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

October 3, 2023 updated by: Fondazione Poliambulanza Istituto Ospedaliero

The ADAPTA Study: ADjuvant chemotherAPy After Curative Intent resecTion of Ampullary Cancer. A Pan-European Prospective Multicenter Double Single Arm Cohort Study.

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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.

Study Type

Observational

Enrollment (Estimated)

400

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Italy
    • BS
      • Brescia, BS, Italy, 25124
        • Recruiting
        • Fondazione Poliambulanza
        • Contact:
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Sampling Method

Non-Probability Sample

Study Population

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

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Intestinal-type ampullary adenocarcinoma intervention
This cohort consist of patients with intestinal-type ampullary adenocarcinoma who are able to receive adjuvant chemotherapy.
Drug: Capox
or 8 CAPOX cycles (Arm 1) every 3 weeks.
Other Names:
  • Capecitabine and oxaliplatin
Intestinal-type ampullary adenocarcinoma control
This cohort consist of patients with intestinal-type ampullary adenocarcinoma who are able to receive adjuvant chemotherapy but due to logistics or patient preference, are not willing to receive adjuvant chemotherapy.
Pancreatobiliary/mixed-type ampullary adenocarcinoma intervention
This cohort consist of patients with Pancreatobiliary/mixed-type ampullary adenocarcinoma who are able to receive adjuvant chemotherapy.
Drug: Folfirinox

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.

Other Names:
  • leucovorin calcium (folinic acid), fluorouracil, irinotecan hydrochloride, and oxaliplatin.
Pancreatobiliary/mixed-type ampullary adenocarcinoma control
This cohort consist of patients with Pancreatobiliary/mixed-type ampullary adenocarcinoma who are able to receive adjuvant chemotherapy but due to logistics or patient preference, are not willing to receive adjuvant chemotherapy.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Disease-free survival (3y)
Time Frame: 3 years
Disease-free survival (DFS) refers to the length of time after treatment for a disease in months, such as cancer, during which no signs or symptoms of the disease recur or progress. It is a crucial measure in assessing the effectiveness of a treatment regimen in preventing the return of the disease. In cancer contexts, DFS focuses on the period without disease recurrence or progression, highlighting the success of the treatment in controlling the illness.
3 years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Overall survival (3y)
Time Frame: 3 years
Overall survival (OS) is a critical medical outcome that measures the length of time in months from the start of treatment or diagnosis until a patient's death due to any cause. It provides a comprehensive view of the effectiveness of a treatment or intervention in extending a patient's life expectancy. OS is a fundamental endpoint in clinical trials and medical research, reflecting the real-world impact of medical strategies on patients' survival outcomes.
3 years
Disease-free survival (5y)
Time Frame: 5 years
Disease-free survival (DFS) refers to the length of time in months after treatment for a disease, such as cancer, during which no signs or symptoms of the disease recur or progress. It is a crucial measure in assessing the effectiveness of a treatment regimen in preventing the return of the disease. In cancer contexts, DFS focuses on the period without disease recurrence or progression, highlighting the success of the treatment in controlling the illness.
5 years
Overall survival (5y)
Time Frame: 5 years
Overall survival (OS) is a critical medical outcome that measures the length of time in months from the start of treatment or diagnosis until a patient's death due to any cause. It provides a comprehensive view of the effectiveness of a treatment or intervention in extending a patient's life expectancy. OS is a fundamental endpoint in clinical trials and medical research, reflecting the real-world impact of medical strategies on patients' survival outcomes.
5 years
Quality of Life questionnaire (qualitative outcome)
Time Frame: 3 years
Quality of life (QoL) is an essential outcome measure in clinical trials that assesses the overall well-being and satisfaction of patients throughout the course of a medical intervention or treatment. It encompasses various physical, emotional, social, and functional aspects of a patient's life, beyond just medical outcomes. QoL assessments provide valuable insights into how a treatment affects patients' daily functioning, emotional state, pain levels, social interactions, and overall sense of health and happiness. The questionnaires utilized in the ADAPTA study are the EQ-5D and the QLQ-C30.
3 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Fondazione Poliambulanza Istituto Ospedaliero

Collaborators

Associazione Italiana per la Ricerca sul Cancro

Investigators

  • Principal Investigator: Moh'd Abu Hilal, MD, PhD, Fondazione Poliambulanza Instituto Ospedaliero

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 1, 2023

Primary Completion (Estimated)

July 1, 2028

Study Completion (Estimated)

July 1, 2029

Study Registration Dates

First Submitted

August 29, 2023

First Submitted That Met QC Criteria

October 3, 2023

First Posted (Actual)

October 5, 2023

Study Record Updates

Last Update Posted (Actual)

October 5, 2023

Last Update Submitted That Met QC Criteria

October 3, 2023

Last Verified

October 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ADAPTA

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

IPD Plan Description

Upon reasonable request, the corresponding author can be contacted.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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