Short Course of Radiotherapy Prior to Surgery of Soft Tissue Sarcomas

Launched by THE NETHERLANDS CANCER INSTITUTE · Jul 8, 2025

Keywords

ClinConnect Summary

This clinical trial is studying a new way to give radiation therapy before surgery for people with soft tissue sarcomas, which are a type of cancer that develops in the soft tissues like muscles or fat. The trial compares two different radiation schedules: one is a shorter course with 5 treatments, and the other is a slightly longer course with 14 treatments. Both approaches aim to shrink the tumor and make surgery more effective, while keeping side effects and wound healing problems similar. The goal is to find out if the shorter treatment is just as safe and effective as the longer one, which could make treatment quicker and more convenient for patients.

People who might join this study are adults with certain types of soft tissue sarcomas that are fairly large or deep in areas like the arms, legs, trunk, or head and neck, and who do not have cancer spread elsewhere in the body. Participants must be able to have both radiation and surgery, and agree to follow-up visits and questionnaires about their health and quality of life. Women who are pregnant or people with certain types of sarcomas or previous cancers are not eligible. If you take part, you will be randomly assigned to one of the two radiation treatment plans before surgery, and doctors will closely monitor your recovery and cancer control for up to two years after surgery to see which approach works best.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • Histologically confirmed intermediate to high grade soft tissue sarcoma localized to the head and neck area, to the trunk and chest wall or to the extremities, 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 must be 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;
• • 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 locally recurrent sarcomas, regardless of the management of the first sarcoma diagnosis;
• • Ewing sarcoma and other PNET family tumors, rhabdomyosarcomas (both pediatric and adult), osteosarcomas;
• • Myxoid liposarcomas, because they have shown to be exquisitely sensitive to a lower dose of radiation as compared to the 2 regimens tested in this trial.
• • 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 both before and after radiotherapy.