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
This trial does not accept healthy volunteersQualifiers
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
Design model
Parallel
Treatments tested in this trial
Palliative radiotherapy
RadiationHypofractionated radiotherapy
Treatment groups
200 Participants
are divided into 2 treatment groupsGroup A: 1-2 fractions of 8 Gy (Gray)Active comparator 1 intervention
Group B: 5 fractions of 5 Gy (Gray)Active comparator 1 intervention
Trial outcomes
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
Time frame
12 weeksSecondary outcomes
1
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 weeks2
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 yearsOther outcomes
1
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 weeks2
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
Baseline3
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
Baseline4
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
BaselineSponsors and contacts
Click on the lead sponsor to view all of their trials.
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