NCT06813976|RecruitingPhase 3
PRODIGE 98 : Randomized, Multicenter Phase 3 Trial of Adjuvant Chemotherapy With Modified FOLFIRINOX Versus Capecitabine or Gemcitabine in Patients With Resected Ampullary Adenocarcinoma
AMPIRINOX
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Sponsor study identifier
interventional
294
1 country
1
Study Start
July 2, 2025
Actual (reported)Primary Completion
July 2033
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Study Completion
July 2033
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Ampullary adenocarcinoma (AMPAC) is a rare cancer (0.2% of digestive cancers) affecting the ampulla of Vater. The only curative treatment is surgery, but around 4% of patients recur within 2 years of surgical resection. The aim of adjuvant chemotherapy is to reduce the risk of disease recurrence, and the only chemotherapies that can be considered standard to date are capecitabine and gemcitabine. In this trial, an alternative experimental treatment strategy using modified FOLFORINOX (mFOLFORINOX) is proposed. It consists of 3 chemotherapies with complementary actions: 5-fluorouracil, irinotecan and oxaliplatin, combined with folic acid a vitamin that enhances the efficacy of 5-fluorouracil. This study proposes 2 treatment schemes:
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
July 2033
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
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Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
December 24, 2024
Actual (reported)February 7, 2025
Actual (reported)July 2, 2025
Actual (reported)July 2033
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
July 2033
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Disease-free survival (DFS)
To compare DFS between the 2 arms of treatments in randomized patients
Assessed up to 36 months
mFOLFIRINOX every 2 weeks during 12 cycles (24 weeks): * Oxaliplatin 85 mg/m² * Irinotecan 150 mg/m² * Leucovorin 400 mg/m² * Fluorouracil 2400 mg/m² during 46 hours
investigator's choice: * Capecitabine 1250 mg/m² BID, 2 weeks on, 1 week off during 8 cycles (24 weeks) OR * Gemcitabine 1000 mg/m² in 30 min; 3 weeks on, 1 week of, during 6 cycles ((24 weeks)
These entries preserve how the registry describes the intervention. Their treatment roles are shown separately from molecular identities.
Formulated product
OXALIPLATIN
The registry describes a specific formulation. Its exact chemical ingredients and approval status require separate evidence.
SOLUTION FOR INFUSION
View registry recordFormulated product
IRINOTECAN
The registry describes a specific formulation. Its exact chemical ingredients and approval status require separate evidence.
SOLUTION FOR INFUSION
View registry recordFormulated product
Capecitabine Accord 150 mg film-coated tablets
The registry describes a specific formulation. Its exact chemical ingredients and approval status require separate evidence.
FILM-COATED TABLET
View registry recordFormulated product
GEMCITABINE HYDROCHLORIDE
The registry describes a specific formulation. Its exact chemical ingredients and approval status require separate evidence.
SOLUTION FOR INFUSION
View registry recordFormulated product
Capecitabine Accord 500 mg film-coated tablets
The registry names these ingredients. The formulation’s exact chemical form has not been confirmed.
OXALIPLATIN
Named ingredient: Oxaliplatin
View registry recordIRINOTECAN
Named ingredient: Irinotecan
View registry recordCapecitabine Accord 150 mg film-coated tablets
Named ingredient: Capecitabine
View registry recordGEMCITABINE HYDROCHLORIDE
Named ingredient: Gemcitabine hydrochloride
View registry recordCapecitabine Accord 500 mg film-coated tablets
Named ingredient: Capecitabine
View registry recordCapecitabine Accord 300 mg film-coated tablets
Named ingredient: Capecitabine
View registry recordFLUOROURACIL
Named ingredient: Fluorouracil
CHU Dijon Bourgogne
Dijon, 21000, France
Roth GS, Cros J, Neuzillet C, Barbier E, Guarssifi M, Bennacer A, Ducreux M, Muller M, Edeline J, Manfredi S, Williet N, Dusetti N, Laurent-Puig P, Ruffino V, Chanez B, Nicolle R, Taieb J, Malka D. Randomized, multicenter Phase III trial of adjuvant chemotherapy with modified FOLFIRINOX versus capecitabine or gemcitabine in patients with resected ampullary adenocarcinoma. Dig Liver Dis. 2026 Mar;58(3):308-314. doi: 10.1016/j.dld.2026.01.211. Epub 2026 Jan 31.
First Submitted
December 24, 2024
First Posted
February 7, 2025
Study Start
July 2, 2025
Actual (reported)Primary Completion
July 2033
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Eating Disturbances in Patients With Type 1 Diabetes Initiating Insulin Therapy
Before treatment, during treatment (every 12 weeks in any treatment arm Until disease progression or end of follow-up) and after treatment discontinuation (30 days after the end of treatment)
Before each course of treatment and between courses of treatment if necessary
Every 3 months
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
The registry describes a specific formulation. Its exact chemical ingredients and approval status require separate evidence.
FILM-COATED TABLET
Formulated product
Capecitabine Accord 300 mg film-coated tablets
The registry describes a specific formulation. Its exact chemical ingredients and approval status require separate evidence.
FILM-COATED TABLET
View registry recordFormulated product
FLUOROURACIL
The registry describes a specific formulation. Its exact chemical ingredients and approval status require separate evidence.
SOLUTION FOR INFUSION
View registry recordGrouped treatment entry
Capecitabine or gemcitabine
The registry names several treatments. This does not confirm that participants received them together or that they form a single product.
View registry recordContact the study team to confirm eligibility.
Study Completion
July 2033
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Last Updated
July 11, 2025
Record last verified: 2025-07
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Source: ClinicalTrials.gov.
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