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Trial Title:
Trial Evaluating Modified FOLFIRINOX and Modified FOLFOX in the Treatment of Locally Advanced or Metastatic Small Bowel Adenocarcinoma
NCT ID:
NCT06278545
Condition:
Locally Advanced or Metastatic Small Bowel Adenocarcinoma
Conditions: Official terms:
Adenocarcinoma
Study type:
Interventional
Study phase:
Phase 2
Overall status:
Recruiting
Study design:
Allocation:
Randomized
Intervention model:
Parallel Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Drug
Intervention name:
modified FOLFORINOX
Description:
One treatment every 14 days :
- Irinotecan 180mg/m² as a 2-hour IV infusion
- Oxaliplatin 85 mg/m² as a 2-hour IV infusion
- Folinic acid 400 mg/m² as 2-hour IV infusion, in Y with oxaliplatin
- 5-FU 2400 mg/m² as a continuous IV infusion over 46 hours
Arm group label:
Modified FOLFIRINOX regimen D1=D15 (1 course every 14 days)
Intervention type:
Drug
Intervention name:
Modified FOLFOX
Description:
One treatment every 14 days:
- Oxaliplatin 85 mg/m by IV infusion over 2 hours
- Folinic acid: 400 mg/m² or 200 mg/m² if laevorotatory form by IV infusion over 2
hours, in Y with oxaliplatin
- 5FU bolus: 400 mg/m² per 10-minute IV infusion
- 5 FU continuous 2400 mg/m² by IV infusion over 46 hours
Arm group label:
Modified FOLFOX regimen D1=D15 (1 course every 14 days)
Summary:
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.
Criteria for eligibility:
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
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
Chu Dijon Bourgogne
Address:
City:
Dijon
Zip:
21000
Country:
France
Status:
Recruiting
Contact:
Last name:
Sylvain MANFREDI
Phone:
+33 03 80 29 37 50
Email:
sylvain.manfredi@chu-dijon.fr
Start date:
February 16, 2024
Completion date:
February 2029
Lead sponsor:
Agency:
Centre Hospitalier Universitaire Dijon
Agency class:
Other
Source:
Centre Hospitalier Universitaire Dijon
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06278545
