Recruiting

NCT Number: NCT06278545

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

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.

Recruiting

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Key information

Conditions

Locally Advanced or Metastatic Small Bowel Adenocarcinoma

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Chu Dijon Bourgogne

Dijon, 21000, France

Location status: Recruiting

Location contact

Sylvain MANFREDI

CONTACT

[email protected]

+33 03 80 29 37 50

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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 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

Primary outcomes

Assess the percentage of patients alive without progression

Time frame: At 8 months

Study contacts

Contact information is provided by the study sponsor or research team.

Thomas APARICIO

CONTACT

[email protected]

+33 01 42 49 95 97

Sponsors and collaborators

Lead sponsor

Centre Hospitalier Universitaire Dijon

Other

Registry information

Official study title

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

Acronym: FOLFORINOX SBA

Important dates

Study start: 2024
Primary completion: 2027
Study completion: 2029
First posted: Feb 26, 2024
Registry last updated: Feb 26, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.