Clinical trial · Interventional
Preoperative vs Postoperative IMRT for Extremity/Truncal STS
Phase III Study of Preoperative vs Postoperative Intensity Modulated Radiation Therapy For Truncal/Extremity Soft Tissue Sarcoma
- 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 study is designed to determine if preoperative image guided radiation therapy (IGRT) delivered using intensity modulated radiation therapy (IMRT) followed by surgery results in similar short-term wound healing complications as surgery followed by postoperative IGRT in patients with extremity or truncal soft tissue sarcoma. Half of the patients will receive preoperative radiotherapy, half will receive postoperative radiotherapy.
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 |
|---|---|---|---|
| Adult Soft Tissue Sarcoma | Adult Soft Tissue Sarcoma | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Postoperative intensity modulated radiation therapy | Radiation | — | UNRESOLVED |
| Preoperative intensity modulated radiation therapy | Radiation | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- OTHER
- label
- Preoperative Radiation Therapy (Arm A)
- description
- Preoperative intensity modulated radiation therapy followed by surgery
- interventionNames
- Radiation: Preoperative intensity modulated radiation therapy
- type
- EXPERIMENTAL
- label
- Postoperative Radiation Therapy (Arm B)
- description
- Surgery followed by postoperative intensity modulated radiation therapy
- interventionNames
- Radiation: Postoperative intensity modulated radiation therapy
Primary outcomes (1)
- measure
- Incidence of acute wound healing complications
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: 1. Histologically proven soft tissue sarcoma of the extremity or trunk following review by local reference pathologist. 2. Deemed appropriate for preoperative or postoperative radiotherapy and conservative surgery following patient assessment by a radiation oncologist and surgical oncologist. 3. Lesion is primary or locally recurrent. Patient may have undergone excisional biopsy with positive margins at a referring hospital and are eligible following discussion among the surgical oncologists and radiation oncologists that IMRT is an acceptable treatment for that case. 4. Eastern Cooperative Oncology Group (ECOG) score 0-3 5. Patient is aged 18years or older. 6. Patient is able to provide informed consent 7. Patient is available for treatment and follow-up. Exclusion Criteria: 1. Benign histology. 2. Prior malignancy within the previous five years or concurrent malignancy with the exception of adequately treated basal cell carcinoma of the skin or carcinoma in-situ of the cervix. 3. Prior radiotherapy to the target site 4. Planned chemotherapy for (neo)adjuvant treatment 5. Conservative surgery to the target site 6. Presence of regional nodal disease or unequivocal distant metastases. 7. Other major medical illness deemed to preclude safe administration of protocol treatment or required follow-up.
References
Publications (0)
Data not yet available