Palliative Radiotherapy in Symptomatic Pelvic Soft Tissue Tumors (PALLSOFT)

May 22, 2025 updated by: Sykehuset Telemark
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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

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.

Study Type

Interventional

Enrollment (Estimated)

200

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

  • Name: Kjersti Skipar, MD
  • Phone Number: +47 98444114
  • Email: kjeski@sthf.no

Study Contact Backup

  • Name: Harald Ragnum, MD, PhD
  • Phone Number: +47 90792571
  • Email: harrag@sthf.no

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: 1-2 fractions of 8 Gy (Gray)
Radiation: Palliative radiotherapy
Hypofractionated radiotherapy
Active Comparator: 5 fractions of 5 Gy (Gray)
Radiation: Palliative radiotherapy
Hypofractionated radiotherapy

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Patient-reported symptomatic effect
Time Frame: 12 weeks
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Physician-reported toxicities
Time Frame: 52 weeks
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
52 weeks
Survival
Time Frame: 2 years
Establish whether 1-2 fractions of 8 Gy is non-inferior to 5 fractions of 5 Gy with regards to overall survival
2 years

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Patient-reported quality of life
Time Frame: 12 weeks
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)
12 weeks
Prognostic models
Time Frame: Baseline

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
Baseline
Prognostic models
Time Frame: Baseline

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
Baseline
Prognostic models
Time Frame: Baseline

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
Baseline
Predictive biomarkers MRI
Time Frame: Baseline
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.
Baseline
Predictive biomarkers tumor biopsies
Time Frame: Baseline
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.
Baseline

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sykehuset Telemark

Collaborators

Vestre Viken Hospital Trust
Oslo University Hospital
University Hospital of North Norway
Helse Stavanger HF
Haukeland University Hospital
St. Olavs Hospital
Sykehuset Innlandet HF
Møre og Romsdal Hospital Trust
Nordlandssykehuset HF
South-Eastern Norway Regional Health Authority
Hospital of Southern Norway Trust

Investigators

  • Study Chair: Harald Ragnum, MD,PhD, Telemark Hospital Trust

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 10, 2024

Primary Completion (Estimated)

December 1, 2029

Study Completion (Estimated)

December 1, 2030

Study Registration Dates

First Submitted

April 17, 2024

First Submitted That Met QC Criteria

May 2, 2024

First Posted (Actual)

May 3, 2024

Study Record Updates

Last Update Posted (Actual)

May 23, 2025

Last Update Submitted That Met QC Criteria

May 22, 2025

Last Verified

March 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 606316 (REK)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Gynecologic Cancer

Clinical Trials on Palliative radiotherapy

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Mauritius

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe