Folfirinox: Patients meeting the criteria of post-operative adenocarcinoma of the ampulla of Vater will be enrolled, with adjuvant chemotherapy commencing within 8 weeks of recovery from surgery. Those undergoing palliative intent surgery or palliative chemotherapy are ineligible for the ADAPTA study.
The ADAPTA study's adjuvant chemotherapy involves 8-12 FOLFIRINOX cycles (Arm 2) repeated 2 weeks. Given patient outcomes, 8 cycles of FOLFIRINOX are deemed sufficient due to completion challenges in prior research. FOLFIRINOX regimen mirrors the modified version from the ACCORD/PRODIGE trial for metastatic pancreatic cancer. This trial adapts mFOLFIRINOX for standard practice.
Capox: or 8 CAPOX cycles (Arm 1) every 3 weeks.
Study summary
Ampullary adenocarcinoma (AAC) is a rare gastrointestinal cancer with varying survival rates, particularly the aggressive pancreatobiliary (PB) subtype. Adjuvant therapy benefits only PB and mixed subtype patients, while prospective studies are required for validation. A study proposes tailored adjuvant treatments (CAPOX for intestinal subtype, FOLFIRINOX for PB and mixed subtypes) based on histopathology to enhance survival, also exploring molecular sub-studies for deeper insights.
Eligibility
Sex
ALL
Min age
18 Years
Max age
100 Years
Healthy volunteers
Accepted
Inclusion Criteria:
* Adult patients with histologically or cytologically confirmed AAC with subtyping of pancreatobiliary/mixed subtype or intestinal subtype
* After curative resection for ampullary cancer without metastatic disease.
* WHO performance status 0 or 1
* Able and willing to receive adjuvant chemotherapy
* R0/ R1 resection
* Age ≥ 18 years
* Written informed consent
Exclusion Criteria:
* Prior radiotherapy, chemotherapy, or resection for AAC.
* Previous malignancy (excluding non-melanoma skin cancer), unless no evidence of disease and diagnosed more than 5 years before diagnosis of AAC.
* Pregnancy.
* R2 resection.
* Adjuvant chemotherapy started more than 12 weeks after surgery (aim to start within 8 weeks)
* Serious concomitant systemic disorders that would compromise the safety of the patient or his/her ability to complete the study, at the discretion of the investigator.
* Known hypersensitivity or contraindications against capecitabine, 5 FU, Irinotecan, or Oxaliplatin
* Inadequate organ functions, characterized by:
* Leucocytes (WBC) \< 3.0 X 109/l
* Neutrophils \< 1.500 (count per microliter of blood)
* Platelets \< 100 x 109 /l
* Hemoglobin \< 8 mmol/l
* Renal function: E-GFR \< 50 ml/min (serum creatinine \< 1.5 x UNL)
* cholestasis with elevated levels of bilirubin and/or alkaline phosphatase \> 3x UNL (can be improved by biliary drainage if necessary)
* elevated transaminases (ALAT/ASAT) ≥ 5 x UNL
* hypoalbuminemia \< 2.5 g/dl
* Inadequate coagulation status INR \> 2 or Quick \< 50%, aPTT \>50 sec in the absence of any drugs interfering with coagulation such as acenocoumarin, warfarin, phenprocoumon, NMH or UFH.
Primary outcome measure(s)
Disease-free survival (3y) — 3 years Disease-free survival (DFS) refers to the length of time after treatment for a disease in months, such as cancer, during which no signs or symptoms of the disease recur or progress. It is a crucial measure in assessing the effectiveness of a treatment regimen in preventing the return of the disease. In cancer contexts, DFS focuses on the period without disease recurrence or progression, highlighting the success of the treatment in controlling the illness.
Trial sites (1)
Facility
City
Region
Status
Fondazione Poliambulanza
Brescia
BS
Recruiting
More Fondazione Poliambulanza Istituto Ospedaliero trials in Italy
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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