Palliative Radiotherapy in Symptomatic Pelvic Soft Tissue Tumors
PALLSOFT
1 other identifier
interventional
200
1 country
11
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Dec 2024
Longer than P75 for not_applicable
11 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
April 17, 2024
CompletedFirst Posted
Study publicly available on registry
May 3, 2024
CompletedStudy Start
First participant enrolled
December 10, 2024
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2029
ExpectedStudy Completion
Last participant's last visit for all outcomes
December 1, 2030
May 23, 2025
March 1, 2025
5 years
April 17, 2024
May 22, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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
12 weeks
Secondary Outcomes (2)
Physician-reported toxicities
52 weeks
Survival
2 years
Other Outcomes (6)
Patient-reported quality of life
12 weeks
Prognostic models
Baseline
Prognostic models
Baseline
- +3 more other outcomes
Study Arms (2)
1-2 fractions of 8 Gy (Gray)
ACTIVE COMPARATOR5 fractions of 5 Gy (Gray)
ACTIVE COMPARATORInterventions
Hypofractionated radiotherapy
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
- Patients who are pregnant due to risk of teratogenic and abortifacient effects of radiotherapy
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Sykehuset Telemarklead
- Nordlandssykehuset HFcollaborator
- Møre og Romsdal Hospital Trustcollaborator
- Helse Stavanger HFcollaborator
- Hospital of Southern Norway Trustcollaborator
- Oslo University Hospitalcollaborator
- Vestre Viken Hospital Trustcollaborator
- Sykehuset Innlandet HFcollaborator
- St. Olavs Hospitalcollaborator
- Haukeland University Hospitalcollaborator
- University Hospital of North Norwaycollaborator
- South-Eastern Norway Regional Health Authoritycollaborator
Study Sites (11)
Helse Møre og Romsdal
Ålesund, Norway
Haukeland universitetssykehus
Bergen, Norway
Nordlandssykehuset Bodø
Bodø, Norway
Vestre Viken HF
Drammen, Norway
Sykehuset Innlandet HF
Gjøvik, Norway
Sørlandet sykehus HF
Kristiansand, Norway
Oslo Universitetssykehus
Oslo, Norway
Sykehuset Telemark HF
Skien, Norway
Stavanger Universitetssykehus
Stavanger, Norway
Universitetssykehuset i Nord-Norge
Tromsø, Norway
St. Olavs Hospital HF
Trondheim, Norway
Related Publications (1)
Skipar 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: 40597814DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY CHAIR
Harald Ragnum, MD,PhD
Telemark Hospital Trust
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER GOV
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
April 17, 2024
First Posted
May 3, 2024
Study Start
December 10, 2024
Primary Completion (Estimated)
December 1, 2029
Study Completion (Estimated)
December 1, 2030
Last Updated
May 23, 2025
Record last verified: 2025-03
Data Sharing
- IPD Sharing
- Will not share