NCT01819831

A Phase II Trial of Preoperative Proton Therapy in Soft-tissue Sarcomas of the Extremities and Body Wall

Completed NA Results posted Last updated 23 August 2023

What this trial tests

NA trial testing proton radiation in Soft Tissue Sarcoma in 7 participants. Completed in 19 May 2022.

Timeline

27 February 2013

Primary endpoint
19 May 2022

19 May 2022

Quick facts

Lead sponsor	Loma Linda University
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	treatment
Enrollment	7
Start date	27 February 2013
Primary completion	19 May 2022
Estimated completion	19 May 2022
Sites	1 location across United States

Drugs / interventions tested

• proton radiation
• surgery (wide local excision; limb preservation surgery)

Conditions studied

• Soft Tissue Sarcoma — all drugs for Soft Tissue Sarcoma →

Sponsor

Loma Linda University

Who can join

Adults 18 to 98, any sex, with Soft Tissue Sarcoma. 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.

Late Radiation Toxicities at 2 Years From the Start of Radiation Treatment Primary · at 2 years from the start of radiation treatment

To report the number of participants with late radiation morbidity Late subcutaneous fibrosis and joint stiffness are assessed using the European Organization for Research and Treatment of Cancer/Radiation Therapy Oncology Group (EORTC/RTOG) late toxicity scoring criteria below: Subcutaneous tissue: Grade 1(slight fibrosis; subcutaneous fat loss), Grade 2(moderate fibrosis: slight field contracture), Grade 3(severe fibrosis; field contracture \>10%), Grade 4(necrosis), Grade 0 (none) Joint stiffness: Grade 1(mild stiffness; slight range of motion loss), Grade 2(Moderate stiffness, pain, rang

Group	Value	95% CI
Preoperative Proton Radiation	0

Grade 3-5 Adverse Events at 6 Months From the Start of Radiation Treatment. Secondary · 6 months

This study will utilize the Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 for reporting of adverse events.

Group	Value	95% CI
Preoperative Proton Radiation	0

Patterns of Failure at 6 Months From the Start of Radiation Treatment Secondary · 6 months

Prespecified patterns of failure, including local failure, regional failure, distant failure, and death without disease progression at 6 months from the start of radiation treatment measured by CT or MRI scan

Group	Value	95% CI
Preoperative Proton Radiation	1

Patterns of Failure at 6 Months Secondary · 6 months

Patterns of failure including local failure, distant failure, distant-disease-free survival, disease-free survival, overall survival rates, and second primary tumor at 6 month from the start of radiation treatment on CT or MRI scan.

local failure

Group	Value	95% CI
Preoperative Proton Radiation	0

distant failure

Group	Value	95% CI
Preoperative Proton Radiation	1

distant-disease-free survival

Group	Value	95% CI
Preoperative Proton Radiation	5

disease-free survival

Group	Value	95% CI
Preoperative Proton Radiation	5

overall survival

Group	Value	95% CI
Preoperative Proton Radiation	6

second primary tumor

Group	Value	95% CI
Preoperative Proton Radiation	0

Wound Complication Rates Infection, Dehiscence at 6 Months From the Start of Radiation Treatment. Secondary · 6 months

Wound complications - Major wound complications, such as secondary operations, re-admissions, and/or invasive procedures for wound complication (deep wound packing and/or prolonged dressing changes) due to Infection, dehiscence.

Group	Value	95% CI
Preoperative Proton Radiation	1

Report of Late Radiation Morbidity at 2 Years Secondary · at 2 years

To report the number of participants with late radiation morbidity using quality of life survey including physical, emotional, social/family and functional well-being.

Group	Value	95% CI
Preoperative Proton Radiation	5

Adverse events — posted to ClinicalTrials.gov

Time frame: At 6 months and 2 years post-enrollment.. Reporting threshold: 0%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

Preoperative Proton Radiation

Serious: 1/6 (17%)

Deaths: 0/6

Serious adverse events (1 terms)

Reaction	System	Preoperative Proton Radiat…
dehiscence	Infections and infestations	—

Most-reported serious reactions: dehiscence.

Data from ClinicalTrials.gov NCT01819831 adverse events section.

Sponsor's own description

When treated with surgery alone, many soft-tissue sarcomas have a high chance of coming back. Radiation therapy is frequently used in addition to surgery to reduce the chances of the sarcoma coming back. However, radiation can have long-term side effects on the normal tissues surrounding the tumor, leading to problems such as swelling, scarring, and joint stiffness.

Recently, there have been advances in the way that radiation therapy can be given. Proton radiation therapy is one of those advances. With proton radiation, it is possible to give radiation over a smaller area surrounding the tumor, resulting in less radiation to the surrounding normal tissues.

The purpose of this study is to determine whether proton radiation decreases the long-term side effects of radiation on normal tissues and if smaller proton radiation fields reduce local recurrence compared to the larger radiation fields that have been used in prior studies.

Publications & conference data

4 peer-reviewed publications reference this trial (live from Europe PMC):

1. Proton beam therapy for cancer in the era of precision medicine.
   Hu M, Jiang L, Cui X, Zhang J, et al · · 2018 · cited 57× · PMID 30541578 · DOI 10.1186/s13045-018-0683-4
2. Radiation Therapy in Adult Soft Tissue Sarcoma-Current Knowledge and Future Directions: A Review and Expert Opinion.
   Roeder F. · · 2020 · cited 22× · PMID 33153100 · DOI 10.3390/cancers12113242
3. Postradiation Fractures after Combined Modality Treatment in Extremity Soft Tissue Sarcomas.
   Bartelstein MK, Yerramilli D, Christ AB, Kenan S, et al · · 2021 · cited 12× · PMID 33790687 · DOI 10.1155/2021/8877567
4. The role of radiotherapy in adult soft tissues sarcoma of the extremities.
   Cammelli S, Cortesi A, Buwenge M, Zamagni A, et al · · 2021 · cited 9× · PMID 33954820 · DOI 10.1007/s00590-021-02990-6