Status:
UNKNOWN
Thalidomide in the Treatment of Chronic Radiation Proctitis With Intractable Bleeding
Lead Sponsor:
Sixth Affiliated Hospital, Sun Yat-sen University
Conditions:
Chronic Radiation Proctitis
Eligibility:
All Genders
18-75 years
Phase:
PHASE2
Brief 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 th...
Detailed Description
Radiotherapy is an essential therapeutic tool for pelvic malignancies such as uterine cervix, uterine corpus, prostate, testicular, urinary bladder and rectal cancers. According to reports, the estima...
Eligibility Criteria
Inclusion
- 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.
- Exclusion Criteria:
- 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;
- Combined intestinal obstruction, requiring surgery;
- The absolute value of neutrophils of patients is lower than 750/mm3;
- Patients who are allergic to thalidomide;
- Pregnant or lactating women;
- Patients with severe mental illness;
- Patients who cannot take medication or follow up as planned;
- During the trial and within 3 months after the trial, the subjects and their partners are not willing to contraception;
- Participants in other clinical investigators 3 months before the trial
Exclusion
Key Trial Info
Start Date :
December 14 2020
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 30 2022
Estimated Enrollment :
62 Patients enrolled
Trial Details
Trial ID
NCT04680195
Start Date
December 14 2020
End Date
December 30 2022
Last Update
December 22 2020
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