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Short Course of Radiotherapy Prior to Surgery of Soft Tissue Sarcomas

NCT ID: NCT07071727

Last Updated: 2025-12-23

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

150 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-12-11

Study Completion Date

2033-11-01

Brief Summary

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Based upon the preliminary data derived from first SCOPES clinical trial and the results of patients treated during the recent COVID-19 pandemic, patients with soft tissue sarcomas (STS) can be preoperatively irradiated in a modestly hypofractionated schedule of 14 x 3 Gy. From a toxicity and efficacy point of view, this regimen equals the outcomes after a conventionally fractionated regimen of 25 x 2 Gy in five weeks. Moreover, the rationale for investigating (modest) hypofractionation in the clinic comes both from a logistic point of view (patient convenience and a lower pressure on radiotherapy equipment), form prior phase II clinical evidence and from (cellular) radiobiological observations. There is phase II trial evidence suggesting that even more (ultra-) hypofractionation to 5 x 6 Gy is also safe and effective. Within this study, patients will be randomized to receive either the modestly hypofractionated conventional schedule of 14 x 3 Gy or an even shorter preoperative regimen of 5 x 6 Gy, in the hypothesis that both the postoperative wound complication rate until 120 days after surgery, as well as the local control probability at two years are comparable in both arms.

Detailed Description

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Conditions

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Sarcoma of Soft Tissue Sarcoma Sarcoma, Soft Tissue

Keywords

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preoperative radiotherapy radiotherapy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Randomization between two study arms: arm A of 14 x 3 Gy in 3 weeks and arm B of 5 x 6 Gy in one week.
Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Arm A

Arm A: Preoperative radiotherapy to a total dose of 42 Gy in 14 once daily fractions of 3 Gy, in an overall treatment time of three weeks.

Group Type OTHER

Preoperative radiotherapy

Intervention Type RADIATION

preoperative radiotherapy

Arm B

Arm B: Preoperative radiotherapy to a total dose of 30 Gy in 5 once daily fractions of 6 Gy, in an overall treatment time of one week.

Group Type OTHER

Preoperative radiotherapy

Intervention Type RADIATION

preoperative radiotherapy

Interventions

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Preoperative radiotherapy

preoperative radiotherapy

Intervention Type RADIATION

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Institute of Oncology in Warsaw

UNKNOWN

Sponsor Role collaborator

Radboud University Medical Center

OTHER

Sponsor Role collaborator

University Medical Center Groningen

OTHER

Sponsor Role collaborator

Leiden University Medical Center

OTHER

Sponsor Role collaborator

Amsterdam UMC

OTHER

Sponsor Role collaborator

Erasmus Medical Center

OTHER

Sponsor Role collaborator

Maastro

UNKNOWN

Sponsor Role collaborator

The Netherlands Cancer Institute

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Netherlands Cancer Institute

Amsterdam, , Netherlands

Site Status NOT_YET_RECRUITING

AUMC

Amsterdam, , Netherlands

Site Status RECRUITING

UMCG

Groningen, , Netherlands

Site Status NOT_YET_RECRUITING

LUMC

Leiden, , Netherlands

Site Status NOT_YET_RECRUITING

Maastro

Maastricht, , Netherlands

Site Status RECRUITING

RadboudUMC

Nijmegen, , Netherlands

Site Status NOT_YET_RECRUITING

Countries

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Netherlands

Central Contacts

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Lisette M Wiltink, MD, PhD

Role: CONTACT

Phone: +31205129111

Email: [email protected]

R L M Haas, MD, PhD

Role: CONTACT

Phone: 0205129111

Email: [email protected]

Facility Contacts

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L M Wiltink, MD PhD

Role: primary

Balgobind

Role: primary

Ubbels

Role: primary

Krol

Role: primary

Wesseling

Role: primary

Braam

Role: primary

Other Identifiers

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M24SCT

Identifier Type: -

Identifier Source: org_study_id

NL009842

Identifier Type: OTHER

Identifier Source: secondary_id