Clinical Trial

Palliative Radiotherapy in Symptomatic Pelvic Soft Tissue Tumors

Study acronym: PALLSOFT
Recruiting
View on ClinicalTrials.gov →
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.
Protocol Amendment History 10 amendments
This ClinicalTrials.gov record has been amended 10 times since 2024-05-02; most recent amendment 2025-05-22.
Status change: Not Yet Recruiting → Recruiting 2024-12-10
Trial Details
NCT Number NCT06398314
Lead Sponsor Sykehuset Telemark
Collaborators: Nordlandssykehuset HF, Møre og Romsdal Hospital Trust, Helse Stavanger HF, Hospital of Southern Norway Trust, Oslo University Hospital, Vestre Viken Hospital Trust, Sykehuset Innlandet HF, St. Olavs Hospital, Haukeland University Hospital, University Hospital of North Norway, South-Eastern Norway Regional Health Authority
Conditions Gastrointestinal Cancer, Urologic Cancer, Gynecologic Cancer
Enrollment 200 participants
Start Date 2024-12-10
Primary Completion 2029-12 (estimated)
Study Completion 2030-12 (estimated)
Updated on ClinicalTrials.gov 2025-05-23