Trial Evaluating Modified FOLFIRINOX and Modified FOLFOX in the Treatment of Locally Advanced or Metastatic Small Bowel Adenocarcinoma

Launched by CENTRE HOSPITALIER UNIVERSITAIRE DIJON · Feb 19, 2024

Keywords

ClinConnect Summary

This clinical trial is designed to study two different chemotherapy treatments, modified FOLFIRINOX and modified FOLFOX, for patients with locally advanced or metastatic small bowel adenocarcinoma, which is a type of cancer that starts in the small intestine. The main goal of the trial is to see how many patients are alive without their cancer getting worse after 8 months of treatment. The trial is currently recruiting participants who are between 18 and 74 years old and have not received any chemotherapy before for their condition.

To qualify for the trial, patients must have a confirmed diagnosis of small bowel adenocarcinoma that cannot be surgically removed and should have measurable cancer. They also need to be in relatively good health, with a life expectancy of at least three months. Participants who join the study will receive one of the two treatments and will be closely monitored for their health and response to the therapy. It's important for potential participants to understand that there are specific health criteria that must be met to ensure their safety during the trial.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • Histologically proven adenocarcinoma of the small intestine (duodenum, jejunum, ileum)
• • Metastatic or locally advanced unresectable tumour with curative intent
• • Patient who never received first-line chemotherapy
• • Measurable lesion according to RECIST 1.1 criteria
• • ECOG status \< or = 2 for patients under 70 years, or 0 or 1 for patients over 70 years
• • Life expectancy estimated at over 3 months
• • Patient over 18 years of age
• • Patient able to understand and sign the information and informed consent note
• • Women of childbearing age and men who have sex with women of childbearing age must agree to use contraception during the trial treatment and for at least 9 months after stopping the experimental treatments.
• Exclusion Criteria:
• • MSI/dMMR tumor
• • Adenocarcinoma of the ampulla of Vater
• • Neutrophils \< 1500/mm3, platelets \< 100 000/mm3
• • Hemoglobin \< 9 g/dL, total bilirubin \> 1.5x normal, alkaline phosphatase \> 2.5x normal (or \>5x normal if liver metastases), creatinine clearance \> or = 40 ml/min. according to MDRD
• • Hypokalaemia, hypomagnesaemia and hypocalcaemia below normal, and for calcaemia, it must be corrected before enrolment.
• • Adjuvant chemotherapy completed less than 6 months ago
• • History of myocardial infarction within the last 6 months, severe coronary artery disease or severe heart failure
• • Severe renal failure
• • Peripheral sensory neuropathy with functional discomfort
• • Active and/or potentially severe infection or other uncontrolled conditions
• • Treatment with a cytochrome P450 inhibitor within 4 weeks prior to the administration of the protocol treatment (refer to paragraph 8.3 "Contraindicated treatments" of the protocol)
• • Patients currently undergoing treatment using St John's Wort
• • Treatment with brivudine within 4 weeks prior to the administration of protocol