Thalidomide in the Treatment of Chronic Radiation Proctitis With Intractable Bleeding (NCT04680195) | Clinical Trial Compass
UnknownPhase 2
Thalidomide in the Treatment of Chronic Radiation Proctitis With Intractable Bleeding
62 participantsStarted 2020-12-14
Plain-language summary
Chronic radiation proctitis (CRP) is the main secondary toxic injury after pelvic radiotherapy. Hematochezia is the most common symptom for more than 80% of CRP patients.
Non-surgical treatment is the first choice to the treatment of CRP to avoid the occurrence of serious complications. Conventional oral medication for the treatment of bleeding CRP is very few and has little effect. At present, no oral medication has been found to significantly alleviate and control refractory bleeding of CRP. Therefore, it is an urgent problem to screen out a drug that is more effective, safe and highly compliant for the treatment of hemorrhagic CRP.
Thalidomide has anti-inflammatory, immune regulation, anti-angiogenesis and other effects. For the patients of CRP with intractable bleeding, a prospective, open clinical trial will be carried out to observe the safety and effectiveness of thalidomide in treating hemorrhagic CRP.
Who can participate
Age range
18 Years – 75 Years
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
. Patients aged 18-75 years;
. Patients with ECOG physical condition score of 0-2;
. Patients with previous pathological diagnosis of pelvic tumors (Gynecology, prostate, urinary system);
. Patients with a history of pelvic radiotherapy, at least 6 months from the end of the last radiotherapy;
. Patients with no primary tumor recurrence or metastasis;
. Patients with refractory hemorrhagic CRP who have failed to conventional treatment (SOMA score for hematochezia≥2, hemoglobin level ≤90g/L, or a history of blood transfusion due to CRP)
. Subjects and their family members can understand the research plan, and are willing to participate, and sign an informed consent form.
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
Remission rate of rectal bleeding one month after thalidomide treatment
Timeframe: the first month after thalidomide treatment
Trial details
NCT IDNCT04680195
SponsorSixth Affiliated Hospital, Sun Yat-sen University
. Patients with active bleeding requiring emergency treatment;
. Patients with severe complications of CRP, such as Rectal ulcer (VRS\>Grade 3) or fistula, perforation, stenosis, necrosis, perianal intractable pain and so on
. Patients with a history of rectal resection;
. Other bleeding diseases, such as grade III or IV hemorrhoids, coagulation dysfunction, etc.;
. Patients with other diseases requiring long-term use of anticoagulant drugs;