18FFDG PET/CT for Early Evaluation of Chemotherapy Efficacy in Metastatic Colic Adenocarcinoma (TEP-PREDICT)

Assistance Publique - Hôpitaux de Paris

Status: Not yet enrolling

Conditions: Metastatic Colorectal Cancer

Treatments: Diagnostic Test: PET/CT

Study type: Observational

Funder types: Other

Identifiers

NCT05531045

APHP180576

Details and patient eligibility

About

The metastatic colo-rectal cancer (especially with hepatic metastatic lesions, but also peritoneal or pulmonary lesions) is a major public health issue, because of its frequency, the heavy treatments and the cost of new therapeutic molecules involved, in particular targeted therapies that can result in specific adverse events. The first-line treatment often consists of a polychemotherapy, which can be associated to a targeted therapy. According to the therapeutic response, patient condition and disease extent, some patients may benefit from prognosis-changing treatments such as surgery of metastases. However, the best morphological response is most of time evidenced after only 6 or 8 cycles of treatment, corresponding to 3 to 4 months. Therapeutic evaluation with FDG PET/CT is validated in several neoplasia (lymphoma, breast cancer). Data on FDG PET evaluation of colic cancer chemotherapy are currently insufficient to propose its use in the usual clinical setting. We thus are going to study the performance of early FDG PET therapeutic evaluation to predict response to first-line chemotherapy in patients with potentially resectable metastases. If early PET diagnostic performances prove satisfying, this approach could become of paramount importance to tailor therapeutic strategy for these patients, with the possibility of early modification of chemotherapy protocol, which is now possible thanks to the existence of therapeutic alternatives (chemotherapy intensification, replacement of oxaliptaine by irinotecan or conversely, replacement of an anti-EGFR by an anti-angiogenic or conversely).

Enrollment: 222 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Histologically proved colo-rectal cancer
• Measurable metastatic disease according to RECIST 1.1 criteria
• Metastases considered potentially resectable (for example : hepatic, nodular peritoneal, lung lesions...) by the multidisciplinary committee meeting
• ECOG≤2
• Patient candidate to a first-line chemotherapy± targeted therapy according to standard protocols : LV5FU2, FOLFOX, FOLFIRI, FOLFIRINOX +/- bévacizumab, aflibercept , cétuximab, panitumumab
• In case of metachrone metastasis, adjuvant chemotherapy stopped for more than 6 months before relapse diagnosis
• Predictable life expectancy of more than 6 months
• Signed informed consent
• Age > 18 years

Exclusion criteria

• Patient with another evolutive neoplastic disease
• Patient participating in another study evaluating an imaging technique using ionizing radiations
• Brain metastasis
• Absence of health insurance coverage
• Pregnant of breastfeeding woman
• Hypersensitivity to FDG or to one of the excipients of used specialty

Trial design

222 participants in 1 patient group

Cohort

Description:

FDG PET/CT assessed after 2 cycles of chemotherapy

Treatment:

Diagnostic Test: PET/CT