Palliative Radiotherapy in Symptomatic Pelvic Soft Tissue Tumors
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorSykehuset Telemark
About this trial
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
Qualifiers
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
Disqualifiers
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
Trial design
Treatments tested in this trial
- Palliative radiotherapy
Treatment groups
200 Participants
are divided into 2 treatment groupsSponsors and collaborators
Sykehuset Telemark
Lead sponsor
Nordlandssykehuset HF
Collaborator
Møre og Romsdal Hospital Trust
Collaborator
Helse Stavanger HF
Collaborator
Hospital of Southern Norway Trust
Collaborator
Oslo University Hospital
Collaborator
Vestre Viken Hospital Trust
Collaborator
Sykehuset Innlandet HF
Collaborator
St. Olavs Hospital
Collaborator
Haukeland University Hospital
Collaborator
University Hospital of North Norway
Collaborator
South-Eastern Norway Regional Health Authority
Collaborator
Source ClinicalTrials.gov