Trial Evaluating Modified FOLFIRINOX and Modified FOLFOX in the Treatment of Locally Advanced or Metastatic Small Bowel Adenocarcinoma

NCT ID: NCT06278545

Last Updated: 2024-02-26

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: PHASE2
• Total Enrollment: 130 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-02-16
• Study Completion Date: 2029-02-28

Brief 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.

Conditions

Locally Advanced or Metastatic Small Bowel Adenocarcinoma

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Modified FOLFIRINOX regimen D1=D15 (1 course every 14 days)

Group Type: EXPERIMENTAL

modified FOLFORINOX

Intervention Type: DRUG

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

Modified FOLFOX regimen D1=D15 (1 course every 14 days)

Group Type: ACTIVE_COMPARATOR

Modified FOLFOX

Intervention Type: DRUG

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

Interventions

modified FOLFORINOX

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

Intervention Type: DRUG

Modified FOLFOX

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

Intervention Type: DRUG

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Centre Hospitalier Universitaire Dijon

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Chu Dijon Bourgogne

Dijon, , France

Site Status: RECRUITING

Countries

France

Central Contacts

Thomas APARICIO

Role: CONTACT

Thomas.aparicio@aphp.fr

+33 01 42 49 95 97

Facility Contacts

Sylvain MANFREDI

Role: primary

sylvain.manfredi@chu-dijon.fr

+33 03 80 29 37 50

Other Identifiers

MANFREDI PHRCK 2022

Identifier Type: -

Identifier Source: org_study_id