Ampullary AdenocarcinomaPhase 3AMPIRINOXNCT06813976
PRODIGE 98 : Randomized, Multicenter Phase 3 Trial of Adjuvant Chemotherapy With Modified FOLFIRINOX Versus Capecitabine or Gemcitabine in Patients With Resected Ampullary Adenocarcinoma
A Phase 3 study testing mFOLFORINOX, Capecitabine or gemcitabine and Quality of life questionnaires: QLQ-C30 and PAN26 in people with Ampullary Adenocarcinoma, run by Centre Hospitalier Universitaire Dijon at 1 site in France.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Ampullary Adenocarcinoma
- What is being tested?
- mFOLFORINOX, Capecitabine or gemcitabine and Quality of life questionnaires: QLQ-C30 and PAN26
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 294 participants
- Where
- 1 siteFrance
- Study dates
- 2 Jul 2025to Jul 2033
- Phase
- Phase 3
- Are there results?
- Not yet: the study is under way
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 on surgical specimen
- Macroscopically complete surgical resection of an ampullary adenocarcinoma (R0 or R1)
- Adenocarcinoma removed within 12 weeks prior to enrollment
- Patients ≥ 18 years of age
- Patient without metastatic disease on CT scan < 4 weeks prior to inclusion
- WHO performance status 0 or 1 (WHO 0 if age >75)
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- Normal values of kalemia, magnesemia and calcemiaPatient able to understand and sign the information and informed consent note
- Women of childbearing age and men who are sexually active with women of childbearing age must agree to use highly effective contraception during the trial treatment at least until 6 months after the end of experimental treatment. Women of childbearing potential must use highly effective contraception at least 9 months after the end of treatment with oxaliplatin
- Patient affiliated to a social security scheme for France, or equivalents in European countries
- CA19.9 level < 180 U/L at inclusion (post-operative level)
Who cannot join
- Neoadjuvant systemic chemotherapy
- pT1N0M0 tumors
- Active infection by HBV, HCV or HIV
- Dihydropyrimidine dehydrogenase deficiency (uracilemia ≥ 16 ng/mL)
- Pre-existing peripheral neuropathy (grade ≥ 2)
- Unresolved or uncontrolled concomitant medical conditions
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- Neutrophils < 1500/mm3, platelets < 150 000/mm3, Haemoglobin < 9 g/dL
- Total bilirubin > 1.5x normal,
- Creatinine clearance < 50 ml/min according to MDRD
- AST or ALT > 2.5 x UNL, alkaline phosphatase > 2.5x normal at least 15 days after resection
- Patients with poor nutritional status represented by albuminemia < 30.0g/dl
- History of myocardial infarction within the last 6 months, severe coronary artery disease or severe heart failure
- Active and/or potentially severe infection
- Treatment with a strong cytochrome P450 inhibitor within 4 weeks prior to the administration of the protocol treatment (Treatment with Hypericum perforatum)
- Patient under treatment by brivudine, or treated by brivudine within 4 weeks prior to beginning of study treatment
- Concomitant use with St John's Wort
- QT/QTc interval longer than 450msec for men and longer than 470msec for women on the ECG
- Hypersensitivity to any of the study products or their excipients
- Administration of live vaccines within 28 days prior to randomization
- Other cancer treated within the last 5 years except adequately treated, in situ cervical carcinoma or basocellular/spinocellular carcinoma
- chronic bowel disease requiring specific treatment and/or intestinal obstruction
- Pregnant or breastfeeding woman
- Person under guardianship
- Inability to undergo the medical follow-up of the trial for geographical, social or psychological reasons
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, 0380293750, sylvain.manfredi@chu-dijon.fr
About this study
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.
Read more
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:
- Group A: mFOLFIRINOX: oxaliplatin, irinotecan, 5-fluorouracil, with folinic acid,
- group B: mono-chemotherapy with capecitabine or gemcitabine.
- Conditions
- Ampullary Adenocarcinoma
- Being tested
- mFOLFORINOX, Capecitabine or gemcitabine, Quality of life questionnaires: QLQ-C30 and PAN26, Biological assessment, Paraclinical examinations
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
mFOLFORINOXDrug
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
Capecitabine or gemcitabineDrug
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)
Quality of life questionnaires: QLQ-C30 and PAN26Other
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)
Biological assessmentBiological
Before each course of treatment and between courses of treatment if necessary
Paraclinical examinationsDiagnostic test
Every 3 months
| Study group | Role | What they receive |
|---|---|---|
| Experimental strategy | Experimental | Not described Receives: Drug: mFOLFORINOX; Other: Quality of life questionnaires: QLQ-C30 and PAN26; Biological: Biological assessment; Diagnostic Test: Paraclinical examinations |
| Standard treatments | Active comparator | Not described Receives: Drug: Capecitabine or gemcitabine; Other: Quality of life questionnaires: QLQ-C30 and PAN26; Biological: Biological assessment; Diagnostic Test: Paraclinical examinations |
What is being measured
The primary outcome is the main question the study is designed to answer.
Disease-free survival (DFS)
To compare DFS between the 2 arms of treatments in randomized patients
Measured: Assessed up to 36 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Feb 2025
- Study start2 Jul 2025
- Primary completionJul 2033 (estimated)
- Study completionJul 2033 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Ampullary AdenocarcinomaStudies of the same condition, open and under way.
- More trials run by Centre Hospitalier Universitaire DijonThe sponsor's other registered studies.
- 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 294 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
- NCT06813976
- Sponsor's protocol ID
- MANFREDI PHRCK 2023
- Acronym
- AMPIRINOX
- Status last verified
- Jul 2025
- First submitted
- 24 Dec 2024
- Last updated
- 11 Jul 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 41622055
Study at a glance
From the registry record, last updated by the sponsor on 11 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- PRODIGE 98 : Randomized, Multicenter Phase 3 Trial of Adjuvant Chemotherapy With Modified FOLFIRINOX Versus Capecitabine or Gemcitabine in Patients With Resected Ampullary Adenocarcinoma
- ClinicalTrials.gov ID
- NCT06813976
- Acronym / sponsor ID
- AMPIRINOX / MANFREDI PHRCK 2023
- Conditions
- Ampullary Adenocarcinoma
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 294 participants (estimated)
- Lead sponsor
- Centre Hospitalier Universitaire DijonUniversity, hospital or other
- Study start
- 2 Jul 2025 (actual)
- Primary completion
- Jul 2033 (estimated)
- Study completion
- Jul 2033 (estimated)
- First posted
- 7 Feb 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- Group A: mFOLFIRINOX: oxaliplatin, irinotecan, 5-fluorouracil, with folinic acid,
- group B: mono-chemotherapy with capecitabine or gemcitabine.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Experimental strategy | Experimental | Drug: mFOLFORINOX, Other: Quality of life questionnaires: QLQ-C30 and PAN26, Biological: Biological assessment, Diagnostic Test: Paraclinical examinations |
| Standard treatments | Active comparator | Drug: Capecitabine or gemcitabine, Other: Quality of life questionnaires: QLQ-C30 and PAN26, Biological: Biological assessment, Diagnostic Test: Paraclinical examinations |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Histologically proven adenocarcinoma on surgical specimen
- Macroscopically complete surgical resection of an ampullary adenocarcinoma (R0 or R1)
- Adenocarcinoma removed within 12 weeks prior to enrollment
- Patients ≥ 18 years of age
- Patient without metastatic disease on CT scan < 4 weeks prior to inclusion
Key exclusion criteria (24 listed)
- Neoadjuvant systemic chemotherapy
- pT1N0M0 tumors
- Active infection by HBV, HCV or HIV
- Dihydropyrimidine dehydrogenase deficiency (uracilemia ≥ 16 ng/mL)
- Pre-existing peripheral neuropathy (grade ≥ 2)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| mFOLFORINOXmFOLFIRINOX 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 | Drug | Experimental strategy |
| Capecitabine or gemcitabineinvestigator'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) | Drug | Standard treatments |
| Quality of life questionnaires: QLQ-C30 and PAN26Before 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) | Other | Experimental strategy, Standard treatments |
| Biological assessmentBefore each course of treatment and between courses of treatment if necessary | Biological | Experimental strategy, Standard treatments |
| Paraclinical examinationsEvery 3 months | Diagnostic test | Experimental strategy, Standard treatments |
Primary outcome
Disease-free survival (DFS)
Time frame: Assessed up to 36 months
To compare DFS between the 2 arms of treatments in randomized patients
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Jul 2025.
- Derived from this study: PubMed 41622055Roth 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing mFOLFORINOX, Capecitabine or gemcitabine and Quality of life questionnaires: QLQ-C30 and PAN26 in people with Ampullary Adenocarcinoma, run by Centre Hospitalier Universitaire Dijon at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 24 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 11 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Gaël ROTH (04 76 76 51 68, groth@chu-grenoble.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Disease-free survival (DFS) (time frame: Assessed up to 36 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06813976, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Jul 2025.