Clinical trial · Interventional
Intensity-Modulated Radiation Therapy in Treating Patients Undergoing Surgery for Stage IB, Stage II, or Stage III Soft Tissue Sarcoma
Phase II Study of Preoperative Intensity-Modulated Radiation Therapy for Soft-Tissue Sarcomas
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): No patients were enrolled on the study
Summary
Brief summary (as posted)
RATIONALE: Specialized radiation therapy that delivers a high dose of radiation directly to the tumor may kill more tumor cells and cause less damage to normal tissue. Giving radiation therapy before surgery may make the tumor smaller and reduce the amount of normal tissue that needs to be removed. PURPOSE: This phase II trial is studying the side effects of intensity-modulated radiation therapy and to see how well it works in treating patients undergoing surgery for stage IB, stage II, or stage III soft tissue sarcoma.
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 |
|---|---|---|---|
| Sarcoma | Sarcoma | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (6)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| gene expression analysis | Genetic | — | UNRESOLVED |
| intensity-modulated radiation therapy | Radiation | — | UNRESOLVED |
| neoadjuvant therapy | Procedure | — | UNRESOLVED |
| polymerase chain reaction | Genetic | — | UNRESOLVED |
| therapeutic conventional surgery | Procedure | — | UNRESOLVED |
| western blotting | Genetic | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Arm 1
- description
- pre-operative radiation + surgery PTV will receive a total dose of 50 Gy in 25 fractions, 2 Gy per fraction, 5 fractions per week, over approximately 5 weeks. Concurrently, the GTV2, if present, will receive 54 Gy in 25 fraction. Dose will be prescribed to the isodose volume that encompasses the PTV. All patients will be treated by 6 MV photon beam.
- interventionNames
- Genetic: gene expression analysis
- Genetic: polymerase chain reaction
- Genetic: western blotting
- Procedure: neoadjuvant therapy
- Procedure: therapeutic conventional surgery
- Radiation: intensity-modulated radiation therapy
Primary outcomes (1)
- measure
- Wound Complication Rate
- timeFrame
- 1 year
- description
- Major wound complications up to 4 months post surgery include: Complications requiring a secondary operation under general or regional anesthesia for wound care. Seroma aspiration. Drain placement. Minor wound debridement and wound care. Readmission for wound care such as intravenous antibiotics. Persistent wound deep packing or wound vacuum assisted closure for greater than 120 days.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
DISEASE CHARACTERISTICS: * Histologically confirmed soft tissue sarcoma (STS) for which neoadjuvant or adjuvant radiotherapy is considered standard care * Stage IB-III disease * Primary or locally recurrent disease * The following chemotherapy-sensitive STS histologies are excluded: * Primitive neuroectodermal tumor * Desmoplastic small round cell tumor * Synovial sarcoma * Myxoid round cell liposarcoma * Angiosarcoma * No sarcomas for which surgical staging and adjuvant radiotherapy are considered standard care (e.g., uterine sarcomas, including leiomyosarcoma, malignant mixed Müllerian tumors, and endometrial stromal sarcoma) * No retroperitoneal STS PATIENT CHARACTERISTICS: * ECOG performance status 0-2 * Able to complete the self-assessment questionnaires (may use translator service) * Willing and able to undergo pre-treatment core needle biopsies * Negative pregnancy test * No known HIV positivity PRIOR CONCURRENT THERAPY: * Prior adjuvant chemotherapy for STS allowed provided patient has locally recurrent disease * At least 1 year since prior adjuvant chemotherapy * No prior radiotherapy to the site of present STS * No other concurrent cytotoxic chemotherapy, targeted therapy, or investigational agents
References
Publications (0)
Data not yet available