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

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 Criteria:

* 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 Criteria:

* 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.

Conditions2

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