Status:
RECRUITING
The ADAPTA Study: ADjuvant chemotherAPy After Curative Intent resecTion of Ampullary Cancer.
Lead Sponsor:
Fondazione Poliambulanza Istituto Ospedaliero
Collaborating Sponsors:
Associazione Italiana per la Ricerca sul Cancro
Conditions:
Ampullary Adenocarcinoma
Eligibility:
All Genders
18-100 years
Brief 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 sub...
Detailed Description
Background: Ampullary adenocarcinoma(AAC) is rare. 5-year survival rates of 30% to 70% are seen after resection. This broad range of survival could be explained by the morphological heterogeneity in ...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
July 1 2023
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
July 1 2029
Estimated Enrollment :
400 Patients enrolled
Trial Details
Trial ID
NCT06068023
Start Date
July 1 2023
End Date
July 1 2029
Last Update
October 5 2023
Active Locations (1)
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1
Fondazione Poliambulanza
Brescia, BS, Italy, 25124