Informations générales (source: ClinicalTrials.gov)
Randomized Phase II Trial Evaluating Modified FOLFIRINOX and Modified FOLFOX in the Treatment of Locally Advanced or Metastatic Small Bowel Adenocarcinoma
Interventional
Phase 2
Centre Hospitalier Universitaire Dijon (Voir sur ClinicalTrials)
février 2024
février 2029
12 septembre 2025
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.
Etablissements
| Les établissements d'Île-de-France ayant mis à jour leurs données Origine et niveau de fiabilité des données | |||||
|---|---|---|---|---|---|
| CLCC INSTITUT GUSTAVE ROUSSY | Michel DUCREUX | 20/04/2026 16:20:05 | Contacter | ||
| Les établissements sans correspondance certaine dans le répertoire FINESS dont les données sont issues de ClinicalTrials.gov Origine et niveau de fiabilité des données | |||||
| Chu Dijon Bourgogne - 21000 - Dijon - France | Sylvain MANFREDI | Contact (sur clinicalTrials) | |||
Critères
Tous
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.
- 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 < 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