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New treatment option for Locally Advanced or Metastatic Small Bowel Adenocarcinoma
Official title Trial Evaluating Modified FOLFIRINOX and Modified FOLFOX in the Treatment of Locally Advanced or Metastatic Small Bowel Adenocarcinoma
ClinicalTrials.gov ID: NCT06278545
What this study is testing
What is modified FOLFORINOX?
modified FOLFORINOX is an investigational medicine, given as an infusion into a vein, being studied as a potential treatment for locally advanced or metastatic small bowel adenocarcinoma.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 2: a mid-size study of how well it works
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
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
You likely can't join if
- MSI/dMMR tumor
- Adenocarcinoma of the ampulla of Vater
- Neutrophils \< 1500/mm3, platelets \< 100 000/mm3
- Hemoglobin \ 1.5x normal, alkaline phosphatase \> 2.5x normal (or \>5x normal if liver metastases), creatinine clearance \> or = 40 ml/min. according...
- Hypokalaemia, hypomagnesaemia and hypocalcaemia below normal, and for calcaemia, it must be corrected before enrolment.
- Adjuvant chemotherapy completed less than 6 months ago
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
- 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.
- MSI/dMMR tumor
- Adenocarcinoma of the ampulla of Vater
- Neutrophils \< 1500/mm3, platelets \< 100 000/mm3
- Hemoglobin \ 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
The study team makes the final eligibility decision.
Where it's taking place
- Dijon, France
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, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Dijon, France. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.