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

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT00855946

Acronym

PROTEORECTUM

Enrollment

Registered

2009-03-05

Start date

2009-05-31

Completion date

2012-05-31

Last updated

2013-05-09

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Rectal Adenocarcinoma

Keywords

tumor response, rectal adenocarcinoma, preoperative radiochemotherapy, Proteomic analysis, MALDI-TOF-TOF, rectal adenocarcinoma, tumor response after preoperative radiochemotherapy

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.

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to 80 Years

Healthy volunteers

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

Design outcomes

Primary

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

Secondary

Measure	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

Countries

France

Outcome results