Cisplatin).Primary· During RT to 6 weeks post RT
Concurrent radiation therapy and chemotherapy is the standard of care for node positive cervical cancer. While there are several acceptable means to boost the disease in the low pelvis (i.e. brachytherapy, IMRT, or external beam), there is limited research into boosting gross disease in the pelvis or para-aortic region. This protocol is designed to determine the maximum tolerated dose of treating tumor bearing regions within the abdomen and pelvis, using an integrated boost technique and concurrent chemotherapy.
Group
Value
95% CI
Treatment Arm
70
Time to Local-regional Control With Integrated Boost Radiation Therapy (TTLR)Secondary· 3 years following treatment
Local-regional control is defined as local control without any nodal recurrence.
Group
Value
95% CI
Combined Treatment Arms
1.5
± 0.1
Boost Radiation: Dose Level 1 (60 Gy)
NA
± NA
Boost Radiation: Dose Level 2 (65)
0.65
± NA
Boost Radiation: Dose Level 3 (70Gy)
1.52
± 0.04
Time to Distant Recurrence (TTDR)Secondary· 3 years after treatment
Group
Value
95% CI
Combined Treatment Arms
1.4
± 0.1
Boost Radiation: Dose Level 1 (60 Gy)
NA
± NA
Boost Radiation: Dose Level 2 (65)
1.2
± NA
Boost Radiation: Dose Level 3 (70Gy)
1.29
± 0.22
Disease Free Survival (DFS)Secondary· 3 years after treatment
Group
Value
95% CI
Combined Treatment Arms
1.3
± 0.1
Boost Radiation: Dose Level 1 (60 Gy)
0.85
± NA
Boost Radiation: Dose Level 2 (65)
1.05
± 0.23
Boost Radiation: Dose Level 3 (70Gy)
1.34
± 0.2
Overall Survival (OS)Secondary· 3 years after treatment
Group
Value
95% CI
Combined Treatment Arms
1.6
± 0.1
Boost Radiation: Dose Level 1 (60 Gy)
0.85
± NA
Boost Radiation: Dose Level 2 (65)
1.08
± NA
Boost Radiation: Dose Level 3 (70Gy)
1.7
± NA
Number of Participants With Acute Dose Limiting Toxicities (DLT)Secondary· 6 weeks following treatment
Acute DLT will be defined based on the side effects inherent from radiation therapy for gynecologic cancers, including effects on bowel, bladder, and skin.Since integrated radiation dose escalation is unlikely to substantially affect the hematopoietic system, only non-hematologic, grade 3-4, acute toxicity will be considered the primary dose-limiting toxicity (acute DLT). Dose limiting toxicity will include any of the following during treatment or within 6 weeks of completion: Acute Grade 3-4 enteritis or proctitis, Acute Grade 3-4 bladder toxicity, Acute Grade 4 dermatologic toxicity.
Group
Value
95% CI
Combined Treatment Arms
1
Boost Radiation: Dose Level 1 (60 Gy)
0
Boost Radiation: Dose Level 2 (65)
0
Boost Radiation: Dose Level 3 (70Gy)
1
Number of Participants With Late Dose Limiting Toxicities (DLT)Secondary· 3 years following treatment
Late DLTs will be defined at grade 3-4 GI or GU toxicity with onset after 6 weeks of treatment.
Group
Value
95% CI
Combined Treatment Arms
1
Boost Radiation: Dose Level 1 (60 Gy)
0
Boost Radiation: Dose Level 2 (65)
0
Boost Radiation: Dose Level 3 (70Gy)
1
Adverse events — posted to ClinicalTrials.gov
Time frame: 3 years.
Reporting threshold: 0%.
Adverse-event reports describe events observed during the trial — not all are caused by the drug.
The purpose of this study is to determine the maximum tolerated dose of integrated boost radiation therapy when given with concurrent chemotherapy (cisplatin).
Publications & conference data
No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Duke University
Last refreshed: 8 February 2021
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/NCT01627288.