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

NCT05531045 | Not Yet Recruiting

• 1 other identifier: APHP180576
• Study Type: observational
• Target: 222
• Locations: 1 country
• Sites: 1

Brief 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).

Conditions

Metastatic Colorectal Cancer

Outcome Measures

Primary Outcomes (1)

• early metabolic response assessed by PERCIST criteria

  4 months

Secondary Outcomes (9)

• 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

• Progression Free Survival

  36 months

• Overall Survival

  36 months

Study Arms (1)

Cohort

FDG PET/CT assessed after 2 cycles of chemotherapy

Diagnostic Test: PET/CT

Interventions

PET/CT DIAGNOSTIC_TEST

FDG PET/CT assessed after 2 cycles of chemotherapy with PERCIST criteria

Cohort

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Assistance Publique - Hôpitaux de Paris: lead

Study Sites (1)

Hôpital Saint Louis

Paris, 75010, France

Location

MeSH Terms

Conditions

Colorectal Neoplasms

Interventions

Positron Emission Tomography Computed Tomography

Condition Hierarchy (Ancestors)

Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Rectal Diseases

Intervention Hierarchy (Ancestors)

Positron-Emission Tomography; Tomography, Emission-Computed; Image Interpretation, Computer-Assisted; Diagnostic Imaging; Diagnostic Techniques and Procedures; Diagnosis; Tomography, X-Ray Computed; Multimodal Imaging; Radiographic Image Enhancement; Image Enhancement; Photography; Radiography; Tomography, X-Ray; Radionuclide Imaging; Tomography; Diagnostic Techniques, Radioisotope

Study Officials

• Thomas Aparicio, MD

  Assistance Publique - Hôpitaux de Paris

  STUDY DIRECTOR

Central Study Contacts

Laetitia Vercellino, MD

CONTACT

+33142499411; laetitia.vercellino@aphp.fr

Lambert Jerome, MD

CONTACT

+33142494016; jerome.lambert@u-paris.fr

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 11, 2022
• First Posted: September 7, 2022
• Study Start: September 1, 2022
• Primary Completion: January 1, 2025
• Study Completion (Estimated): September 1, 2027
• Last Updated: September 7, 2022

Record last verified: 2022-08

Locations

FR (1)