Clinical trial · Interventional
Hypofractionated Pre-operative Radiation Therapy for Soft Tissue Sarcomas of the Extremity and Chest-wall
Pilot Study Evaluating Hypofractionated Pre-operative Radiation Therapy for Soft Tissue Sarcomas of the Extremity and Chest-wall
NCT02634710CI-TRIAL-00098243completedN/AResults postedClinicalTrials.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 is a nonrandomized Phase II pilot protocol to determine the feasibility, toxicity and disease control (local control, overall and progression-free survival) using hypofractionated preoperative radiation therapy in patients with primary localized soft tissue sarcomas (STS).
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 (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Hypofractionated Radiation Therapy | Radiation | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Hypofractionated Radiation Therapy
- description
- Radiation treatment in which the total dose of radiation is divided into large doses and treatments are given every other day. Hypofractionated radiation therapy is given over a shorter period of time (fewer days or weeks) than standard radiation therapy.
- interventionNames
- Radiation: Hypofractionated Radiation Therapy
Primary outcomes (2)
- measure
- Local Disease Control Assessed by Physical Examination
- timeFrame
- 2 Years
- description
- This measure will capture the number of subjects experiencing a recurrence of the primary lesion assessed by physical examination.
- measure
- Local Disease Control Assessed by Magnetic Resonance Imaging (MRI)
- timeFrame
- 2 years
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * ≥ 18 years of age * Core needle biopsy obtained * Pathologic confirmation of primary soft tissue sarcoma of the upper or lower extremity or chest-wall. * Stage I-III Soft Tissue Sarcoma of the extremity without evidence of metastatic disease * Medically operable * No prior radiotherapy to primary site or adjacent site that results in overlapping radiation fields. * MRI obtained of the affected extremity or chest-wall * CT chest acquired to assess distant disease * Karnofsky Performance Status (KPS) 60 or above * Informed consent obtained prior to study entry Exclusion Criteria: * Patients who have metastatic disease * Pregnant women * Women of childbearing potential and male participants must practice adequate contraception. * Disease pathology other than sarcoma subtypes * Patients with a history of metastatic disease from a primary other than sarcoma * Patients who cannot undergo MRI as part of pre-treatment or treatment planning process * STS of non-extremity or chest-wall regions * Tumor size ≥ 20 cm maximal dimension
References
Publications (1)
- RESULTBedi M, Singh R, Charlson JA, Kelly T, Johnstone C, Wooldridge A, Hackbarth DA, Moore N, Neilson JC, King DM. Is 5 the New 25? Long-Term Oncologic Outcomes From a Phase II, Prospective, 5-Fraction Preoperative Radiation Therapy Trial in Patients With Localized Soft Tissue Sarcoma. Adv Radiat Oncol. 2022 Jan 25;7(3):100850. doi: 10.1016/j.adro.2021.100850. eCollection 2022 May-Jun. PMID 35647402