Study of Circulating Markers in Serum of Patients Treated for Metastatic Colorectal Cancer (Coca-Colon)

University Hospital, Rouen

Status: Completed

Conditions: Metastatic Colorectal Cancer

Treatments: Other: Blood sampling

Study type: Interventional

Funder types: Other

Identifiers

NCT01212510

2009/170/HP

Details and patient eligibility

About

The primary purpose of the study is to confirm the results of previous study about the usefulness of the serum Carcinoembryonic antigen (CEA) kinetic for chemotherapy monitoring in patients with unresectable metastasis of colorectal cancer (J Clin Oncol 2008;26:3681-6). The secondary purpose is to evaluate the value of circulating free mutant DNA and circulating tumor cells (CTC) and their variations during the treatment.

Full description

Prospective cohort study of patients treated with systemic chemotherapy for unresectable metastatic colorectal cancer. The chemotherapy monitoring is currently based on radiological evaluation (RECIST criteria) and clinical evaluation. Circulating markers as CEA, free mutant DNA, CTC represent an alternative approach. A previous study on usefulness of the serum Carcinoembryonic antigen (CEA) kinetic for chemotherapy monitoring in patients with unresectable metastasis of colorectal cancer has been published (J Clin Oncol 2008;26:3681-6). The present study is designed to validate the previous data. The secondary purpose is to evaluate variations of free mutant DNA and CTC during the chemotherapy. Patients will be included prospectively in 4 centers in Normandy. All systemic chemotherapy and biotherapy validate in this clinical situation by the French National Cancer Institute (INCa) is accepted. Evaluation of response based on RECIST criteria will be performed every 3 months. Blood samples for CEA and CA 19-9 levels will be performed every courses of chemotherapy during first 3 months. Blood samples for detection of free mutant DNA and CTC will be performed at day 1 and 42 of chemotherapy.

Enrollment: 200 patients

Sex: All

Ages: 18 to 95 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Patient has Stage IV colorectal adenocarcinoma histologically proved
• Patient has at least one measurable lesion
• Patient has performance status 0-2 on the WHO performance scale
• Patient is male or female, and > 18 years of age
• Patient has agree to participate by giving written informed consent

Exclusion criteria

• Patient has known psychiatric or substance abuse disorders that would interfere with cooperation with the requirements of the study.

Trial design

Primary purpose: Diagnostic

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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200 participants in 1 patient group

Tumor markers

Other group

Description:

measurement of tumor markers ( blood rate of ACE, CA19-9, circulating tumor cell, circulating tumor DNA )

Treatment:

Other: Blood sampling