An interventional study of Palliative radiotherapy in Gastrointestinal Cancer, Urologic Cancer and Gynecologic Cancer, sponsored by Sykehuset Telemark. Recruiting at 11 sites in Norway. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-05-23.
Sponsored by Sykehuset Telemark · Not applicable, Interventional, and Treatment
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.
Studies and clinical practice have proven palliative radiotherapy to provide efficient symptom relief in patients with symptomatic pelvic soft tissue tumors. However, studies are mainly retrospective, are difficult to compare due to a variety of radiotherapy fractionation schedules used, and lack data on patient-reported quality of life. Consequently, no recommended standard of care is established, and several schedules are employed with variations in both number of fractions and total radiation dose (measured in Gray=Gy). Given the limited life expectancy of palliative patients, a short-course radiotherapy schedule would be preferable provided efficient symptom relief and good health-related quality of life.
PALLSOFT is a national, randomized, non-inferiority study that will investigate whether the symptomatic effect of a short-course radiotherapy schedule of 8 Gy x 1-2 is non-inferior to a more prolonged schedule of 5 Gy x 5. The study will include patients with symptomatic pelvic soft tissue tumors from either gastrointestinal, urological or gynecological cancer. Patients will defined a target symptom from 5 predefined cathegories (pain, bleeding, bowel/lower urinary tract/vaginal dysfunction), and change in symptom intensity will be assessed, as well as overall toxicities, quality of life and survival. Prognostic and predictive biomarkers will be explores, the latter with particular emphasis on the significance of tumor hypoxia in palliative radiotherapy.
779 studies on the registry are indexed under Gastrointestinal Neoplasms; 230 are open to participants now.
This study's planned enrollment of 200 is above the median of 61 across 568 interventional studies indexed under Gastrointestinal Neoplasms.
Browse Gastrointestinal Neoplasms studies →Sykehuset Telemark is the lead sponsor of 32 studies on the registry; 5 are open to participants now.
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Exclusion Criteria:
Radiation: Palliative radiotherapy
Radiation: Palliative radiotherapy
Hypofractionated radiotherapy
Patient-reported symptomatic effect
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
Time frame: 12 weeks
Physician-reported toxicities
Establish whether 1-2 fractions of 8 Gy is non-inferior to 5 fractions of 5 Gy with regards to bladder and bowel toxicities assessed by CTCAE
Time frame: 52 weeks
Survival
Establish whether 1-2 fractions of 8 Gy is non-inferior to 5 fractions of 5 Gy with regards to overall survival
Time frame: 2 years
Patient-reported quality of life
Establish whether 1-2 fractions of 8 Gy is non-inferior to 5 fractions of 5 Gy with regards to quality of life assessed by EORTC-QLQ C15PAL (European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire Core15 Palliative)
Time frame: 12 weeks
Prognostic models
Explore prognostic models for patient classification: Glasgow Prognostic Score (GPS): C-Reactive Protein (CRP, mg/L), Albumin (g/L) GPS 0 = Normal level CRP and albumin GPS 1: Increased CRP or low albumin GPS 2: Increased CRP and low albumin
Time frame: Baseline
Prognostic models
Explore prognostic models for patient classification: LabBM: CRP (mg/L), LDH (lactate dehydrogenase, U/L), Albumin (g/L), hemoglobin (g/dL), platelets (E09/L) The score is calculated as follows; CRP and LDH above upper limit of normal=1 point for each parameter. Albumin, hemoglobin and platelets below the lower limit of normal: 0.5 point for each parameter. Minimum score 0 point, maximum score 3.5 points. Low score indicates a more favorable prognosis
Time frame: Baseline
Prognostic models
Explore prognostic models for patient classification: LabPS: CRP (mg/L), LDH (lactate dehydrogenase, U/L), Albumin (g/L), hemoglobin (g/dL), platelets (E09/L), Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) The score is calculated as follows; CRP and LDH above upper limit of normal=1 point for each parameter. Albumin, hemoglobin and platelets below the lower limit of normal: 0.5 point for each parameter. ECOG PS 3-4, 2 and 0-1: 1, 0.5 and 0 points,respectively Minimum score 0 point, maximum score 4.5 points. Low score indicates a more favorable prognosis
Time frame: Baseline
Predictive biomarkers MRI
Magnetic Resonance Images (MRI) previously acquired for diagnosis, treatment and/or follow up will be collected. Hypoxia images will be generated using the Consumption and Supply- based Hypoxia (CSH) Imaging Method. The tumor hypoxic fraction (HF) will be calculated on hypoxia images and explored as a potential explanatory response variable in individual patients.
Time frame: Baseline
Predictive biomarkers tumor biopsies
Tumor biopsies previously acquired for diagnosis, treatment and/or follow up will be collected. Tumor RNA will be isolated from paraffin embedded tissue blocks, subjected to global gene expression analysis and used to indicate hypoxia by applying previously established gene signatures. Gene signatures will be explored as potential explanatory response variable in individual patients.
Time frame: Baseline
Plan to share: No
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Sykehuset Telemark