Proteomic Approach Using Matrix-assisted Laser Desorption/Ionization Tandem Time-of-flight (MALDI-TOF/TOF) of Tumor Response in Rectal Carcinoma After Radiochemotherapy
NCT ID: NCT00855946
Last Updated: 2013-05-09
Study Results
Results pending
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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Recruitment Status
COMPLETED
Total Enrollment
46 participants
Study Classification
OBSERVATIONAL
Study Start Date
2009-05-31
Study Completion Date
2012-05-31
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.
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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.
Conditions
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Rectal Adenocarcinoma
Study Design
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Observational Model Type
COHORT
Study Time Perspective
PROSPECTIVE
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
* 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
* 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
Minimum Eligible Age
18 Years
Maximum Eligible Age
80 Years
Eligible Sex
ALL
Accepts Healthy Volunteers
No
Sponsors
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University Hospital, Bordeaux
OTHER
Sponsor Role
lead
Responsible Party
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Responsibility Role
SPONSOR
Principal Investigators
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Anne RULLIER, MD
Role: PRINCIPAL_INVESTIGATOR
University Hospital Bordeaux, France
Paul PEREZ, MD
Role: STUDY_CHAIR
University Hospital Bordeaux, France
Locations
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Laboratoire d'anatomie pathologique, University Hospital, Bordeaux
Bordeaux, , France
Site Status
Countries
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France
References
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Other Identifiers
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CHUBX - 2008/25
Identifier Type: -
Identifier Source: org_study_id
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