Palliative Short-Course Radiotherapy in Rectal Cancer (NCT02639403) | Clinical Trial Compass
CompletedPhase 2
Palliative Short-Course Radiotherapy in Rectal Cancer
18 participantsStarted 2003-10
Plain-language summary
Radiotherapy (RT) is a potentially effective method in the treatment of symptoms of rectal carcinomas. Nevertheless, almost all the evidences about palliative RT in rectal cancer have been published more than two decades ago and were based on 2D conventional RT, which is nowadays no longer used. Consequently, prospective studies on the efficacy of 3D-RT in the management of symptomatic rectal cancer are still lacking. The aim of this prospective study was to assess the efficacy of palliative short-course 3D RT (SCRT) in patients with symptomatic obstructive rectal cancer.
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.
Inclusion Criteria:
* (i) rectal adenocarcinoma with obstructive symptoms not amenable for curative treatment due to synchronous metastases or patient inoperable due to age and/or comorbidities;
* (ii) symptoms of colorectal obstruction (progressive constipation with abdominal pain arising from less than 2 months, vomiting and/or diarrhea) and/or signs of obstruction at radiological examinations (presence of air-fluid levels or the presence of distended colon upstream neoplastic stenosis of the rectum);
* (iii) candidates for derivative colostomy;
* (iv) bi-dimensionally measurable disease;
* (v) Eastern Cooperative Oncology Group (ECOG) performance status of 0-3;
* (vi) able to provide a written informed consent.
Exclusion Criteria:
* (i) RT within 6 months in the same anatomical area before the initiation of study treatment;
* (ii) clinically detectable ascites;
* (iii) pregnancy
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
1
Change of the obstructive symptoms
Timeframe: Clinical evaluation was performed before commencement of RT, 4 weeks after the end of treatment and every 6 months until the established length of follow up (3 years) or death.
Trial details
NCT IDNCT02639403
SponsorIRCCS Azienda Ospedaliero-Universitaria di Bologna