Actively Recruiting
Trial Evaluating Modified FOLFIRINOX and Modified FOLFOX in the Treatment of Locally Advanced or Metastatic Small Bowel Adenocarcinoma
Led by Centre Hospitalier Universitaire Dijon · Updated on 2024-02-26
130
Participants Needed
1
Research Sites
258 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Randomized, non-comparative, open-label, multi-centre Phase II study to evaluate modified FOLFIRINOX and modified FOLFOX in the locally advenced or metastatic small bowel adenocarcinoma. The primary objective is to assess the percentage of patients alive without prograssion at 8 months.
CONDITIONS
Official Title
Trial Evaluating Modified FOLFIRINOX and Modified FOLFOX in the Treatment of Locally Advanced or Metastatic Small Bowel Adenocarcinoma
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Histologically proven adenocarcinoma of the small intestine (duodenum, jejunum, ileum)
- Metastatic or locally advanced unresectable tumor with curative intent
- Patient who never received first-line chemotherapy
- Measurable lesion according to RECIST 1.1 criteria
- ECOG status �3 or less 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 informed consent note
- Women of childbearing age and men with partners of childbearing age must agree to use contraception during treatment and for at least 9 months after stopping treatment
You will not qualify if you...
- MSI/dMMR tumor
- Adenocarcinoma of the ampulla of Vater
- Neutrophils less than 1500/mm3 or platelets less than 100,000/mm3
- Hemoglobin less than 9 g/dL, total bilirubin more than 1.5 times normal, alkaline phosphatase more than 2.5 times normal (or more than 5 times normal if liver metastases), creatinine clearance under 40 ml/min
- Low potassium, magnesium, or calcium levels not corrected before enrollment
- 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 causing functional discomfort
- Active or severe uncontrolled infection or other conditions
- Treatment with cytochrome P450 inhibitors within 4 weeks before starting protocol treatment
- Current treatment with St John's Wort
- Treatment with brivudine within 4 weeks before starting protocol treatment
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Chu Dijon Bourgogne
Dijon, France, 21000
Actively Recruiting
Research Team
T
Thomas APARICIO
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here