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Trial Title:
18FFDG PET/CT for Early Evaluation of Chemotherapy Efficacy in Metastatic Colic Adenocarcinoma
NCT ID:
NCT05531045
Condition:
Metastatic Colorectal Cancer
Conditions: Official terms:
Adenocarcinoma
Study type:
Observational
Overall status:
Not yet recruiting
Study design:
Time perspective:
Prospective
Intervention:
Intervention type:
Diagnostic Test
Intervention name:
PET/CT
Description:
FDG PET/CT assessed after 2 cycles of chemotherapy with PERCIST criteria
Arm group label:
Cohort
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).
Criteria for eligibility:
Study pop:
Population fo patients with metastic colo-rectal cancer eligible to first line
chemotherapy
Sampling method:
Non-Probability Sample
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
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
Hôpital Saint Louis
Address:
City:
Paris
Zip:
75010
Country:
France
Contact:
Last name:
Thomas Aparico, MD
Email:
thomas.aparico@aphp.fr
Start date:
September 2022
Completion date:
September 2027
Lead sponsor:
Agency:
Assistance Publique - Hôpitaux de Paris
Agency class:
Other
Source:
Assistance Publique - Hôpitaux de Paris
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05531045
