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Palliative Radiotherapy in Symptomatic Pelvic Soft Tissue Tumors

NCT06398314 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 200

Last updated 2025-05-23

No results posted yet for this study

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.

Conditions

Interventions

RADIATION

Palliative radiotherapy

Hypofractionated radiotherapy

Sponsors & Collaborators

  • Nordlandssykehuset HF

    collaborator OTHER

  • Møre og Romsdal Hospital Trust

    collaborator OTHER

  • Helse Stavanger HF

    collaborator OTHER_GOV

  • Hospital of Southern Norway Trust

    collaborator OTHER

  • Oslo University Hospital

    collaborator OTHER

  • Vestre Viken Hospital Trust

    collaborator OTHER

  • Sykehuset Innlandet HF

    collaborator OTHER

  • St. Olavs Hospital

    collaborator OTHER

  • Haukeland University Hospital

    collaborator OTHER

  • University Hospital of North Norway

    collaborator OTHER

  • South-Eastern Norway Regional Health Authority

    collaborator OTHER

  • Sykehuset Telemark

    lead OTHER_GOV

Principal Investigators

  • Harald Ragnum, MD,PhD · Telemark Hospital Trust

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-12-10
Primary Completion
2029-12-31
Completion
2030-12-31

Countries

  • Norway

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06398314 on ClinicalTrials.gov