Clinical trial · Interventional
Palliative Radiotherapy in Symptomatic Pelvic Soft Tissue Tumors
NCT06398314CI-TRIAL-00090103PALLSOFTrecruitingN/AClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (3)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Gastrointestinal Cancer | Malignant Digestive System Neoplasm | ALIAS | 0.90 |
| Gynecologic Cancer | Malignant Female Reproductive System Neoplasm | ALIAS | 0.90 |
| Urologic Cancer | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Palliative radiotherapy | Radiation | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- ACTIVE_COMPARATOR
- label
- 1-2 fractions of 8 Gy (Gray)
- interventionNames
- Radiation: Palliative radiotherapy
- type
- ACTIVE_COMPARATOR
- label
- 5 fractions of 5 Gy (Gray)
- interventionNames
- Radiation: Palliative radiotherapy
Primary outcomes (1)
- measure
- Patient-reported symptomatic effect
- timeFrame
- 12 weeks
- description
- Establish whether 1-2 fractions of 8 Gy is non-inferior to 5 fractions of 5 Gy with regards to target symptom effect assessed by change in NRS 0-10 (Numerical Rating Scale) from baseline
Secondary outcomes (2)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (1)
- DERIVEDSkipar K, Orvik MS, Evers C, Balteskard L, Ekanger C, Giske LE, Odegaard K, Ostrem EH, Nordstrand CS, Tondel H, Nieder C, Guren MG, Kaasa S, Ragnum HB. Palliative radiotherapy in symptomatic pelvic soft tissue tumors (PallSoft)- protocol for a national, randomized, non-inferiority study. BMC Cancer. 2025 Jul 1;25(1):1051. doi: 10.1186/s12885-025-14424-1. PMID 40597814