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

Rectal Adenocarcinoma Clinical Trial

— PROTEORECTUM  

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00855946
• Other study ID #: CHUBX - 2008/25
• Status: Completed
• Phase: N/A
• First received: March 4, 2009
• Last updated: May 7, 2013
• Start date: May 2009
• Est. completion date: May 2012

Study information

• Verified date: May 2013
• Source: University Hospital, Bordeaux
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: French Data Protection Authority
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 46
• Est. completion date: May 2012
• Est. primary completion date: May 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 80 Years

Eligibility

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

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Adenocarcinoma
• Rectal Adenocarcinoma
• Rectal Neoplasms

Locations

Country	Name	City	State
France	Laboratoire d'anatomie pathologique, University Hospital, Bordeaux	Bordeaux

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Bordeaux

Country where clinical trial is conducted

France, 

References & Publications (34)

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* Note: There are 34 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	differential expression of early seric biomarkers between good and bad responders.		at inclusion and 24-48h after starting radiochemotherapy	No
Secondary	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	No