Palliative radiotherapy for pelvic soft tissue tumors

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• 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

Study contacts

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

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.