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

Recruiting Phase 2 Interventional Study
Locally Advanced or Metastatic Small Bowel Adenocarcinoma
No Placebo Group Every participant receives an active treatment — no one gets a placebo. Prior Safety Data This treatment has already been tested in at least one earlier human trial.
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At a Glance
Age
18 and older
Sex
Any
Trial phase
Phase 2
Study type
Interventional
Purpose
Treatment
Participants needed
130 (estimated)
Sponsor
Centre Hospitalier Universitaire Dijon · Other
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About This Trial

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.

Trial Locations
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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 sta…
Contacts

Thomas APARICIO

+33 01 42 49 95 97

Thomas.aparicio@aphp.fr

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