Actively Recruiting
Palliative Radiotherapy in Symptomatic Pelvic Soft Tissue Tumors
Led by Sykehuset Telemark · Updated on 2025-05-23
200
Participants Needed
11
Research Sites
311 weeks
Total Duration
On this page
Sponsors
S
Sykehuset Telemark
Lead Sponsor
N
Nordlandssykehuset HF
Collaborating Sponsor
AI-Summary
What this Trial Is About
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
Official Title
Palliative Radiotherapy in Symptomatic Pelvic Soft Tissue Tumors
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patients unsuitable for curative treatment due to advanced disease or medical contraindications such as comorbidity, old age, or poor general condition
- Histologically verified primary cancer from gastrointestinal, urological, or gynecological organs
- Primary, residual, recurrent, or metastatic pelvic tumor from the above cancers not suitable for curative treatment
- Presence of tumor-related symptoms including pain, bleeding, bowel, lower urinary, or vaginal dysfunction
- Candidate for palliative radiotherapy according to both study arms
- Patient-reported symptom severity of 4 or higher on a 0-10 numeric rating scale
- Age 18 years or older
- Speaks and understands Norwegian or English
- Able to understand and willing to sign written informed consent
- ECOG performance status between 0 and 3
- Expected survival longer than 12 weeks
- Able to pause systemic cancer treatment one week before, during, and one week after radiotherapy
- Women of childbearing potential must have a negative serum pregnancy test within 72 hours before treatment and agree to use highly effective contraception or abstain from heterosexual sex from randomization until study completion
You will not qualify if you...
- Neuroendocrine histology of any kind
- Sarcoma or sarcomal components in the tumor histology
- Tumors originating from bone metastases without soft tissue component
- Unable to comply with study questionnaires
- Receiving investigational drug treatment at inclusion
- Planned participation in another interventional clinical trial within 4 weeks after radiotherapy
- Pregnancy due to risks of teratogenic and abortifacient effects of radiotherapy
AI-Screening
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Trial Site Locations
Total: 11 locations
1
Helse Møre og Romsdal
Ålesund, Norway
Actively Recruiting
2
Haukeland universitetssykehus
Bergen, Norway
Actively Recruiting
3
Nordlandssykehuset Bodø
Bodø, Norway
Actively Recruiting
4
Vestre Viken HF
Drammen, Norway
Actively Recruiting
5
Sykehuset Innlandet HF
Gjøvik, Norway
Actively Recruiting
6
Sørlandet sykehus HF
Kristiansand, Norway
Actively Recruiting
7
Oslo Universitetssykehus
Oslo, Norway
Actively Recruiting
8
Sykehuset Telemark HF
Skien, Norway
Actively Recruiting
9
Stavanger Universitetssykehus
Stavanger, Norway
Actively Recruiting
10
Universitetssykehuset i Nord-Norge
Tromsø, Norway
Actively Recruiting
11
St. Olavs Hospital HF
Trondheim, Norway
Actively Recruiting
Research Team
K
Kjersti Skipar, MD
CONTACT
H
Harald Ragnum, MD, PhD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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