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

Phase

N/A

Condition

Adenocarcinoma

Treatment

Folfirinox

Capox

Clinical Study ID

NCT06068023

ADAPTA

Ages 18-100
All Genders
Accepts Healthy Volunteers

Study 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 Criteria

Inclusion

Inclusion Criteria:

Adult patients with histologically or cytologically confirmed AAC with subtyping ofpancreatobiliary/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

Exclusion Criteria:

Prior radiotherapy, chemotherapy, or resection for AAC.
Previous malignancy (excluding non-melanoma skin cancer), unless no evidence ofdisease 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 8weeks)
Serious concomitant systemic disorders that would compromise the safety of the patientor his/her ability to complete the study, at the discretion of the investigator.
Known hypersensitivity or contraindications against capecitabine, 5 FU, Irinotecan, orOxaliplatin
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 > 3xUNL (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 absenceof any drugs interfering with coagulation such as acenocoumarin, warfarin,phenprocoumon, NMH or UFH.

Study Design

Folfirinox

July 01, 2023

July 01, 2029

Study 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 the three subtypes of AAC (pancreatobiliary, intestinal and mixed subtype), which complicates the prediction of individual prognosis and clinical decision making with regard to adjuvant therapy. To date there are no prospective studies to elucidate whether adjuvant chemotherapy improves survival in these patients.

Methods/design:

The ADAPTA study is a phase II prospective single arm multicenter cohort study including 200 patients with resected AAC (100 patients with intestinal subtype, and 100 with pancreatobiliary- and mixed subtype). All patients will be treated with CAPOX/ FOLFIRINOX respectively. Outcomes will be compared after propensity score matching to data of all patients in consecutive participating centers not treated according to the proposed regime.

Connect with a study center

Fondazione Poliambulanza
Brescia, BS 25124
Italy
Active - Recruiting

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