NCT04894123

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

A Phase II Study Evaluating the Rate of Cardiovascular Events During Trifluridine/Tipiracil +/- Oxaliplatin Treatment in Colorectal/Oesogastric Adenocarcinoma Patients That Have Experienced a Past Episode of Thoracic Angina-related Pain Due to Chemotherapy Including 5-fluorouracil/Capecitabine

• Status: Terminated
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 1 (actual)
• Sponsor: GERCOR - Multidisciplinary Oncology Cooperative Group · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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 .

Detailed 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.

Conditions

• Colorectal Adenocarcinoma
• Oesogastric

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2022-02-07
• Primary completion: 2023-02-13
• Completion: 2023-02-13
• First posted: 2021-05-20
• Last updated: 2023-09-18

Locations

11 sites across 1 country: France