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

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

NCT ID: NCT06068023

Condition: Ampullary Adenocarcinoma

Conditions: Official terms:
Adenocarcinoma
Leucovorin
Capecitabine
Fluorouracil
Oxaliplatin
Irinotecan
Folfirinox
Levoleucovorin

Conditions: Keywords:
pancreatobiliary-type
intestinal-type
mixed/hybrid-type
adjuvant chemotherapy
CAPOX
FOLFIRINOX

Study type: Observational

Overall status: Recruiting

Study design:

Time perspective: Prospective

Intervention:

Intervention type: Drug
Intervention name: Folfirinox
Description: Patients meeting the criteria of post-operative adenocarcinoma of the ampulla of Vater will be enrolled, with adjuvant chemotherapy commencing within 8 weeks of recovery from surgery. Those undergoing palliative intent surgery or palliative chemotherapy are ineligible for the ADAPTA study. The ADAPTA study's adjuvant chemotherapy involves 8-12 FOLFIRINOX cycles (Arm 2) repeated 2 weeks. Given patient outcomes, 8 cycles of FOLFIRINOX are deemed sufficient due to completion challenges in prior research. FOLFIRINOX regimen mirrors the modified version from the ACCORD/PRODIGE trial for metastatic pancreatic cancer. This trial adapts mFOLFIRINOX for standard practice.
Arm group label: Pancreatobiliary/mixed-type ampullary adenocarcinoma intervention

Other name: leucovorin calcium (folinic acid), fluorouracil, irinotecan hydrochloride, and oxaliplatin.

Intervention type: Drug
Intervention name: Capox
Description: or 8 CAPOX cycles (Arm 1) every 3 weeks.
Arm group label: Intestinal-type ampullary adenocarcinoma intervention

Other name: Capecitabine and oxaliplatin

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.

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 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.

Criteria for eligibility:

Study pop:
Eligible patients are adult non-pregnant patients with a good WHO performance score and have (borderline) resectable non-metastatic ampullary cancer.

Sampling method: Non-Probability Sample
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.

Gender: All

Minimum age: 18 Years

Maximum age: 100 Years

Healthy volunteers: Accepts Healthy Volunteers

Locations:

Facility:
Name: Fondazione Poliambulanza

Address:
City: Brescia
Zip: 25124
Country: Italy

Status: Recruiting

Contact:
Last name: Moh'd Abu Hilal, MD, PhD

Phone: +393756326711
Email: basuijterwijk@live.nl

Contact backup:
Last name: Bas Uijterwijk, MD

Phone: 0640380827
Email: basuijterwijk@live.nl

Start date: July 1, 2023

Completion date: July 1, 2029

Lead sponsor:
Agency: Fondazione Poliambulanza Istituto Ospedaliero
Agency class: Other

Collaborator:
Agency: Associazione Italiana per la Ricerca sul Cancro
Agency class: Other

Source: Fondazione Poliambulanza Istituto Ospedaliero

Record processing date: ClinicalTrials.gov processed this data on November 12, 2024

Source: ClinicalTrials.gov page: https://clinicaltrials.gov/ct2/show/NCT06068023
https://isgaca.com/adapta/