CompletedNot Applicable

Care of Cancer Patients With Bowel Injury Caused by Radiation Therapy to the Pelvis

United Kingdom250 participantsStarted 2007-04

Plain-language summary

RATIONALE: A step-by-step procedure may help health care practitioners diagnose and treat cancer patients with bowel injury symptoms caused by radiation therapy. PURPOSE: This randomized clinical trial is studying the care of cancer patients with bowel injury caused by radiation therapy to the pelvis.

Who can participate

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

DISEASE CHARACTERISTICS: * Has undergone radical pelvic radiotherapy with curative intent to the prostate, bladder, vulva, vagina, cervix, endometrium, anus, or rectum OR para-aortic irradiation for a tumor at any of these primary sites, including the testes, \> 6 months ago * Has new-onset, troublesome gastrointestinal symptoms that developed \> 6 months after completion of pelvic radiotherapy * Does not require immediate gastroenterological assessment, as deemed by the clinical oncologist * Recruited directly from radiotherapy follow-up clinics at the Royal Marsden Hospital PATIENT CHARACTERISTICS: * Life expectancy \> 1 year PRIOR CONCURRENT THERAPY: * See Disease Characteristics

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Improvement in gastrointestinal symptoms as measured by the modified IBDQ-B score, Rockwood Fecal Incontinence Quality of Life score, St Mark's Incontinence score, and the LENTSOMA score at baseline, 6 months, and 1 year

Trial details

NCT IDNCT00737230

SponsorRoyal Marsden NHS Foundation Trust

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2010-09

View on ClinicalTrials.gov More Cancer trials

Plain-language summary

Who can participate

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.