18FFDG PET/CT for Early Evaluation of Chemotherapy Efficacy in Metastatic Colic Adenocarcinoma

Study Overview
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Brief Summary
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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).

Official Title
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18F-FDG Positron Emission Tomography/Tomodensitometry for Early Evaluation of Chemotherapy Efficacy in Metastatic Colic Adenocarcinoma

Conditions
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Metastatic Colorectal Cancer

Intervention / Treatment
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* Diagnostic Test: PET/CT


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Cohort<br>FDG PET/CT assessed after 2 cycles of chemotherapy | Diagnostic Test: PET/CT<br>* FDG PET/CT assessed after 2 cycles of chemotherapy with PERCIST criteria<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| early metabolic response assessed by PERCIST criteria |  | 4 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Resection of metastases defined by a R0 or R1 resection (macroscopically complete surgery with disease-free margins or minimal residual disease) after the end of first line chemotherapy |  | at the end of first line chemotherapy, an average of 12 months | 
| Best morphological response during the course of first line chemotherapy |  | at the end of first line chemotherapy, an average of 12 months | 
| percentage of cases where early metabolic response evaluation would have led to a modification of the therapeutic strategy/management |  | Month 2 | 
| Progression Free Survival |  | 36 months | 
| Overall Survival |  | 36 months | 
| ΔSUVmax (EORTC criteria) between Pre-therapeutic and 2 cycles PET assessment |  | 2 months | 
| ΔSULpeak (PERCIST criteria) between Pre-therapeutic and 2 cycles PET assessment |  | 2 months | 
| ΔMTV between Pre-therapeutic and 2 cycles PET assessment |  | 2 months | 
| ΔTLG between Pre-therapeutic and 2 cycles PET assessment |  | 2 months |