Pre-operative hypofractionated radiotherapy for soft tissue sarcomas

Short Course Pre-operative RadiothErapy for Soft Tissue SarcOmas - a Phase I/II Trial (PRESTO)

This study is testing a new way of giving radiation therapy before surgery for patients with localized soft tissue sarcomas to see if it can speed up surgery and lower complications compared to the usual treatment.

Quick facts

• Phase: NA
• Study type: Interventional
• Enrollment: 15 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: McGill University Health Centre/Research Institute of the McGill University Health Centre (other)
• Drugs / interventions: radiation
• Locations: 1 site (Montréal, Quebec)
• Trial ID: NCT04617327 on ClinicalTrials.gov

What this trial studies

This study evaluates the effectiveness of hypofractionated radiotherapy, delivering five fractions of 7 Gy over a short period, for patients with localized soft tissue sarcomas (STS) who are scheduled for surgery. The aim is to determine if this approach can reduce the time to surgery and minimize complications compared to traditional radiotherapy regimens. Patients will undergo a series of assessments before and after treatment to monitor acute and late toxicity, as well as quality of life. The study will involve a comprehensive follow-up to assess the long-term outcomes of the treatment.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18 and older with histologically proven localized soft tissue sarcomas of the extremities or trunk, who are suitable for preoperative radiotherapy.

Not a fit: Patients with lesions below the knee or those who have undergone unplanned non-oncological excision are unlikely to benefit from this study.

Why it matters

Potential benefit: If successful, this approach could lead to improved surgical outcomes and reduced complications for patients with soft tissue sarcomas.

How similar studies have performed: While hypofractionated radiotherapy is a novel approach in this context, similar studies have shown promise in other cancer types, suggesting potential for success.

Eligibility criteria

Inclusion Criteria:

* Histologically proven STS of the extremities, above the knee, or trunk following review by our pathologist

  * Lesions smaller than 15cm in largest dimension
  * Deemed appropriate for preoperative radiotherapy and conservative surgery following patient assessment by a radiation oncologist and surgical oncologist
  * Lesion is primary or locally recurrent. Patients who underwent unplanned non-oncological excision ("whoops" procedure) at a referring hospital are NOT eligible
  * No previous radiation therapy
  * ECOG 0-2 (or Karnofsky Performance Status ≥ 70) within 60 days prior to registration
  * Resectable primary lesion with or without distant metastasis
  * Age ≥ 18
  * Patient must be able to provide study-specific informed consent prior to study entry
  * Patient is available for treatment and follow-up

Exclusion Criteria:

* Patients who underwent unplanned non-oncological excision ("whoops" procedure) at a referring hospital

  * Lesions below the knee
  * Prior or concurrent invasive malignancy (except non-melanomatous skin cancer) or lymphomatous/hematogenous malignancy, unless continually disease free for a minimum of 5 years
  * Regional lymph node involvement
  * Previous irradiation to the area to be treated
  * Other major medical illness deemed to preclude safe administration of protocol treatment or required follow-up

Where this trial is running

Montréal, Quebec

• McGill University Health Centre-Cedars Cancer Centre — Montréal, Quebec, Canada (RECRUITING)

Study contacts

• Principal investigator: Fabio Cury, MD — Research Institute of McGill University Health Centre
• Study coordinator: Fabio Cury, MD

Conditions: Soft Tissue Sarcoma Adult