Palliative radiotherapy for pelvic soft tissue tumors
Palliative Radiotherapy in Symptomatic Pelvic Soft Tissue Tumors
This study is testing if giving fewer doses of palliative radiotherapy can help relieve symptoms and improve quality of life for patients with pelvic soft tissue tumors from gastrointestinal, urological, or gynecological cancers.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 200 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Sykehuset Telemark Government |
| Drugs / interventions | radiation |
| Locations | 11 sites (Ålesund and 10 other locations) |
| Trial ID | NCT06398314 on ClinicalTrials.gov |
What this trial studies
This trial investigates the effectiveness of palliative radiotherapy delivered in 1-2 fractions compared to a standard 5-fraction schedule for patients with symptomatic pelvic soft tissue tumors from gastrointestinal, urological, or gynecological cancers. It aims to assess patient-reported outcomes, including symptom relief, quality of life, and overall toxicities. The study will also explore prognostic and predictive biomarkers, particularly focusing on tumor hypoxia. By comparing these two treatment schedules, the trial seeks to establish a more efficient approach to palliative care in this patient population.
Who should consider this trial
Good fit: Ideal candidates include adults with advanced gastrointestinal, urological, or gynecological cancers who are experiencing significant tumor-related symptoms and are unsuitable for curative treatment.
Not a fit: Patients with early-stage cancers or those who are candidates for curative treatment may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide a more effective and shorter treatment option for patients suffering from pelvic soft tissue tumors.
How similar studies have performed: Previous studies have shown the effectiveness of palliative radiotherapy, but this specific approach comparing fractionation schedules is novel.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
Ålesund and 10 other locations
- Helse Møre og Romsdal — Ålesund, Norway (Recruiting)
- Haukeland universitetssykehus — Bergen, Norway (Recruiting)
- Nordlandssykehuset Bodø — Bodø, Norway (Recruiting)
- Vestre Viken HF — Drammen, Norway (Recruiting)
- Sykehuset Innlandet HF — Gjøvik, Norway (Recruiting)
- Sørlandet sykehus HF — Kristiansand, Norway (Recruiting)
- Oslo Universitetssykehus — Oslo, Norway (Recruiting)
- Sykehuset Telemark HF — Skien, Norway (Recruiting)
- Stavanger Universitetssykehus — Stavanger, Norway (Recruiting)
- Universitetssykehuset i Nord-Norge — Tromsø, Norway (Recruiting)
- St. Olavs Hospital HF — Trondheim, Norway (Recruiting)
Study contacts
- Study coordinator: Kjersti Skipar, MD
- Email: kjeski@sthf.no
- Phone: +47 98444114
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.