Feasibility study of external beam radiation therapy followed by high-dose rate endorectal brachytherapy (HDRBT) in inoperable rectal cancer patients

Phase 2

Not yet recruiting

Conditions: rectal cancer
bowel cancer
10017990
10017991

Registration Number: NL-OMON30965

Lead Sponsor: Antoni van Leeuwenhoek Ziekenhuis

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Pending

Sex: Not specified

Target Recruitment: 20

Inclusion Criteria

-Histologically verified adenocarcinoma of the rectum within 15 cm of the anal verge, <= 2/3 of the rectal circumferential diameter
-cT2-4N0-1M0-1; in patients with M1 disease, life expectancy is >= 6 months
-Patients who are unfit for surgical treatment, due to co-morbidity, or patients who refuse surgery
-WHO <= 2

Exclusion Criteria

-Pregnant women
-Patients with any psychological, familial, sociological or geographical condition potentially hampering compliance with the study protocol and follow-up schedule; those conditions should be discussed with the patient before registration in the trial

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>To determine the feasibility and the maximum tolerated radiation dose in HDRBT<br /><br>of the rectum after EBRT in rectal cancer patients who are unfit for surgery or<br /><br>refuse surgery</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>To determine the incidence and severity of acute and late toxicity of EBRT<br /><br>followed by HDRBT<br /><br>To determine the patients sphincter function<br /><br>To determine the clinical tumor response of EBRT followed by HDRBT<br /><br>*To correlate the isodose lines of the irradiated tumor and normal tissue<br /><br>volumes with toxicity (HDRBT)</p><br>