Clinical trial · Interventional
Phase II Study of 5-Day Hypofractionated Preoperative Radiation Therapy for Soft Tissue Sarcomas: Expansion Cohort
NCT02701153CI-TRIAL-00105080recruitingN/AClinicalTrials.gov clinicaltrialsProvenance
- 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)
This phase II trial studies the side effects of hypofractionated radiation therapy in treating patients with soft tissue sarcomas prior to surgery. Hypofractionated radiation therapy delivers higher doses of radiation therapy over a shorter period of time and may kill more tumor cells and have fewer side effects.
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 |
|---|---|---|---|
| Recurrent Adult Soft Tissue Sarcoma | Adult Soft Tissue Sarcoma | CURATED_BROADER | 0.78 |
Interventions
Interventions (4)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Conventional Surgery | Procedure | — | UNRESOLVED |
| Hypofractionated Radiation Therapy | Radiation | — | UNRESOLVED |
| Laboratory Biomarker Analysis | Other | — | UNRESOLVED |
| Questionnaire Administration | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Treatment (hypofractionated radiation therapy)
- description
- Patients undergo hypofractionated radiation therapy on Monday-Friday for 5 days. Beginning 2-12 weeks after completion of radiation therapy, patients undergo surgery.
- interventionNames
- Procedure: Conventional Surgery
- Radiation: Hypofractionated Radiation Therapy
- Other: Laboratory Biomarker Analysis
- Other: Questionnaire Administration
Primary outcomes (1)
- measure
- Grade >= 2 radiation morbidity (subcutaneous tissue fibrosis, joint stiffness, or edema)
- timeFrame
- Up to 2 years
- description
- Interim reports will be prepared every six months until the results of the study are published. In general, the interim reports will contain information about patient accrual rate with projected completion dates, status of question-answer (QA) review and compliance rate of treatment per protocol, and the frequencies and severity of toxicity.
Secondary outcomes (5)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Histologically confirmed soft tissue sarcoma of the extremity/trunk * Intermediate or high grade sarcoma * Resectable primary lesion (patients with pre-existing metastasis will be included if their primary is still going to be resected) * Recurrent, any grade, no previous radiation therapy * Karnofsky performance status (KPS) \>= 70 or Eastern Cooperative Oncology Group (ECOG) 0 - 2 * If a woman is of childbearing potential, a negative serum pregnancy test must be documented Exclusion Criteria: * Active treatment of a separate malignancy * History of prior irradiation to the area to be treated * Pre-operative chemotherapy (post-op acceptable)
References
Publications (1)
- DERIVEDNikitas J, Kendal JK, Savjani RR, Jackson N, Peterson N, Deng J, Hernandez J, Chong N, Singh AS, Chmielowski B, Federman NC, Crompton JG, Kadera BE, Wessel LE, Christ AB, Nelson SD, Dry SM, Weidhaas JB, Steinberg ML, Bernthal NM, Eilber FC, Kalbasi A, Reddy VK. Five-Day Preoperative Radiation Therapy for Patients With High-Risk Soft Tissue Sarcoma: A Nonrandomized Clinical Trial. JAMA Netw Open. 2025 Dec 1;8(12):e2550195. doi: 10.1001/jamanetworkopen.2025.50195. PMID 41405883