Palliative Radiotherapy in Symptomatic Pelvic Soft Tissue Tumors

Launched by SYKEHUSET TELEMARK · May 2, 2024

Keywords

ClinConnect Summary

The PALLSOFT trial is studying the effects of palliative radiotherapy in patients with symptomatic pelvic soft tissue tumors caused by gastrointestinal, urological, or gynecological cancers. This trial aims to compare two treatment approaches: one that delivers radiotherapy in just 1-2 sessions and another that provides it over five sessions. The goal is to see if the fewer sessions are just as effective in reducing symptoms, such as pain and bleeding, while also looking at patients' quality of life and any potential side effects.

To participate, patients must be at least 18 years old and have a confirmed diagnosis of cancer that cannot be treated with curative methods due to advanced disease or other health issues. They should be experiencing significant symptoms and able to take a break from other cancer treatments for a short period. Participants can expect to receive either treatment option, complete questionnaires about their symptoms, and undergo assessments related to their overall health and wellbeing. It’s important to note that this study is currently recruiting participants and is focused on improving care for those facing challenging cancer-related issues.

Gender

ALL

Eligibility 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