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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 (PROTEORECTUM)

U

University Hospital of Bordeaux

Status

Completed

Conditions

Rectal Adenocarcinoma

Study type

Observational

Funder types

Other

Identifiers

NCT00855946
CHUBX - 2008/25

Details and patient eligibility

About

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.

Full 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.

Enrollment

46 patients

Sex

All

Ages

18 to 80 years old

Volunteers

No 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

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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