"Cancersensor" Chemotherapy

Institut National de la Santé Et de la Recherche Médicale, France

Status: Completed

Conditions: Metastatic Colorectal Cancer

Study type: Observational

Funder types: Other

Identifiers

NCT01693861

C11-59

2012-A00168-35 (Registry Identifier)

Details and patient eligibility

About

Observational, non randomized study aimed at measuring the effect of chemotherapy in the urinary concentrations of physiological modified nucleosides in 30 patients with metastatic colorectal cancer.

Enrollment: 16 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Histologically-confirmed metastatic colorectal cancer;
• 0 to 3 prior chemotherapy lines;
• Signed informed consent;
• Good understanding of the protocol and of the follow-up;
• Estimated life expectancy exceeding 3 months;
• At least one measurable metastatic lesion (RECIST criteria);
• Performance Status (WHO) of 0 to 2;
• Good haematological, hepatic and renal functions.

Exclusion criteria

• More than 2 surgical resections of metastases from colorectal cancer;
• Poor performance status (>2);
• Poor haematological, hepatic or renal functions;
• Uncontrolled chronic disease;
• Serious unhealed wound, ulcer or fracture within the previous month;
• Clinical or laboratory finding suggesting possible abnormalities in nucleosides urinary excretion;
• Pregnancy or breast-feeding during the previous month;
• Transmeridian trip of more than 4 time zones within the prior 2 weeks;
• Person with legal restriction to participate into clinical research, according to the current law in France.

Trial design

16 participants in 1 patient group

Patients

Description:

Patients with metastatic colorectal cancer treated with chemotherapy