Short course of preoperative radiotherapy for soft tissue sarcomas

Short Course of Preoperative Radiotherapy in Head and Neck-, Trunk- and Extremity Soft Tissue Sarcomas; a Randomized Phase II Clinical Trial

This study tests if a shorter course of radiation before surgery can help people with soft tissue sarcomas have fewer complications and control their tumors just as well as the standard longer treatment.

Quick facts

• Phase: NA
• Study type: Interventional
• Enrollment: 163 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: The Netherlands Cancer Institute (other)
• Drugs / interventions: chemotherapy
• Locations: 4 sites (Groningen and 3 other locations)
• Trial ID: NCT04425967 on ClinicalTrials.gov

What this trial studies

This study investigates the effectiveness of a shorter preoperative radiotherapy regimen compared to the conventional approach for patients with soft tissue sarcomas. Participants will be randomly assigned to receive either the standard treatment of 25 x 2 Gy over five weeks or a shorter course of 14 x 3 Gy. The primary focus is to compare the rates of postoperative wound complications and local control of the tumor at two years. The goal is to determine if the shorter regimen can maintain similar outcomes while potentially reducing treatment duration and side effects.

Who should consider this trial

Good fit: Ideal candidates include individuals with newly diagnosed intermediate to high-grade soft tissue sarcomas localized to specific areas such as the extremities, trunk, or head and neck.

Not a fit: Patients with metastatic disease or those who do not meet the eligibility criteria for preoperative radiotherapy and surgery may not benefit from this study.

Why it matters

Potential benefit: If successful, this approach could lead to more efficient treatment protocols for patients with soft tissue sarcomas, minimizing complications and improving surgical outcomes.

How similar studies have performed: Previous studies have shown promising results with preoperative radiotherapy, suggesting that this approach may be effective, although the specific shorter regimen is being tested for the first time.

Eligibility criteria

Inclusion Criteria:

* Histologically confirmed newly diagnosed intermediate to high grade soft tissue sarcoma localized to the extremities, trunk and chest wall or the head and neck area, for which the standard treatment is a combination of and radiotherapy and surgery (deep seated and/or \> 5cm in largest tumor diameter and/or an anticipated close resection margin and/or grade II/III according to the FNCLCC definition);
* • Absence of regional and/or distant disease. Patients staged by at least a CT scan of the chest (. Staging may also be performed by FDG-PET scanning and or total body MRI scans. Patients with an uncertain metastatic status (e.g. small indifferent lung nodules) and patients with a low metastatic burden not precluding the application of both preoperative radiotherapy and definitive surgery, are allowed to participate;
* WHO Performance Status ≤ 2;
* Able and willing to undergo preoperative radiotherapy;
* Able and willing to undergo definitive surgery;
* Able and willing to comply with regular follow-up visits;
* Able and willing to complete patient reported outcome questionnaires (health-related quality of life and cost effectiveness);

  • Able and willing to undergo randomization;
* Age ≥ 18 years;
* Signed written informed consent

Exclusion Criteria:

* Prior malignancies; except another malignancy and disease-free for ≥ 5 years, or completely resected non-melanomatous skin carcinoma or successfully treated in situ carcinoma;
* Patients with recurrent sarcomas who underwent prior radiotherapy to the target lesion (if the primary sarcoma was managed by surgery only and no perioperative RT, patients are eligible);
* Ewing sarcoma and other PNET family tumors, rhabdomyosarcomas (both pediatric and adult), osteosarcomas;
* Any psychological, familial, sociological or geographical condition potentially hampering compliance with the study protocol and follow-up schedule; those conditions should be discussed with the patient before registration in the trial;
* Female patients who are pregnant;
* Intention to perform an isolated limb perfusion, instead of a tumor resection;
* Neoadjuvant chemotherapy to be scheduled between end of radiotherapy and definitive surgery (neoadjuvant chemotherapy before radiotherapy is allowed);

Where this trial is running

Groningen and 3 other locations

• Universitair Medisch Centrum Groningen — Groningen, Netherlands (RECRUITING)
• Leids Universitair Medisch Centrum — Leiden, Netherlands (RECRUITING)
• Radboudumc — Nijmegen, Netherlands (RECRUITING)
• Erasmus Medical Centre — Rotterdam, Netherlands (RECRUITING)

Study contacts

• Principal investigator: Rick Haas, MD, PhD — The Netherlands Cancer Institute
• Study coordinator: Rick Haas, MD, PhD

Conditions: Soft Tissue Sarcomas, preoperative radiotherapy