NCT06398314 Palliative Radiotherapy in Symptomatic Pelvic Soft Tissue Tumors
| NCT ID | NCT06398314 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Sykehuset Telemark |
| Condition | Gastrointestinal Cancer |
| Study Type | INTERVENTIONAL |
| Enrollment | 200 participants |
| Start Date | 2024-12-10 |
| Primary Completion | 2029-12 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 200 participants in total. It began in 2024-12-10 with a primary completion date of 2029-12.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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.
Eligibility Criteria
Inclusion Criteria: * Patients unsuitable for curative treatment due to either advanced disease or medical contradictions (i.e comorbidity, old age, poor general condition) * Histologically verified primary cancer originated from gastrointestinal, urological or gynecological organs (histological verification can be performed on other lesions than the symptomatic pelvic tumor) * Primary, residual, recurrent or metastatic pelvic tumor from the above-mentioned cancers not amenable for curative treatment * Tumor-related symptoms including within the 5 defined categories pain, bleeding, bowel/lower urinary/vaginal dysfunction * Considered candidate for palliative radiotherapy according to both study arms * Patient reported severity of symptoms ≥4 on a NRS- scale of 0-10 * ≥18 years of age * Speaks and understands Norwegian or English * Ability to understand and willing to sign a written informed consent * ECOG performance status 0-3 * Expected survival \> 12 weeks * Able to pause systemic cancer treatment for one week prior to, during, and one week after the radiotherapy treatment * Women of childbearing potential (WOCBP) should have a negative highly sensitive serum pregnancy test within 72 hours prior to study intervention. WOCBP must agree to the use of highly effective birth control methods or abstain from heterosexual sexual activity from randomization and until completed study intervention Exclusion Criteria: * Neuroendocrine histology of any kind * Sarcoma or sarcomal components in the histology * Tumors that originate from bony metastases without a soft tissue component * Unable to comply with study questionnaires * Ongoing treatment with an investigational drug at inclusion * Planned inclusion in another interventional clinical trial within 4 weeks after radiotherapy * Patients who are pregnant due to risk of teratogenic and abortifacient effects of radiotherapy
Contact & Investigator
Harald Ragnum, MD,PhD
STUDY CHAIR
Telemark Hospital Trust
Frequently Asked Questions
Who can join the NCT06398314 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Gastrointestinal Cancer. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06398314 currently recruiting?
Yes, NCT06398314 is actively recruiting participants. Contact the research team at kjeski@sthf.no for enrollment information.
Where is the NCT06398314 trial being conducted?
This trial is being conducted at Ålesund, Norway, Bergen, Norway, Bodø, Norway, Drammen, Norway and 7 additional locations.
Who is sponsoring the NCT06398314 clinical trial?
NCT06398314 is sponsored by Sykehuset Telemark. The principal investigator is Harald Ragnum, MD,PhD at Telemark Hospital Trust. The trial plans to enroll 200 participants.
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