Clinical trial · Interventional
A Phase II Trial of Preoperative Proton Therapy in Soft-tissue Sarcomas of the Extremities and Body Wall
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Soft Tissue Sarcoma | Soft Tissue Sarcoma | ONTOLOGY_EXACT | 0.90 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| proton radiation | Radiation | — | UNRESOLVED |
| surgery (wide local excision; limb preservation surgery) | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Preoperative proton radiation
- description
- Patients will receive 50 Gray equivalents (GyE) in 25 fractions with proton therapy, followed by surgery 4-8 weeks after completion of radiation.
- interventionNames
- Radiation: proton radiation
- Procedure: surgery (wide local excision; limb preservation surgery)
Primary outcomes (1)
- measure
- Late Radiation Toxicities at 2 Years From the Start of Radiation Treatment
- timeFrame
- at 2 years from the start of radiation treatment
- description
- 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, range of motion loss), Grade 3(Severe stiffness, pain, range of motion loss), Grade 4(necrosis; complete fixation), Grade 0 (none) Lymphedema is measured according to the criteria of Stern: Score 0(none), Score 1(Mild but definite swelling), Score 2(Moderate), Score 3(Severe, considerable swelling), Grade 4(Very severe (skin shiny \& tight)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 98 Years
Show eligibility criteria text
Inclusion Criteria: * Histologically proven primary soft tissue sarcoma of the upper extremity (including shoulder), lower extremity (including hip) or body trunk (excluding retroperitoneum). * No clinical evidence of distant metastatic disease * Evaluation by surgeon, with documentation that the tumor is resectable * ECOG performance status 0-1 * For females of childbearing potential, a serum pregnancy test within 4 weeks prior to registration * Patient must practice adequate contraception * Adequate bone marrow function Exclusion Criteria: * Patients with sarcoma of the head, neck, intra-abdominal or retroperitoneal region, hand or foot * Histopathology demonstrating rhabdomyosarcoma, extraosseous primitive neuroectodermal tumor (PNET), soft tissue Ewing's sarcoma, osteosarcoma, Kaposi's sarcoma, angiosarcoma, aggressive fibromatosis, dermatofibrosarcoma protuberans or chondrosarcoma * Clinical evidence of regional lymph node or distant metastatic disease * Prior invasive malignancy (except non-melanomatous skin cancer or early stage prostate cancer) unless disease free for a minimum of 3 years * Prior radiotherapy to the potential target anatomic region would result in overlap of radiation fields for current sarcoma * Pregnancy or women of childbearing potential and men who are sexually active and not willing/able to used medically acceptable forms of contraception
References
Publications (0)
Data not yet available