Clinical trial NCT00855946: Proteomic Approach Using Matrix-assisted Laser Desorption/Ionization Tandem Time-of-flight (MALDI-TOF/TOF) of Tumor Response in Rectal Carcinoma After Radiochemotherapy
Official title: Proteomic Approach Using Matrix-assisted Laser Desorption/Ionization Tandem Time-of-flight (MALDI-TOF/TOF) of Tumor Response in Rectal Carcinoma After Radiochemotherapy
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Rectal Adenocarcinoma
Keywords: tumor response
rectal adenocarcinoma
preoperative radiochemotherapy
Proteomic analysis
MALDI-TOF-TOF
rectal adenocarcinoma, tumor response after preoperative radiochemotherapy
Lead sponsor: University Hospital, Bordeaux
Sponsor class: OTHER
First posted: 2009-03-05
Enrollment: 46
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: patient with rectal carcinoma

Brief summary: 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: 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.

Eligibility criteria: 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

Primary outcomes:
measure: differential expression of early seric biomarkers between good and bad responders.
timeFrame: at inclusion and 24-48h after starting radiochemotherapy
Secondary outcomes:
measure: modifications of isolated biomarkers within presurgical period
timeFrame: at inclusion, 24-48h after initiation of radiochemotherapy, at the end of radiochemotherapy (6th week) and before surgery
Other outcomes:
Locations:
city: Bordeaux
country: France
facility: Laboratoire d'anatomie pathologique, University Hospital, Bordeaux
Study officials:
affiliation: University Hospital Bordeaux, France
name: Anne RULLIER, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: University Hospital Bordeaux, France
name: Paul PEREZ, MD
role: STUDY_CHAIR
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