18FFDG PET/CT for Early Evaluation of Chemotherapy Efficacy in Metastatic Colic Adenocarcinoma

Metastatic Colorectal Cancer Clinical Trial

— TEP-PREDICT  

Official title:

18F-FDG Positron Emission Tomography/Tomodensitometry for Early Evaluation of Chemotherapy Efficacy in Metastatic Colic Adenocarcinoma

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05531045
• Other study ID #: APHP180576
• Status: Not yet recruiting
• Start date: September 2022
• Est. completion date: September 2027

Study information

• Verified date: August 2022
• Source: Assistance Publique - Hôpitaux de Paris
• Contact: Laetitia Vercellino, MD
• Phone: +33142499411
• Email: laetitia.vercellino[@]aphp.fr
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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).

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 222
• Est. completion date: September 2027
• Est. primary completion date: January 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Adenocarcinoma
• Metastatic Colorectal Cancer

Intervention

Diagnostic Test:
• PET/CT
FDG PET/CT assessed after 2 cycles of chemotherapy with PERCIST criteria

Locations

Country	Name	City	State
France	Hôpital Saint Louis	Paris

Sponsors (1)

Lead Sponsor	Collaborator
Assistance Publique - Hôpitaux de Paris

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	early metabolic response assessed by PERCIST criteria		4 months
Secondary	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
Secondary	Best morphological response during the course of first line chemotherapy		at the end of first line chemotherapy, an average of 12 months
Secondary	percentage of cases where early metabolic response evaluation would have led to a modification of the therapeutic strategy/management		Month 2
Secondary	Progression Free Survival		36 months
Secondary	Overall Survival		36 months
Secondary	?SUVmax (EORTC criteria) between Pre-therapeutic and 2 cycles PET assessment		2 months
Secondary	?SULpeak (PERCIST criteria) between Pre-therapeutic and 2 cycles PET assessment		2 months
Secondary	?MTV between Pre-therapeutic and 2 cycles PET assessment		2 months
Secondary	?TLG between Pre-therapeutic and 2 cycles PET assessment		2 months