NCT05531045Not yet recruiting
18FFDG PET/CT for Early Evaluation of Chemotherapy Efficacy in Metastatic Colic Adenocarcinoma
18F-FDG Positron Emission Tomography/Tomodensitometry for Early Evaluation of Chemotherapy Efficacy in Metastatic Colic Adenocarcinoma
Source: ClinicalTrials.gov · Last updated 7 Sept 2022 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
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).
- Status (registry)
- Not yet recruiting
- Study type
- Observational
- Enrollment
- 222 (estimated)
- First submitted
- 11 Aug 2022
- Start date
- Sept 2022
- Primary completion date
- Jan 2025
- Lead sponsor
- Assistance Publique - Hôpitaux de Paris
- Diseases
- Colorectal cancer
- NCT number
- NCT05531045
What you commit to
- Study type: Observational
- Planned participants: 222
- From Sept 2022 to the primary completion date, Jan 2025
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other illness
- Patient with another evolutive neoplastic disease
- Hypersensitivity to FDG or to one of the excipients of used specialty
Other
- Patient participating in another study evaluating an imaging technique using ionizing radiations
- Brain metastasis
- Absence of health insurance coverage
- Pregnant of breastfeeding woman
Who the study is looking for
- 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
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Hopital Saint Louis Coordinator of this site? Confirm its status | Paris | France | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.