Locally Advanced or Metastatic Small Bowel AdenocarcinomaPhase 2FOLFORINOX SBANCT06278545
Trial Evaluating Modified FOLFIRINOX and Modified FOLFOX in the Treatment of Locally Advanced or Metastatic Small Bowel Adenocarcinoma
A Phase 2 study testing modified FOLFORINOX and Modified FOLFOX in people with Locally Advanced or Metastatic Small Bowel Adenocarcinoma, run by Centre Hospitalier Universitaire Dijon at 1 site in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Locally Advanced or Metastatic Small Bowel Adenocarcinoma
- What is being tested?
- modified FOLFORINOX and Modified FOLFOX
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 130 participants
- Where
- 1 siteFrance
- Study dates
- 16 Feb 2024to Feb 2029
- Phase
- Phase 2
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
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- 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.
Who cannot join
- 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
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- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
France1 site, 1 recruiting
- Recruiting
Chu Dijon Bourgogne
Dijon, 21000
Sylvain MANFREDI, +33 03 80 29 37 50, sylvain.manfredi@chu-dijon.fr
About this study
Official title: Randomized Phase II 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.
- Being tested
- modified FOLFORINOX, Modified FOLFOX
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
modified FOLFORINOXDrug
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 FOLFOXDrug
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
| Study group | Role | What they receive |
|---|---|---|
| Modified FOLFIRINOX regimen D1=D15 (1 course every 14 days) | Experimental | Not described Receives: Drug: modified FOLFORINOX |
| Modified FOLFOX regimen D1=D15 (1 course every 14 days) | Active comparator | Not described Receives: Drug: Modified FOLFOX |
What is being measured
The primary outcome is the main question the study is designed to answer.
Assess the percentage of patients alive without progression
Measured: At 8 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Feb 2024
- Study start16 Feb 2024
- Primary completionFeb 2027 (estimated)
- Study completionFeb 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Locally Advanced or Metastatic Small Bowel AdenocarcinomaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 130 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Universitaire Dijon
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06278545
- Sponsor's protocol ID
- MANFREDI PHRCK 2022
- Acronym
- FOLFORINOX SBA
- Status last verified
- Feb 2024
- First submitted
- 19 Feb 2024
- Last updated
- 26 Feb 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No