The ADAPTA Study: ADjuvant chemotherAPy After Curative Intent resecTion of Ampullary Cancer.

Recruiting now

Conditions studied: Ampullary Adenocarcinoma

In brief

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.

Key facts

Study ID

NCT06068023

Run by

Fondazione Poliambulanza Istituto Ospedaliero

People needed

400

Starts

2023-07-01

Expected to finish

2029-07-01

Last updated by the study team

2023-10-05

Who can join

Age: 18 and older, up to 100. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• 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

You may not qualify if…

• 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.

Where it is running

• Fondazione Poliambulanza — Brescia, BS, Italy (enrolling)

Full record on ClinicalTrials.gov

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