Overview
Combined Therapy in Radiation Proctopathy
Status:
Completed
Completed
Trial end date:
2007-06-01
2007-06-01
Target enrollment:
0
0
Participant gender:
All
All
Summary
The aim of this study was to compare the efficacy and safety of two treatment regimens: argon plasma coagulation (APC) alone and APC in combination with sucralfate administered for chronic hemorrhagic radiation proctopathy.Phase:
Phase 4Accepts Healthy Volunteers?
NoDetails
Lead Sponsor:
Maria Sklodowska-Curie Institute - Oncology Center
Maria Sklodowska-Curie Memorial Cancer Center, Institute of OncologyCollaborator:
Medical Centre for Postgraduate EducationTreatments:
Sucralfate
Criteria
Inclusion Criteria:- radiotherapy due to pelvic tumors completed at least three months prior to enrollment
- presence of rectal bleeding
- radiation-induced telangiectasia in the rectum and/or sigmoid colon on endoscopy
- informed written consent to participate in the study
Exclusion Criteria:
- history of clinically significant rectal bleeding prior to radiotherapy
- conditions predisposing the patient to rectal bleeding including inflammatory bowel
disease, tumors of the large bowel, intestinal vascular lesions (other than
radiation-induced telangiectasia), and diversion of the fecal stream
- sucralfate treatment during the two weeks prior to enrollment
- renal insufficiency (creatinine level ≥2 mg/dl)
- concurrent chemotherapy
- concurrent therapy with tetracycline, fluoroquinolones, or antimycotic drugs (because
of drug interaction)
- concurrent therapy with oral anticoagulants