Cardiovascular Events From Trifluridine/Tipiracil +/- Oxaliplatin in Colorectal/Oesogastric Adenocarcinoma Patients

  • STATUS
    Recruiting
  • End date
    Jan 21, 2025
  • participants needed
    49
  • sponsor
    GERCOR - Multidisciplinary Oncology Cooperative Group
Updated on 21 March 2022

Summary

The purpose of this study is to assess the incidence of cardiovascular events in patients with esophageal/stomach or colorectal cancer treated by trifluridine/tipiracil +/- oxaliplatin after an episode of cardiac angina-related thoracic pain due to fluoropyrimidines in the adjuvant or metastatic setting .

Description

After being informed about the study and potential risks, all patients giving written informed consent will undergo a 14-day screening period to determine eligibility for study entry. Patient who meet the eligibility requirement will be included in the study and will be treated by trifluridine/tipiracil +/- oxaliplatin.

Details
Condition Colorectal Adenocarcinoma, Oesogastric
Treatment Oxaliplatin, Trifluridine/Tipiracil
Clinical Study IdentifierNCT04894123
SponsorGERCOR - Multidisciplinary Oncology Cooperative Group
Last Modified on21 March 2022

Eligibility

Yes No Not Sure

Inclusion Criteria

Signed and dated informed consent and willingness to comply with all study procedures and availability for the study duration
Instable angina
Histologically confirmed oesogastric, gastric, colon and/or rectum adenocarcinoma
Patients with metastatic non-resectable (oesogastric or colorectal) or adjuvant (colorectal stage III) adenocarcinoma previously treated by fluoropyrimidines (5-FU or capecitabine)
Age ≥18 years
Eastern Cooperative Oncology Group performance status (ECOG PS) of 0-2
Patients who presented an episode of cardiac angina-related thoracic pain due to 5- FU or capecitabine (minimum 21 days [3 weeks] between event and inclusion) at least one of the following events
Acute coronary syndrome (ACS) without ST-segment elevation nor troponin rise
Contraindication to continue treatment with 5FU or capecitabine confirmed and
documented by a cardiologist,CONFIDENTIAL Protocol ACOTAS version 1.5
06/2021 Page 32 of 93
Indication to receive trifluridine/tipiracil ± oxaliplatin considered better than absence of therapy (colo-rectal stage III) or the best alternative therapy (metastatic colo-rectal and oeso-gastric or gastric) confirmed by a Multidisciplinary Consultation Meeting
No contraindication to receive trifluridine/tipiracil (related toxicity)
No prior treatment with trifluridine/tipiracil
Following laboratory values obtained within 14 days (2 weeks) prior to start of study
Registration in a national health care system (PUMa - Protection Universelle Maladie included)
treatment
Hematological status: absolute neutrophil count (ANC) ≥ 1.5 x 109/L; platelets ≥ 100 x 109/L; hemoglobin ≥ 9 g/dL
Adequate renal function: serum creatinine level < 150 µM and creatinine clearance ≥ 50 ml/min using the Cockroft-Gault formula
Adequate liver function: serum total bilirubin ≤ 1.5 x upper limit of normal (ULN), alkaline phosphatase (ALP) < 5 x ULN, aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤ 2.5 x ULN
For female patients of childbearing potential, negative serum pregnancy test within 7
days (1 week) prior starting the study treatment
Female patients of childbearing potential must commit to using reliable and effective methods of contraception during the trial and until at least 12 months after the end of study treatment. Male patients with a partner of childbearing potential must agree to use effective contraception in addition to the contraceptive method used by their partner during the trial and until at least 9 months after the end of study treatment

Exclusion Criteria

For metastatic colo-rectal-cancer, MSI and/or dMMR tumor
For metastatic oeso-gastric and gastric adenocarcinoma, HER+++ or HER++ FISH positive tumor
Left ventricular dysfunction with a left ventricular ejection fraction (LVEF) < 35% with or without an automatic implantable defibrillator
Non-revascularized multivessel coronary artery disease
ACS with ST elevation, and/ or troponin rise
QT/QTc interval > 470 ms (for women) and > 450 ms (for men) NB: Caution is required when using medicinal products with human thymidine kinase substrates, e.g. zidovudine and other drugs known to prolong the QTc interval (exhaustive list on https: //[www.crediblemeds.org](http://www.crediblemeds.org/).")
Documented coronary vasospasm during 5-FU treatment leading to myocardial infarction
Pregnancy and breastfeeding
Treatment with any other investigational medicinal product within 28 days (4 weeks) before start of the study treatment
Rare hereditary problems of galactose intolerance, the Lapp lactose deficiency, or glucose-galactose malabsorption
Any other serious and uncontrolled non-malignant disease
Major surgery or traumatic injury within 28 days (4 weeks) before the start of study treatment
Patients with known allergy to any excipient to study drugs
Bowel obstruction or inability to swallow tablets
Peripheral neuropathy Grade > 1 for the oxaliplatin schedule
Non resolved non-hematological toxicities from prior therapies (grade >2)
Abnormal values at inclusion for
kalemia
Magnesemia
Calcemia and corrected calcium level
Impossibility of submitting to the medical follow-up of the study for geographical, social reasons or psychiatric illness
Patients admitted to a health or social establishment for purposes other than that of the study
Patient under a legal protection regime (guardianship, curatorship, judicial
safeguard), or administrative decision, or incapable of giving his/her consent
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Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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