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Not yet recruiting NCT05531045

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

— Observational Metastatic Colorectal Cancer

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: PET/CT.
Who it may be relevant to
Registry conditions: Metastatic Colorectal Cancer. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
France
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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Official title

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

Overview

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).

Interventions

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

Primary outcome measures

  • early metabolic response assessed by PERCIST criteria [Time frame: 4 months]
Secondary outcome measures (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 [Time frame: at the end of first line chemotherapy, an average of 12 months]
  • Best morphological response during the course of first line chemotherapy [Time frame: 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 [Time frame: Month 2]
  • Progression Free Survival [Time frame: 36 months]
  • Overall Survival [Time frame: 36 months]
  • ΔSUVmax (EORTC criteria) between Pre-therapeutic and 2 cycles PET assessment [Time frame: 2 months]
  • ΔSULpeak (PERCIST criteria) between Pre-therapeutic and 2 cycles PET assessment [Time frame: 2 months]
  • ΔMTV between Pre-therapeutic and 2 cycles PET assessment [Time frame: 2 months]
  • ΔTLG between Pre-therapeutic and 2 cycles PET assessment [Time frame: 2 months]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model
Cohort

Study locations

France · 1 center
  • Hôpital Saint Louis — Paris

Identifiers

NCT: NCT05531045 · APHP180576

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗