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Palliative Radiotherapy in Symptomatic Pelvic Soft Tissue Tumors

Study acronym: PALLSOFT
StatusRecruiting
PhaseNot applicable
Started
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Record History

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  1. Eligibility criteria expanded, about 5 wordsv11
  2. Site details revised at 1 of 11 sitesv10
  3. Site details revised at 1 of 11 sitesv9
  4. Site details revised at 1 of 11 sitesv8
  5. Site details revised at 1 of 11 sitesv7
Show 5 earlier versionsHide 5 earlier versions
  1. Site details revised at 1 of 11 sitesv6
  2. Site details revised at 4 of 11 sitesv5
  3. Site details revised at 2 of 11 sitesv4
  4. Trial status: Not Yet Recruiting to Recruiting
    • Study sites: 0 to 11
    • Start date changed from estimate of Jan 2025 to Dec 10, 2024
    v3
  5. Start date: Sep 2024 to Jan 2025v2
  1. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.
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
(from sponsor)		 Gastrointestinal Cancer, Urologic Cancer, Gynecologic Cancer
Related terms Gastrointestinal Neoplasms, Urologic Neoplasms
Enrollment 200 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov