Clinical trial NCT05531045: 18FFDG PET/CT for Early Evaluation of Chemotherapy Efficacy in Metastatic Colic Adenocarcinoma
Official title: 18F-FDG Positron Emission Tomography/Tomodensitometry for Early Evaluation of Chemotherapy Efficacy in Metastatic Colic Adenocarcinoma
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Metastatic Colorectal Cancer
Lead sponsor: Assistance Publique - Hôpitaux de Paris
Sponsor class: OTHER
First posted: 2022-09-07
Enrollment: 222
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Population fo patients with metastic colo-rectal cancer eligible to first line chemotherapy

Brief summary: 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).


Eligibility criteria: 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

Primary outcomes:
measure: early metabolic response assessed by PERCIST criteria
timeFrame: 4 months
Secondary outcomes:
measure: 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
timeFrame: at the end of first line chemotherapy, an average of 12 months
measure: Best morphological response during the course of first line chemotherapy
timeFrame: at the end of first line chemotherapy, an average of 12 months
measure: percentage of cases where early metabolic response evaluation would have led to a modification of the therapeutic strategy/management
timeFrame: Month 2
measure: Progression Free Survival
timeFrame: 36 months
measure: Overall Survival
timeFrame: 36 months
measure: ΔSUVmax (EORTC criteria) between Pre-therapeutic and 2 cycles PET assessment
timeFrame: 2 months
measure: ΔSULpeak (PERCIST criteria) between Pre-therapeutic and 2 cycles PET assessment
timeFrame: 2 months
measure: ΔMTV between Pre-therapeutic and 2 cycles PET assessment
timeFrame: 2 months
measure: ΔTLG between Pre-therapeutic and 2 cycles PET assessment
timeFrame: 2 months
Other outcomes:
Locations:
city: Paris
country: France
facility: Hôpital Saint Louis
Study officials:
affiliation: Assistance Publique - Hôpitaux de Paris
name: Thomas Aparicio, MD
role: STUDY_DIRECTOR
References: