SCOPES II

Short Course of Radiotherapy Prior to Surgery of Soft Tissue Sarcomas (SCOPES II)

Agent: Preoperative Radiotherapy
Phase II
Status Recruiting
Sponsor The Netherlands Cancer Institute

 

For further information please also consult https://www.clinicaltrials.gov/study/NCT07071727

Based on early data from the first SCOPES trial and experience during the COVID-19 pandemic, patients with soft tissue sarcomas (STS) can safely receive preoperative radiation in a shorter schedule of 14 sessions of 3 Gy. This approach appears just as safe and effective as the standard 25 sessions of 2 Gy over five weeks.

There are practical reasons to study shorter treatments—such as making therapy more convenient for patients and reducing pressure on radiotherapy machines—as well as supportive clinical and biological evidence. Phase II studies even suggest that an ultra-short schedule of 5 sessions of 6 Gy can also work well.

In this study, patients will be randomly assigned to either the 14×3 Gy schedule or the shorter 5×6 Gy schedule. Researchers expect that both groups will have similar rates of wound-healing problems within 120 days after surgery and similar local tumor control after two years.

 

WHO is the trial for?
  • Adult patients with histologically confirmed intermediate to high grade soft tissue sarcoma in the head and neck area, the trunk and chest wall or the extremities, for which the standard treatment is a combination of radiotherapy and surgery.
  • No 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.
  • Overall health of the patient must be good (WHO Performance Status ≤ 2)

WHAT is the key question that this trial is attempting to answer?

 Is the short course of preoperative radiotherapy (5 x 6 Gy) comparable to the modestly hypofractionated conventional schedule (14 x 3 Gy) in terms of efficacy and safety?

Is a shorter course of radiotherapy — 5 treatments of a slightly higher dose (6 Gy) — as effective and safe as the longer course of 14 smaller-dose (3 Gy) treatments before surgery?

WHY patients might want to participate?

 This clinical trial offers patients an opportunity to access a new therapy strategy. This trial will further support the research in sarcomas and potentially help other patients with this disease.

The trial might or might not have benefit in your individual case.

WHEN will the trial be open?

 This study is open for recruitment.

WHERE is the trial available?

 The trial is being conducted in the Netherlands (AUMC Amsterdam, MAASTRO Clinic, Maastricht). Poland will open the trial shortly.

For further information check here.

Contact :
L M Wiltink, MD PhD
E-Mail: l.m.wiltink@lumc.nl

STUDY DESIGN: What does the study look like?

 For preoperative radiotherapy, the patients will be randomized (assigned by random choice) to one of the following treatment arms:

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

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

HOW do I get more information?

 Patient organisations supporting sarcoma patients in your country may offer additional information about the trial, current recruitment status, and key contacts. Click here for a list of patient organisations serving sarcoma patients.

 

If there are no such organisation in your country, please email us for more information: info@sarcoma-patients.org

 

Disclaimer: This is a patient-friendly summary of the clinical trial which has been provided for informational purposes only. Patients should consult their physician about any clinical trial opportunity.

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