Proteomic Approach Using Matrix-assisted Laser Desorption/Ionization Tandem Time-of-flight (MALDI-TOF/TOF) of Tumor Response in Rectal Carcinoma After Radiochemotherapy

Study Overview
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Brief Summary
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Treatment for locally-advanced rectal adenocarcinoma includes preoperative radiochemotherapy before surgery with total mesorectal excision in order to reduce tumor infiltration, facilitate oncologic surgery and improve survival. About fifty percent of these patients are good responders i.e. their tumor infiltration reduces in the rectal wall and regional lymph nodes in order to be graded ypT0 to T2 N0 after pathologic assessment (so called downstaging). At the opposite, bad responders (ypT3-4 and/or N+) are not sensitive to standard preoperative radiochemotherapy, and their survival is poor than good responders. Until now, response to preoperative radiochemotherapy cannot be anticipated before pathological assessment of surgical specimen. Proteomic analysis of sera from good and bad responders to preoperative radiochemotherapy could allow identification of early biomarkers of tumor response, and subsequently adaptation of treatment to increase preoperative treatment efficiency and survival in most patients.

Detailed Description
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Good or bad responders to preoperative radiochemotherapy for locally-advanced rectal adenocarcinoma cannot be anticipated before pathological assessment of rectal specimen. The purpose of this prospective monocentric study is to look for early seric biomarkers predictive of tumor response (good and bad responders) in patients treated by preoperative radiochemotherapy (45 Gy) for rectal adenocarcinoma using a proteomic approach. All patients with locally-advanced rectal adenocarcinoma will be enrolled. Sequential samples of sera will be collected before, during preoperative treatment and before surgery, and analysed using a MALDI-TOF-TOF method. Proteomic analysis will be correlated to pathological response in order to identify potential early biomarkers of tumor response.

Official Title
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Proteomic Approach Using Matrix-assisted Laser Desorption/Ionization Tandem Time-of-flight (MALDI-TOF/TOF) of Tumor Response in Rectal Carcinoma After Radiochemotherapy

Conditions
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Rectal Adenocarcinoma

Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: T3T4 or N+ M0 rectal carcinoma histologically-proven adenocarcinoma from 0 to 15 cm from the anal verge patient is at least 18 years of age ECOG performance status </= 2 Patient and doctor have signed informed consent Exclusion Criteria: Metastatic disease T1-T2 N0 rectal carcinoma Contra indication of radiotherapy or chemotherapy History of cancer Severe renal insufficiency Symptomatic cardiac or coronary insufficiency Patient included in a trial Previous radiotherapy or chemotherapy for this cancer No contraceptive treatment

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| differential expression of early seric biomarkers between good and bad responders. |  | at inclusion and 24-48h after starting radiochemotherapy | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| modifications of isolated biomarkers within presurgical period |  | at inclusion, 24-48h after initiation of radiochemotherapy, at the end of radiochemotherapy (6th week) and before surgery | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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tumor response, rectal adenocarcinoma, preoperative radiochemotherapy, Proteomic analysis, MALDI-TOF-TOF, rectal adenocarcinoma, tumor response after preoperative radiochemotherapy