Short Course Of Preoperative Radiotherapy in Head and Neck-, Trunk- and Extremity Soft Tissue Sarcomas

NCT04425967 | Active Not Recruiting

• 1 other identifier: M20SCP
• Study Type: interventional
• Target: 168
• Locations: 1 country
• Sites: 4

Brief Summary

Currently, soft tissue sarcomas (STS) are preoperatively irradiated in a conventionally fractionated regimen of 25 x 2 Gy in five weeks. Recent radiobiological investigations, however, suggest sensitivity to (modest) hypofractionation. Within this study, patients will be randomized to receive either the conventional schedule of 25 x 2 Gy or a shorter preoperative regimen of 14 x 3 Gy, in the hypothesis that both the postoperative wound complication rate until 30 days after surgery, as well as the local control probability at two years are comparable in both arms.

Conditions

Soft Tissue Sarcomas

Keywords

preoperative radiotherapy

Outcome Measures

Primary Outcomes (1)

• the short-term toxicity

  wound complications

  30 days post operative

Secondary Outcomes (3)

• local control

  During follow up (5 years)

• long-term toxicity

  During follow up (5 years)

• Wound complication rate

  From surgery until 120 days post-surgery

Study Arms (2)

25x2Gy

ACTIVE COMPARATOR

the conventional schedule of 25 x 2 Gy, once daily fractionation in a five-week OTT

Radiation: pre-operative radiotherapy

14x3Gy

EXPERIMENTAL

the study schedule of 14 x 3 Gy, once daily fractionation in a three-week overall treatment time

Radiation: pre-operative radiotherapy

Interventions

pre-operative radiotherapy RADIATION

pre-operative radiotherapy

Also known as: radiotherapy

14x3Gy; 25x2Gy

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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);

Sponsors & Collaborators

• The Netherlands Cancer Institute: lead
• Leiden University Medical Center: collaborator

Study Sites (4)

Universitair Medisch Centrum Groningen

Groningen, 9713GZ, Netherlands

Location

Leids Universitair Medisch Centrum

Leiden, 2333ZA, Netherlands

Location

Radboudumc

Nijmegen, 6525GA, Netherlands

Location

Erasmus Medical Centre

Rotterdam, Netherlands

Location

MeSH Terms

Conditions

Sarcoma

Interventions

Radiotherapy

Condition Hierarchy (Ancestors)

Neoplasms, Connective and Soft Tissue; Neoplasms by Histologic Type; Neoplasms

Intervention Hierarchy (Ancestors)

Therapeutics

Study Officials

• Rick Haas, MD, PhD

  The Netherlands Cancer Institute

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: randomization between the standard arm A of 50 Gy in 5 weeks or arm B with hypofractination of 14x3Gy

Study Record Dates

• First Submitted: June 3, 2020
• First Posted: June 11, 2020
• Study Start: June 25, 2021
• Primary Completion: May 1, 2026
• Study Completion (Estimated): May 1, 2031
• Last Updated: January 20, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

NL (4)