Evaluating chemotherapy regimens for advanced small bowel cancer
Randomized Phase II Trial Evaluating Modified FOLFIRINOX and Modified FOLFOX in the Treatment of Locally Advanced or Metastatic Small Bowel Adenocarcinoma
This study is testing two different chemotherapy treatments to see if they can help people with advanced small bowel cancer live longer without their disease getting worse.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Enrollment | 130 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Centre Hospitalier Universitaire Dijon Academic / other |
| Drugs / interventions | chemotherapy |
| Locations | 1 site (Dijon) |
| Trial ID | NCT06278545 on ClinicalTrials.gov |
What this trial studies
This Phase II clinical trial is a randomized, non-comparative, open-label study designed to evaluate the effectiveness of modified FOLFIRINOX and modified FOLFOX chemotherapy regimens in patients with locally advanced or metastatic small bowel adenocarcinoma. The primary objective is to determine the percentage of patients who remain alive without disease progression at 8 months. Participants must have histologically confirmed adenocarcinoma and meet specific eligibility criteria regarding their health status and prior treatments.
Who should consider this trial
Good fit: Ideal candidates include adults over 18 with unresectable metastatic or locally advanced small bowel adenocarcinoma who have not received prior chemotherapy.
Not a fit: Patients with MSI/dMMR tumors or those with adenocarcinoma of the ampulla of Vater may not benefit from this study.
Why it matters
Potential benefit: If successful, this trial could provide a new effective treatment option for patients with advanced small bowel adenocarcinoma.
How similar studies have performed: While this approach is being evaluated in this specific context, similar chemotherapy regimens have shown promise in treating other types of cancers, suggesting potential for success.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Dijon
- Chu Dijon Bourgogne — Dijon, France (Recruiting)
Study contacts
- Study coordinator: Thomas APARICIO
- Email: Thomas.aparicio@aphp.fr
- Phone: +33 01 42 49 95 97
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.