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

Launched by FONDAZIONE POLIAMBULANZA ISTITUTO OSPEDALIERO · Oct 3, 2023

Keywords

ClinConnect Summary

The ADAPTA Study is researching the best ways to treat a rare type of cancer called ampullary adenocarcinoma (AAC) after surgery. The trial focuses on patients who have had their cancer removed but want to receive additional treatment to help prevent it from coming back. Depending on the specific type of AAC they have—either the more aggressive pancreatobiliary (PB) subtype or the intestinal subtype—participants will receive different chemotherapy treatments. The goal is to see if these tailored treatments can improve survival rates for patients with this challenging disease.

To participate in the study, individuals must be at least 18 years old, have a confirmed diagnosis of AAC that has been surgically treated without spreading to other parts of the body, and be able to start chemotherapy within eight weeks after surgery. They should also be in good overall health, as determined by their doctor. Participants can expect regular check-ups and treatment while being closely monitored for their health throughout the study. This trial is currently recruiting patients, and it aims to provide important insights into how to better treat ampullary cancer.

Gender

ALL

Eligibility criteria

• 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.