Study Comparing Short and Longer Schedules of Palliative Radiotherapy for Symptomatic Pelvic Soft Tissue Tumors from Gastrointestinal, Urological, or Gynecological Cancers

What this Trial Is About

Researchers are investigating palliative radiotherapy for patients with symptomatic pelvic soft tissue tumors from gastrointestinal, urological, or gynecological cancers. This national, randomized, open-label phase III trial aims to determine if a short-course radiotherapy schedule 1-2 fractions of 8 Gy provides symptom relief that is not worse than a longer schedule 5 fractions of 5 Gy. The study also evaluates health-related quality of life, toxicities, survival, and biomarkers related to tumor hypoxia as secondary and exploratory goals. Participants will receive either a short-course radiotherapy treatment of 8 Gy in 1-2 sessions or a longer course of 5 Gy in 5 sessions. Both schedules are delivered as palliative care to relieve symptoms such as pain, bleeding, or dysfunction in bowel, urinary, or vaginal areas. Patients will choose a main symptom to track during the study. The trial specifically excludes curative treatments and focuses on symptom control with radiation therapy. During the study, patients are monitored through patient-reported symptom intensity assessments, physician-reported toxicities up to 52 weeks, and survival evaluations over two years. Researchers will also collect quality of life data and explore biomarkers to better understand treatment effects. Participation involves regular symptom reporting and clinical follow-up, with the primary outcome measured 12 weeks after treatment.

Palliative Radiotherapy in Symptomatic Pelvic Soft Tissue Tumors