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New treatment option for Gastrointestinal Cancer
Official title Palliative Radiotherapy in Symptomatic Pelvic Soft Tissue Tumors
ClinicalTrials.gov ID: NCT06398314
What this study is testing
- What it's testing
- 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.
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join 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...
- 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
You likely can't join 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
- Ongoing treatment with an investigational drug at inclusion
- Planned inclusion in another treatment clinical trial within 4 weeks after radiotherapy
See the full eligibility 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...
- 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 treatment clinical trial within 4 weeks after radiotherapy
- Patients who are pregnant due to risk of teratogenic and abortifacient effects of radiotherapy
The study team makes the final eligibility decision.
Where it's taking place
- Ålesund, Norway
- Bergen, Norway
- Bodø, Norway
- Drammen, Norway
- Gjøvik, Norway
- Kristiansand, Norway
- Oslo, Norway
- Skien, Norway
- Stavanger, Norway
- Tromsø, Norway
- Trondheim, Norway
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Ålesund, Norway; Bergen, Norway; Bodø, Norway; Drammen, Norway; Gjøvik, Norway; Kristiansand, Norway and 5 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.