NCT06398314

Palliative Radiotherapy in Symptomatic Pelvic Soft Tissue Tumors

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 200 (estimated)
• Sponsor: Sykehuset Telemark · Other Government
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

PALLSOFT is a randomized, open-label, non-inferiority phase III, multicenter, national trial that will investigate whether the patient-reported symptomatic effect of palliative radiotherapy delivered in 1-2 fractions is non-inferior to palliative radiotherapy delivered in five fractions in patients with pelvic soft tissue tumors from either gastrointestinal, urological or gynecological cancer. Health-related quality of life, toxicities, survival and prognostic and predictive biomarkers will be assessed as secondary and explorative endpoints.

Detailed description

Studies and clinical practice have proven palliative radiotherapy to provide efficient symptom relief in patients with symptomatic pelvic soft tissue tumors. However, studies are mainly retrospective, are difficult to compare due to a variety of radiotherapy fractionation schedules used, and lack data on patient-reported quality of life. Consequently, no recommended standard of care is established, and several schedules are employed with variations in both number of fractions and total radiation dose (measured in Gray=Gy). Given the limited life expectancy of palliative patients, a short-course radiotherapy schedule would be preferable provided efficient symptom relief and good health-related quality of life. PALLSOFT is a national, randomized, non-inferiority study that will investigate whether the symptomatic effect of a short-course radiotherapy schedule of 8 Gy x 1-2 is non-inferior to a more prolonged schedule of 5 Gy x 5. The study will include patients with symptomatic pelvic soft tissue tumors from either gastrointestinal, urological or gynecological cancer. Patients will defined a target symptom from 5 predefined cathegories (pain, bleeding, bowel/lower urinary tract/vaginal dysfunction), and change in symptom intensity will be assessed, as well as overall toxicities, quality of life and survival. Prognostic and predictive biomarkers will be explores, the latter with particular emphasis on the significance of tumor hypoxia in palliative radiotherapy.

Conditions

• Gastrointestinal Cancer
• Urologic Cancer
• Gynecologic Cancer

Interventions

Type	Name	Description
RADIATION	Palliative radiotherapy	Hypofractionated radiotherapy

Timeline

• Start date: 2024-12-10
• Primary completion: 2029-12-01
• Completion: 2030-12-01
• First posted: 2024-05-03
• Last updated: 2025-05-23

Locations

11 sites across 1 country: Norway