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ENGIC 02 - PRODIGE 86-FOLFIRINOX SBA- Phase II randomized trial evaluating modified FOLFIRINOX and FOLFOX in the treatment of locally advanced or metastatic small bowel adenocarcinoma
EU CTIS ID: 2023-505486-92-00
What this study is testing
Assessment of the percentage of patients alive without progression at 8 months
- Therapeutic exploratory (Phase II)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- 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
You likely can't join if
- MSI/dMMR tumor
- Treatment with a cytochrome P450 inhibitor within 4 weeks prior to the administration of the protocol treatment
- Uncontrolled inflammatory bowel disease and/or unresolved bowel obstruction
- Administration of live vaccines within 28 days prior to randomization
- Adenocarcinoma of the ampulla of Vater
- Neutrophils < 1500/mm3, platelets < 100 000/mm3
See the full eligibility 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
- MSI/dMMR tumor
- Treatment with a cytochrome P450 inhibitor within 4 weeks prior to the administration of the protocol treatment
- Uncontrolled inflammatory bowel disease and/or unresolved bowel obstruction
- Administration of live vaccines within 28 days prior to randomization
- 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
- 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
The study team makes the final eligibility decision.
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 65+ years, 18-64 years. The study team makes the final eligibility decision.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.