Palliative Radiotherapy in Symptomatic Pelvic Soft Tissue Tumors

Sponsor
Sykehuset Telemark
Study ID
NCT06398314
Status
Recruiting
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Conditions

  • Gastrointestinal Cancer
  • Gynecologic Cancer
  • Urologic Cancer

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Palliative radiotherapy — RADIATION
    Hypofractionated radiotherapy

Study Details

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.

Key Dates

First listed
May 3, 2024
Start date
Dec 10, 2024
Status verified
Mar 2025
Primary completion
Dec 31, 2029
Completion
Dec 31, 2030

Study Design

Enrollment
200 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Active Comparator: 1-2 fractions of 8 Gy (Gray)
  • Active Comparator: 5 fractions of 5 Gy (Gray)

Primary Outcome Measure

Patient-reported symptomatic effect [ Time Frame: 12 weeks ]

Central Contacts

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