RandomizEd Controlled Trial for pre-operAtive dose-escaLation BOOST in locally advanced rectal cancer.

Completed

Conditions: rectal cancer.
rectal carcinoma
10017990
10017991

Registration Number: NL-OMON44829

Lead Sponsor: niversitair Medisch Centrum Utrecht

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Completed

Sex: Not specified

Target Recruitment: 142

Inclusion Criteria

* Participant in the PLCRC project (METC 12-510).
* Informed consent obtained for being offered experimental interventions within the PLCRC project.
* Informed consent obtained for questionnaires on patient reported outcomes within the PLCRC project.
* WHO: 0-2.
* T3+ (circumferential resection margin (CRM) positive) T4N0-1 or N2 M0-1 (if resectable liver and/or lung metastases).
* Referred for chemoradiation.
* No contra-indication for MRI.
* Tumor distance from ano-rectal transition *10cm.

Exclusion Criteria

* T3 (limited volume / CRM negative).
* Inflammatory bowel disease.
* Prior pelvic radiotherapy.
* At least one contra-indication for capecitabine administration (based on DPD-deficiency, blood count, liver malfunction, renal failure (Creatinine clearance <30ml/min, medical history such as recent cardiac events).
* Recent pregnancy *1 year ago.
* Inadequate understanding of the Dutch language in speech and/or writing.

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>The primary endpoint is complete response either defined as pathological<br /><br>complete response (pCR) in patients who undergo surgery, assessed by<br /><br>standardized pathologic examination of the surgical specimen, or 2-years local<br /><br>recurrence-free survival (LFRS) after chemoradiation in patients who opted for<br /><br>a wait and see approach. </p><br>

Secondary Outcome Measures

Name	Time	Method
<p>Secondary outcomes are treatment acute, perioperative and late toxicity, tumor<br /><br>response assessed with MRI, patient-reported quality of life and workability,<br /><br>local recurrence and (disease-specific) survival.</p><br>