The ADAPTA Study: ADjuvant chemotherAPy After Curative Intent resecTion of Ampullary Cancer.
The ADAPTA Study: ADjuvant chemotherAPy After Curative Intent resecTion of Ampullary Cancer. A Pan-European Prospective Multicenter Double Single Arm Cohort Study.
Fondazione Poliambulanza Istituto Ospedaliero
400 participants
Jul 1, 2023
OBSERVATIONAL
Conditions
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
Inclusion Criteria7
- 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 Criteria17
- 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.
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Interventions
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.
or 8 CAPOX cycles (Arm 1) every 3 weeks.
Locations(1)
View Full Details on ClinicalTrials.gov
For the most up-to-date information, visit the official listing.
NCT06068023