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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).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Cohort | FDG PET/CT assessed after 2 cycles of chemotherapy |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| PET/CT | Diagnostic Test | FDG PET/CT assessed after 2 cycles of chemotherapy with PERCIST criteria |
|
| Measure | Description | Time Frame |
|---|---|---|
| early metabolic response assessed by PERCIST criteria | 4 months |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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Population fo patients with metastic colo-rectal cancer eligible to first line chemotherapy
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Laetitia Vercellino, MD | Contact | +33142499411 | laetitia.vercellino@aphp.fr | |
| Lambert Jerome, MD | Contact | +33142494016 | jerome.lambert@u-paris.fr |
| Name | Affiliation | Role |
|---|---|---|
| Thomas Aparicio, MD | Assistance Publique - Hôpitaux de Paris | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hôpital Saint Louis | Paris | 75010 | France |
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| ID | Term |
|---|---|
| D015179 | Colorectal Neoplasms |
| ID | Term |
|---|---|
| D007414 | Intestinal Neoplasms |
| D005770 | Gastrointestinal Neoplasms |
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
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| ID | Term |
|---|---|
| D000072078 | Positron Emission Tomography Computed Tomography |
| ID | Term |
|---|---|
| D049268 | Positron-Emission Tomography |
| D014055 | Tomography, Emission-Computed |
| D007090 | Image Interpretation, Computer-Assisted |
| D003952 | Diagnostic Imaging |
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| 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 |
| D009369 | Neoplasms |
| D004066 | Digestive System Diseases |
| D005767 | Gastrointestinal Diseases |
| D003108 | Colonic Diseases |
| D007410 | Intestinal Diseases |
| D012002 | Rectal Diseases |
| D019937 | Diagnostic Techniques and Procedures |
| D003933 | Diagnosis |
| D014057 | Tomography, X-Ray Computed |
| D064847 | Multimodal Imaging |
| D011856 | Radiographic Image Enhancement |
| D007089 | Image Enhancement |
| D010781 | Photography |
| D011859 | Radiography |
| D014056 | Tomography, X-Ray |
| D011877 | Radionuclide Imaging |
| D014054 | Tomography |
| D003947 | Diagnostic Techniques, Radioisotope |