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.
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
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.
Eligible patients are adult non-pregnant patients with a good WHO performance score and have (borderline) resectable non-metastatic ampullary cancer.
Case-control
Prospective
Folfirinox
DrugPatients 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
Drugor 8 CAPOX cycles (Arm 1) every 3 weeks.
Disease-free survival (3y)
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.
Overall survival (3y)
Overall survival (OS) is a critical medical outcome that measures the length of time in months from the start of treatment or diagnosis until a patient's death due to any cause. It provides a comprehensive view of the effectiveness of a treatment or intervention in extending a patient's life expectancy. OS is a fundamental endpoint in clinical trials and medical research, reflecting the real-world impact of medical strategies on patients' survival outcomes.
Disease-free survival (5y)
Disease-free survival (DFS) refers to the length of time in months after treatment for a disease, 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.
Overall survival (5y)
Overall survival (OS) is a critical medical outcome that measures the length of time in months from the start of treatment or diagnosis until a patient's death due to any cause. It provides a comprehensive view of the effectiveness of a treatment or intervention in extending a patient's life expectancy. OS is a fundamental endpoint in clinical trials and medical research, reflecting the real-world impact of medical strategies on patients' survival outcomes.
Quality of Life questionnaire (qualitative outcome)
Quality of life (QoL) is an essential outcome measure in clinical trials that assesses the overall well-being and satisfaction of patients throughout the course of a medical intervention or treatment. It encompasses various physical, emotional, social, and functional aspects of a patient's life, beyond just medical outcomes. QoL assessments provide valuable insights into how a treatment affects patients' daily functioning, emotional state, pain levels, social interactions, and overall sense of health and happiness. The questionnaires utilized in the ADAPTA study are the EQ-5D and the QLQ-C30.
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Fondazione Poliambulanza Istituto Ospedaliero
Lead sponsor
Associazione Italiana per la Ricerca sul Cancro
Collaborator
