colorectal or oesogastric adenocarcinoma MedDRA version: 21.0 Level: PT Classification code 10052360 Term: Colorectal adenocarcinoma System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA version: 21.1 Level: PT Classification code 10017758 Term: Gastric cancer System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Conditions
Interventions
Trade Name: Lonsurf
Product Name: Lonsurf
Pharmaceutical Form: Tablet
Trade Name: oxaliplatin
Product Name: oxaliplatin
Pharmaceutical Form: Solution for infusion
INN or Proposed INN: OXALIPLATIN
CAS
Sponsors
GERCOR
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Signed and dated informed consent and willingness to comply with all study procedures and availability for the study duration, 2. Histologically confirmed oesogastric, gastric, colon and/or rectum adenocarcinoma, 3. Patients with metastatic non-resectable (oesogastric or colorectal) or adjuvant (colorectal stage III) adenocarcinoma previously treated by fluoropyrimidines (5-FU or capecitabine), 4. Age =18 years, 5. Eastern Cooperative Oncology Group performance status (ECOG PS) of 0-2, 6. 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: - Instable angina , - Acute coronary syndrome (ACS) without ST-segment elevation nor troponin rise. 7. Contraindication to continue treatment with 5FU or capecitabine confirmed and documented by a cardiologist, 8. 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, 9. No contraindication to receive trifluridine/tipiracil (related toxicity), 10. No prior treatment with trifluridine/tipiracil, 11. Following laboratory values obtained within 14 days (2 weeks) prior to start of study 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 =65 years) yes F.1.3.1 Number of subjects for this age range 9
Exclusion criteria
Exclusion criteria: 1. For metastatic colo-rectal-cancer, MSI and/or dMMR tumor 2. For metastatic oeso-gastric and gastric adenocarcinoma, HER+++ or HER++ FISH positive tumor 3. Left ventricular dysfunction with a left ventricular ejection fraction (LVEF) 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.” 7. Documented coronary vasospasm during 5-FU treatment leading to myocardial infarction, 8. Pregnancy and breastfeeding, 9. Treatment with any other investigational medicinal product within 28 days (4 weeks) before start of the study treatment, 10. Rare hereditary problems of galactose intolerance, the Lapp lactose deficiency, or glucose-galactose malabsorption, 11. Any other serious and uncontrolled non-malignant disease, 12. Major surgery or traumatic injury within 28 days (4 weeks) before the start of study treatment, 13. Patients with known allergy to any excipient to study drugs, 14. Bowel obstruction or inability to swallow tablets, 15. Peripheral neuropathy Grade > 1 for the oxaliplatin schedule, 16.Non resolved non-hematological toxicities from prior therapies (grade >2) 17. Abnormal values at inclusion for : - kalemia ; - Magnesemia; - Calcemia and corrected calcium level 18. Patient under a legal protection regime (guardianship, curatorship or judicial safeguard, or administrative decision or incapable of giving his/her consent 19. Impossibility of submitting to the medical follow-up of the study for geographical, social reasons or psychiatric illness 20. Patients admitted to a health or social establishment for purposes other than that of the study
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To assess the rate of cardiovascular events in patients treated with trifluridine/tipiracil +/- oxaliplatin over a 3-month period. Cardiovascular events are defined as follows: - Acute coronary syndrome without ST segment elevation, - Acute coronary syndrome with ST segment elevation, - Acute myocardial infarction, - Heart failure, - Arrhythmia (atrial fibrillation, flutter, junctional tachycardia, ventricular tachycardia), - Cardiovascular death, - Sudden death of any cause. ;Secondary Objective: - To evaluate the safety profile of the trifluridine/tipiracil and oxaliplatin combination (National Cancer Institute Common Terminology Criteria for Adverse Events [NCI-CTCAE] v 5.0), - To evaluate disease control rate (DCR; the proportion of patients who experience a partial response, complete response (CR), or have stable disease as their best response), - To evaluate the 3-month drop-out rate for limiting toxicity.;Primary end point(s): The rate of cardiovascular events at 3 months;Timepoint(s) of evaluation of this end point: 3 months | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): - The incidence of AEs (NCI-CTCAE v5.0) - Disease control rate (DCR) - The 3-month drop-out rate for limiting toxicity ;Timepoint(s) of evaluation of this end point: - AEs : every visit during treatment and until 28 days after the last dose (NCI-CTCAE version 5.0) - until 3 months of the last visit of the last patient - 3 months | — |
Countries
France
Contacts
Public ContactRegulatory Affairs
GERCOR
Outcome results
None listed