Actively Recruiting
The ADAPTA Study: ADjuvant chemotherAPy After Curative Intent resecTion of Ampullary Cancer.
Led by Fondazione Poliambulanza Istituto Ospedaliero · Updated on 2023-10-05
400
Participants Needed
1
Research Sites
313 weeks
Total Duration
On this page
Sponsors
F
Fondazione Poliambulanza Istituto Ospedaliero
Lead Sponsor
A
Associazione Italiana per la Ricerca sul Cancro
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
The ADAPTA Study: ADjuvant chemotherAPy After Curative Intent resecTion of Ampullary Cancer.
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Adult patients with confirmed ampullary adenocarcinoma subtyped as pancreatobiliary, mixed, or intestinal
- Patients who have had curative surgery for ampullary cancer without metastatic disease
- WHO performance status of 0 or 1
- Able and willing to receive adjuvant chemotherapy
- R0 or R1 surgical resection
- Age 18 years or older
- Provided written informed consent
You will not qualify if you...
- Previous radiotherapy, chemotherapy, or surgery for ampullary adenocarcinoma
- Past cancers (except non-melanoma skin cancer) diagnosed within 5 years before AAC diagnosis
- Pregnant women
- R2 resection (incomplete tumor removal)
- Starting adjuvant chemotherapy more than 12 weeks after surgery
- Serious other medical conditions that affect safety or study completion
- Known allergies or contraindications to capecitabine, 5-FU, irinotecan, or oxaliplatin
- Poor organ function including low white blood cells, neutrophils, platelets, hemoglobin
- Reduced kidney function (E-GFR < 50 ml/min or high serum creatinine)
- Significant liver problems indicated by high bilirubin, alkaline phosphatase, transaminases, or low albumin
- Blood clotting abnormalities not related to medication
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Fondazione Poliambulanza
Brescia, BS, Italy, 25124
Actively Recruiting
Research Team
M
Moh'd Abu Hilal, MD, PhD
CONTACT
B
Bas Uijterwijk
CONTACT
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
4
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