Hôpital Saint Louis
Paris, 75010, France
NCT Number: NCT05531045
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).
Trial opening soon.
Get Notified18 year and older
All sexes
Observational
Paris, 75010, France
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
FDG PET/CT assessed after 2 cycles of chemotherapy with PERCIST criteria
Time frame: 4 months
Time frame: at the end of first line chemotherapy, an average of 12 months
Time frame: at the end of first line chemotherapy, an average of 12 months
Time frame: Month 2
Time frame: 36 months
Time frame: 36 months
Time frame: 2 months
Time frame: 2 months
Time frame: 2 months
Time frame: 2 months
Contact information is provided by the study sponsor or research team.
Laetitia Vercellino, MD
CONTACT
Lambert Jerome, MD
CONTACT
Assistance Publique - Hôpitaux de Paris
Other
18F-FDG Positron Emission Tomography/Tomodensitometry for Early Evaluation of Chemotherapy Efficacy in Metastatic Colic Adenocarcinoma
Acronym: TEP-PREDICT
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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