Overview

Combined Therapy in Radiation Proctopathy

Status:
Completed
Trial end date:
2007-06-01
Target enrollment:
0
Participant gender:
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 4
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Maria Sklodowska-Curie Institute - Oncology Center
Maria Sklodowska-Curie Memorial Cancer Center, Institute of Oncology
Collaborator:
Medical Centre for Postgraduate Education
Treatments:
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