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

NCT06278545 | Recruiting Phase 2

• 1 other identifier: MANFREDI PHRCK 2022
• Study Type: interventional
• Target: 130
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (1)

• Assess the percentage of patients alive without progression

  At 8 months

Study Arms (2)

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

EXPERIMENTAL

Drug: modified FOLFORINOX

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

ACTIVE COMPARATOR

Drug: Modified FOLFOX

Interventions

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

Modified FOLFOX 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

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

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify 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
• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Centre Hospitalier Universitaire Dijon: lead

Study Sites (1)

Chu Dijon Bourgogne

Dijon, 21000, France

RECRUITING

Central Study Contacts

Thomas APARICIO

CONTACT

+33 01 42 49 95 97; Thomas.aparicio@aphp.fr

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 19, 2024
• First Posted: February 26, 2024
• Study Start: February 16, 2024
• Primary Completion (Estimated): February 1, 2027
• Study Completion (Estimated): February 1, 2029
• Last Updated: February 26, 2024

Record last verified: 2024-02

Locations

FR (1)