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

NCT04894123 · Status: TERMINATED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 1

Last updated 2023-09-18

No results posted yet for this study

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 .

Conditions

  • Colorectal Adenocarcinoma
  • Oesogastric

Interventions

DRUG

Trifluridine/Tipiracil

Trifluridine/tipiracil : 35 mg/m² orally twice a day from day 1 to day 5 every 14 days. If oxaliplatin is stopped or it is not indicated, trifluridine/tipiracil in monotherapy 35 mg/m² orally twice a day between days 1-5 and days 8-12; repeated every 28 days.

DRUG

Oxaliplatin

Oxaliplatin : 85 mg/m² intravenous at day 1 every 14 days.

Sponsors & Collaborators

  • Servier

    collaborator INDUSTRY

  • GERCOR - Multidisciplinary Oncology Cooperative Group

    lead OTHER

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-02-07
Primary Completion
2023-02-13
Completion
2023-02-13

Countries

  • France

Study Locations

More Related Trials

Entities

Drugs
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04894123 on ClinicalTrials.gov