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Gastrointestinal CancerPALLSOFTNCT06398314

Palliative Radiotherapy in Symptomatic Pelvic Soft Tissue Tumors

A study testing Palliative radiotherapy in people with Gastrointestinal Cancer and Urologic Cancer, run by Sykehuset Telemark at 11 sites in Norway.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial 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… Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
Palliative radiotherapy
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
200 participants
Where
11 sitesNorway
Study dates
10 Dec 2024to Dec 2030
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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
Show all 13Show fewer
  • ≥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

Who cannot join

  • 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

Trial locations and contacts

11 sites in 1 country. Contact the study team or a site near you to ask about taking part.

Kjersti Skipar, MD contact

+47 98444114

kjeski@sthf.no

Harald Ragnum, MD, PhD contact

+47 90792571

harrag@sthf.no

11 sites in 1 country

Norway11 sites, 11 recruiting

  • Helse Møre og Romsdal

    Ålesund

    Cecilie S Nordstrand

    Recruiting

  • Haukeland universitetssykehus

    Bergen

    Christian Ekanger, christian.ekanger@helse-bergen.no

    Recruiting

  • Nordlandssykehuset Bodø

    Bodø

    Carsten Nieder, carsten.Nieder@nordlandssykehuset.no

    Recruiting

  • Vestre Viken HF

    Drammen

    Elin Høie Østrem, Elin.Hoie.Ostrem@vestreviken.no

    Recruiting

  • Sykehuset Innlandet HF

    Gjøvik

    Liv-Ellen Giske, Liv.Ellen.Giske@sykehuset-innlandet.no

    Recruiting

  • Sørlandet sykehus HF

    Kristiansand

    Christoph Evers, Christoph.Evers@sshf.no

    Recruiting

  • Oslo Universitetssykehus

    Oslo

    Marianne G Guren, Marianne.Gronlie.Guren@ous-hf.no

    Recruiting

  • Sykehuset Telemark HF

    Skien

    Kjersti Skipar, kjeski@sthf.no

    Harald B Ragnum, Harrag@sthf.no

    Recruiting

  • Stavanger Universitetssykehus

    Stavanger

    Kjersti Ødegaard, kjersti.odegaard@sus.no

    Recruiting

  • Universitetssykehuset i Nord-Norge

    Tromsø

    Lise Balteskard, Lise.Balteskard@unn.no

    Recruiting

  • St. Olavs Hospital HF

    Trondheim

    Hanne Tøndel, Hanne.Tondel@stolav.no

    Recruiting

Other trials in Norway

About this study

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.

Read the 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.

Being tested
Palliative radiotherapy
Keywords
Palliative radiotherapy, Patient-reported outcomes, Gastrointestinal cancer, Urologic cancer, Gynecologic cancer, Tumor hypoxia
Medical subject headings
Gastrointestinal Neoplasms, Urologic Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Palliative radiotherapyRadiation

    Hypofractionated radiotherapy

Study groups in NCT06398314
Study groupRoleWhat they receive
1-2 fractions of 8 Gy (Gray)Active comparatorNot described
Receives: Radiation: Palliative radiotherapy
5 fractions of 5 Gy (Gray)Active comparatorNot described
Receives: Radiation: Palliative radiotherapy

What is being measured

The primary outcome is the main question the study is designed to answer.

  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

    Measured: 12 weeks

Secondary outcomes (2)

  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

    Measured: 52 weeks

  2. Survival

    Establish whether 1-2 fractions of 8 Gy is non-inferior to 5 fractions of 5 Gy with regards to overall survival

    Measured: 2 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted3 May 2024
  2. Study start10 Dec 2024
  3. Primary completionDec 2029 (estimated)
  4. Study completionDec 2030 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Model description
Non-inferiority, multicenter
Masking
None (open label)
Enrolment
200 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06398314
Sponsor's protocol ID
606316 (REK)
Acronym
PALLSOFT
Status last verified
Mar 2025
First submitted
17 Apr 2024
Last updated
23 May 2025
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • 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.

    PubMed 40597814

Questions about this trial

What is this clinical trial studying?

A study testing Palliative radiotherapy in people with Gastrointestinal Cancer and Urologic Cancer, run by Sykehuset Telemark at 11 sites in Norway.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 13 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 23 May 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 11 sites in Norway. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Kjersti Skipar, MD (+47 98444114, kjeski@sthf.no), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Patient-reported symptomatic effect (time frame: 12 weeks). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06398314, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 May 2025.

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