The ADAPTA Study: ADjuvant chemotherAPy After Curative Intent resecTion of Ampullary Cancer.
ADAPTA
1 other identifier
observational
400
1 country
1
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Jul 2023
Longer than P75 for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
July 1, 2023
CompletedFirst Submitted
Initial submission to the registry
August 29, 2023
CompletedFirst Posted
Study publicly available on registry
October 5, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 1, 2028
ExpectedStudy Completion
Last participant's last visit for all outcomes
July 1, 2029
October 5, 2023
October 1, 2023
5 years
August 29, 2023
October 3, 2023
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Disease-free survival (3y)
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 Outcomes (4)
Overall survival (3y)
3 years
Disease-free survival (5y)
5 years
Overall survival (5y)
5 years
Quality of Life questionnaire (qualitative outcome)
3 years
Study Arms (4)
Intestinal-type ampullary adenocarcinoma intervention
This cohort consist of patients with intestinal-type ampullary adenocarcinoma who are able to receive adjuvant chemotherapy.
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.
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.
Interventions
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.
or 8 CAPOX cycles (Arm 1) every 3 weeks.
Eligibility Criteria
Eligible patients are adult non-pregnant patients with a good WHO performance score and have (borderline) resectable non-metastatic ampullary cancer.
You may qualify if:
- 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
You may not qualify if:
- 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
- +2 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Fondazione Poliambulanza
Brescia, BS, 25124, Italy
Related Publications (6)
Zhou J, Hsu CC, Winter JM, Pawlik TM, Laheru D, Hughes MA, Donehower R, Wolfgang C, Akbar U, Schulick R, Cameron J, Herman JM. Adjuvant chemoradiation versus surgery alone for adenocarcinoma of the ampulla of Vater. Radiother Oncol. 2009 Aug;92(2):244-8. doi: 10.1016/j.radonc.2009.05.006. Epub 2009 Jun 21.
PMID: 19541379BACKGROUNDNeoptolemos JP, Moore MJ, Cox TF, Valle JW, Palmer DH, McDonald AC, Carter R, Tebbutt NC, Dervenis C, Smith D, Glimelius B, Charnley RM, Lacaine F, Scarfe AG, Middleton MR, Anthoney A, Ghaneh P, Halloran CM, Lerch MM, Olah A, Rawcliffe CL, Verbeke CS, Campbell F, Buchler MW; European Study Group for Pancreatic Cancer. Effect of adjuvant chemotherapy with fluorouracil plus folinic acid or gemcitabine vs observation on survival in patients with resected periampullary adenocarcinoma: the ESPAC-3 periampullary cancer randomized trial. JAMA. 2012 Jul 11;308(2):147-56. doi: 10.1001/jama.2012.7352.
PMID: 22782416BACKGROUNDBolm L, Ohrner K, Nappo G, Ruckert F, Zimmermann C, Rau BM, Petrova E, Honselmann KC, Lapshyn H, Bausch D, Weitz J, Sandini M, Keck T, Zerbi A, Distler M, Wellner UF. Adjuvant therapy is associated with improved overall survival in patients with pancreatobiliary or mixed subtype ampullary cancer after pancreatoduodenectomy - A multicenter cohort study. Pancreatology. 2020 Apr;20(3):433-441. doi: 10.1016/j.pan.2020.01.009. Epub 2020 Jan 21.
PMID: 31987649BACKGROUNDConroy T, Hammel P, Hebbar M, Ben Abdelghani M, Wei AC, Raoul JL, Chone L, Francois E, Artru P, Biagi JJ, Lecomte T, Assenat E, Faroux R, Ychou M, Volet J, Sauvanet A, Breysacher G, Di Fiore F, Cripps C, Kavan P, Texereau P, Bouhier-Leporrier K, Khemissa-Akouz F, Legoux JL, Juzyna B, Gourgou S, O'Callaghan CJ, Jouffroy-Zeller C, Rat P, Malka D, Castan F, Bachet JB; Canadian Cancer Trials Group and the Unicancer-GI-PRODIGE Group. FOLFIRINOX or Gemcitabine as Adjuvant Therapy for Pancreatic Cancer. N Engl J Med. 2018 Dec 20;379(25):2395-2406. doi: 10.1056/NEJMoa1809775.
PMID: 30575490BACKGROUNDOverman MJ, Varadhachary GR, Kopetz S, Adinin R, Lin E, Morris JS, Eng C, Abbruzzese JL, Wolff RA. Phase II study of capecitabine and oxaliplatin for advanced adenocarcinoma of the small bowel and ampulla of Vater. J Clin Oncol. 2009 Jun 1;27(16):2598-603. doi: 10.1200/JCO.2008.19.7145. Epub 2009 Jan 21.
PMID: 19164203BACKGROUNDMoekotte AL, Malleo G, van Roessel S, Bonds M, Halimi A, Zarantonello L, Napoli N, Dreyer SB, Wellner UF, Bolm L, Mavroeidis VK, Robinson S, Khalil K, Ferraro D, Mortimer MC, Harris S, Al-Sarireh B, Fusai GK, Roberts KJ, Fontana M, White SA, Soonawalla Z, Jamieson NB, Boggi U, Alseidi A, Shablak A, Wilmink JW, Primrose JN, Salvia R, Bassi C, Besselink MG, Abu Hilal M. Gemcitabine-based adjuvant chemotherapy in subtypes of ampullary adenocarcinoma: international propensity score-matched cohort study. Br J Surg. 2020 Aug;107(9):1171-1182. doi: 10.1002/bjs.11555. Epub 2020 Apr 7.
PMID: 32259295BACKGROUND
Related Links
Biospecimen
The analysis of the molecular markers through the genetic test of tumor samples will be performed (substudy).
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Moh'd Abu Hilal, MD, PhD
Fondazione Poliambulanza Instituto Ospedaliero
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- CASE CONTROL
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
August 29, 2023
First Posted
October 5, 2023
Study Start
July 1, 2023
Primary Completion (Estimated)
July 1, 2028
Study Completion (Estimated)
July 1, 2029
Last Updated
October 5, 2023
Record last verified: 2023-10