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NCT Number: NCT05531045

18FFDG PET/CT 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).

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Hôpital Saint Louis

Paris, 75010, France

Location contact

Thomas Aparico, MD

CONTACT

[email protected]

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

PET/CT

Diagnostic Test

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

Primary outcomes

  1. early metabolic response assessed by PERCIST criteria

    Time frame: 4 months

Secondary outcomes

  1. 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

  2. Best morphological response during the course of first line chemotherapy

    Time frame: at the end of first line chemotherapy, an average of 12 months

  3. percentage of cases where early metabolic response evaluation would have led to a modification of the therapeutic strategy/management

    Time frame: Month 2

  4. Progression Free Survival

    Time frame: 36 months

  5. Overall Survival

    Time frame: 36 months

  6. ΔSUVmax (EORTC criteria) between Pre-therapeutic and 2 cycles PET assessment

    Time frame: 2 months

  7. ΔSULpeak (PERCIST criteria) between Pre-therapeutic and 2 cycles PET assessment

    Time frame: 2 months

  8. ΔMTV between Pre-therapeutic and 2 cycles PET assessment

    Time frame: 2 months

  9. ΔTLG between Pre-therapeutic and 2 cycles PET assessment

    Time frame: 2 months

Study contacts

Contact information is provided by the study sponsor or research team.

Laetitia Vercellino, MD

CONTACT

[email protected]

+33142499411

Lambert Jerome, MD

CONTACT

[email protected]

+33142494016

Sponsors and collaborators

Lead sponsor

Assistance Publique - Hôpitaux de Paris

Other

Registry information

Official study title

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

Acronym: TEP-PREDICT

Important dates

Study start
2022
Primary completion
2025
Study completion
2027
First posted
Sep 7, 2022
Registry last updated
Sep 7, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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