18FFDG PET/CT for Early Evaluation of Chemotherapy Efficacy in Metastatic Colic Adenocarcinoma (TEP-PREDICT)

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

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).

Study Overview

• Status: Not yet recruiting
• Conditions: Metastatic Colorectal Cancer
• Intervention / Treatment: Diagnostic test: PET/CT

• Study Type: Observational
• Enrollment (Anticipated): 222

Contacts and Locations

• Study Contact: Name: Laetitia Vercellino, MD; Phone Number: +33142499411; Email: laetitia.vercellino@aphp.fr
• Study Contact Backup: Name: Lambert Jerome, MD; Phone Number: +33142494016; Email: jerome.lambert@u-paris.fr

Study Locations

• France
  • Paris, France, 75010
    • Hôpital Saint Louis
    • Contact: Thomas Aparico, MD; Email: thomas.aparico@aphp.fr

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Population fo patients with metastic colo-rectal cancer eligible to first line chemotherapy

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Cohort; FDG PET/CT assessed after 2 cycles of chemotherapy	Diagnostic test: PET/CT; FDG PET/CT assessed after 2 cycles of chemotherapy with PERCIST criteria

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
early metabolic response assessed by PERCIST criteria	4 months

Secondary Outcome Measures

Outcome Measure	Time Frame
Overall Survival	36 months
Progression Free Survival	36 months
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
Best morphological response during the course of first line chemotherapy	at the end of first line chemotherapy, an average of 12 months
percentage of cases where early metabolic response evaluation would have led to a modification of the therapeutic strategy/management	Month 2
ΔSUVmax (EORTC criteria) between Pre-therapeutic and 2 cycles PET assessment	2 months
ΔSULpeak (PERCIST criteria) between Pre-therapeutic and 2 cycles PET assessment	2 months
ΔMTV between Pre-therapeutic and 2 cycles PET assessment	2 months
ΔTLG between Pre-therapeutic and 2 cycles PET assessment	2 months

Collaborators and Investigators

• Sponsor: Assistance Publique - Hôpitaux de Paris
• Investigators: Study Director: Thomas Aparicio, MD, Assistance Publique - Hôpitaux de Paris

Study record dates

Study Major Dates

• Study Start (ANTICIPATED): September 1, 2022
• Primary Completion (ANTICIPATED): January 1, 2025
• Study Completion (ANTICIPATED): September 1, 2027

Study Registration Dates

• First Submitted: August 11, 2022
• First Submitted That Met QC Criteria: September 5, 2022
• First Posted (ACTUAL): September 7, 2022

Study Record Updates

• Last Update Posted (ACTUAL): September 7, 2022
• Last Update Submitted That Met QC Criteria: September 5, 2022
• Last Verified: August 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms by Histologic Type; Neoplasms; Carcinoma; Neoplasms, Glandular and Epithelial; Adenocarcinoma
• Other Study ID Numbers: APHP180576

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No