Survival and Description of Care for Patients With Degenerate Vaterian Ampulloma (AMPULLOMA)

March 23, 2022 updated by: Federation Francophone de Cancerologie Digestive

Study of Survival and Description of Care for Patients With Degenerate Vaterian Ampulloma

A Vater's ampulloma is a rare digestive tumour which accounts for under 1% of all digestive tumours. The only curative treatment is complete excision (surgical or endoscopic) of the lesions which is possible in 80% of cases , with or without adjuvant treatment. The reference radical treatment is cephalic duodenopancreatectomy (CDP). The indication for adjuvant treatment is still debated: in view of the aggressive nature of the disease and the high recurrence rate, it would appear appropriate to offer adjuvant treatment, although several studies have failed to find any benefit on survival with post-operative radio-chemotherapy, the most widely studied treatment at present, compared to excision alone. At present there are no phase II studies specifically examining medical treatment of degenerated, inoperable Vater's ampullomas. Some groups propose chemotherapies with 5-FU or gemcitabine, analogous to the treatments used for intestinal, pancreatic or biliary tumours, although neither one has been shown to date to be superior to the other, nor have decision-making criteria been clearly established.In conclusion, a national cohort study is proposed to undertake a prospective analysis of the outcome of all patients treated for ampullary adenocarcinoma (particularly survival without recurrence and prognostic indicators for excised tumours and the duration of disease control for tumours treated with palliative chemotherapy). The treatment methods will be left to the free choice of the investigator and all patients may be included, regardless of stage of their disease. In this study, freezing of tumour fragments is encouraged, as this cohort will be supplemented by a later biological study. In order to recruit sufficient patient numbers, the study will be based on participation of the cooperative groups involved in the management of digestive cancers.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

A Vater's ampulloma is a rare digestive tumour which accounts for under 1% of all digestive tumours. In terms of incidence, it is the 3rd most common biliary tract tumour after gallbladder cancer and common bile duct cancer. The incidence of ampullary adenocarcinoma is not well known although it is estimated to be around 0.49 per 100,000 people. The known risk factors are familial adenomatous polyposis (FAP) and Gardner's syndrome, HNPCC (Hereditary Non-Polyposis Colorectal Cancer) syndrome, Peutz-Jeghers syndrome, Crohn's disease and coeliac disease.

Except in its highly localised forms, ampulla of Vater carcinoma carries a poor prognosis. It is a highly lymphophilic disease which commonly metastasises, particularly to the lymph nodes and liver. The prognosis is however considerably better than that of pancreatic adenocarcinoma. In one study which compared 71 ampullomas with 144 adenocarcinomas of pancreatic head, the 5-year survival was 60% for the ampullary carcinomas compared to 20% for pancreatic adenocarcinomas.

More generally, the 5-year survival rate in the literature is between 40-60% and, depending on the study, 10-year survival is approximately 38% .

The only curative treatment is complete excision (surgical or endoscopic) of the lesions which is possible in 80% of cases , with or without adjuvant treatment. The reference radical treatment is cephalic duodenopancreatectomy (CDP). The 5-year survival rate in cases of adenocarcinoma excised by CPD is in the region of 50%, rising to 60-70% if no lymph node invasion is present, compared to 30% when lymph nodes are invaded and median survival is approximately 4.5 years .

The indication for adjuvant treatment is still debated: in view of the aggressive nature of the disease and the high recurrence rate, it would appear appropriate to offer adjuvant treatment, although several studies have failed to find any benefit on survival with post-operative radio-chemotherapy, the most widely studied treatment at present, compared to excision alone . There is only one single randomised study comparing these two forms of management, which shows no benefit in terms of 2 and 5-year survival, although only a small number of patients had an ampullary tumour in this study . The conclusions of several retrospective studies are more subtle, showing results in favour of adjuvant treatment in patients with lymph node disease or a large tumour (T3/T4) .

Some groups have tested the merits of peroperative irradiation. It would appear that this technique does not improve survival, although data on this subject are extremely patchy .

Administration of exclusive adjuvant chemotherapy has been examined in a single randomised study. In this phase III study (ESPAC 3), median overall survival of patients who received adjuvant chemotherapy with FUFOL Mayo for 6 months (n=101) or gemcitabine (n=98) was not significantly improved compared to survival in patients undergoing surgery and not receiving complementary treatment (57.1 versus 43 months, HR= 0.85, p=0.32). A subgroup analysis suggested that the benefit of chemotherapy could be greater in the subgroup of patients with RO resection (p= 0.057, 91% of cases).

Mean survival in patients suffering inoperable tumours is between 9 and 20.4 months depending on the study .

It should be noted however that most of these studies have included tumours other than ampullomas (particularly small bowel adenocarcinomas), making it more difficult to interpret these results, and also that many are old results dating from before the era of modern chemotherapies.

At present there are no phase II studies specifically examining medical treatment of degenerated, inoperable Vater's ampullomas. Some groups propose chemotherapies with 5-FU or gemcitabine, analogous to the treatments used for intestinal, pancreatic or biliary tumours, although neither one has been shown to date to be superior to the other, nor have decision-making criteria been clearly established. One phase II study published in 2009 proposed CAPOX as the reference treatment in light of the promising results obtained. Patients suffering from ampullary cancer in this study however were combined with patients who were suffering from small bowel adenocarcinoma.

In conclusion, a national cohort study is proposed to undertake a prospective analysis of the outcome of all patients treated for ampullary adenocarcinoma (particularly survival without recurrence and prognostic indicators for excised tumours and the duration of disease control for tumours treated with palliative chemotherapy). The treatment methods will be left to the free choice of the investigator and all patients may be included, regardless of stage of their disease. In this study, freezing of tumour fragments is encouraged, as this cohort will be supplemented by a later biological study. In order to recruit sufficient patient numbers, the study will be based on participation of the cooperative groups involved in the management of digestive cancers.

Study Type

Observational

Enrollment (Anticipated)

402

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 Locations

  • France
      • Abbeville, France
        • Recruiting
        • CH d'Abbeville
        • Contact:
          • JOEL BUTEL
      • Angers, France
        • Recruiting
        • CHU Hôtel Dieu
        • Contact:
          • NATHALIE BAIZE
      • Annecy, France
        • Recruiting
        • CH Annecy Genevois
        • Contact:
          • ROMAN COMBES
      • Bayonne, France
        • Recruiting
        • CH Cote Basque
        • Contact:
          • Franck AUDEMAR
      • Bordeaux, France
        • Recruiting
        • Polyclinique Bordeaux Nord Aquitaine
        • Contact:
          • BALHADERE
      • Bordeaux, France
        • Recruiting
        • CHU Saint Andre
        • Contact:
          • CHABRUN
      • Béziers, France
        • Recruiting
        • Clinique Champeau
        • Contact:
          • MICHAEL HUMMELSBERGER
      • Clermont-Ferrand, France
        • Recruiting
        • Chu Estaing
        • Contact:
          • DENIS PEZET
      • Colmar, France
        • Recruiting
        • Hôpitaux Civils de Colmar
        • Contact:
          • LAURIANNE PLASTARAS
        • Sub-Investigator:
          • CAMARA
        • Sub-Investigator:
          • BREYSACHER
      • Corbeil-Essonnes, France
        • Recruiting
        • CH - Sud Francilien
        • Contact:
          • Samy LOUAFI
      • Dijon, France
        • Recruiting
        • CHU Francois Mitterrand
        • Contact:
          • Sylvain MANFREDI
        • Sub-Investigator:
          • ANTOINE DROUILLARD
        • Sub-Investigator:
          • JEAN LOUIS JOUVE
      • La Roche-sur-Yon, France
        • Recruiting
        • CHD Vendee
        • Contact:
          • MORGAN AMIL
        • Sub-Investigator:
          • RAME
        • Sub-Investigator:
          • LALY
      • Le Kremlin-Bicêtre, France
        • Recruiting
        • Le Kremlin Bicetre
        • Contact:
          • Stéphane BENOIST
      • Lille, France
        • Recruiting
        • CHU Claude Huriez
        • Contact:
          • christophe MARIETTE
        • Sub-Investigator:
          • GUILLAUME PIESSEN
      • Limoges, France
        • Recruiting
        • Hôpital Dupuytren
        • Contact:
          • STEPHANE BOUVIER
      • Longjumeau, France
        • Recruiting
        • Ch Nord Essonne
        • Contact:
          • YOUNES ZEKRI
      • Lyon, France
        • Recruiting
        • CHU la Croix Rousse
        • Contact:
          • MARIELLE GUILLET
      • Lyon, France
        • Recruiting
        • HCL Edouard Herriot
        • Contact:
          • MUSTAPHA ADHAM
        • Sub-Investigator:
          • GRAILLOT
      • Lyon, France
        • Recruiting
        • Hcl Pierre Benite
        • Contact:
          • OLIVIER GLEHEN
      • Marseille, France
        • Recruiting
        • hopital de la Timone
        • Contact:
          • MARINE BARRAUD BLANC
      • Marseille, France
        • Recruiting
        • Hôpital Saint Joseph
        • Contact:
          • Hervé PERRIER
      • Meaux, France
        • Recruiting
        • CH de Meaux
        • Contact:
          • CHRISTOPHE LOCHER
      • Mâcon, France
        • Recruiting
        • CH Mâcon
        • Contact:
          • MARIE MARTIN BELLECOSTE
      • Nîmes, France
        • Recruiting
        • CHU Caremeau
        • Contact:
          • CLAIRE PHILIPPE
      • Orléans, France
        • Recruiting
        • CHR Orléans
        • Contact:
          • BRAHIM OUAHRANI
      • Paris, France
        • Recruiting
        • CHU Avicenne
        • Contact:
          • THOMAS APARICIO
      • Paris, France
        • Recruiting
        • CHU Cochin
        • Contact:
          • Romain CORIAT
        • Sub-Investigator:
          • CROMBE
      • Paris, France
        • Recruiting
        • CHU La Pitié Salpêtrière
        • Contact:
          • JEAN BAPTISTE BACHET
      • Paris, France
        • Recruiting
        • Hôpital Européen Georges Pompidou
        • Contact:
          • ORIANNE COLUSSI
        • Sub-Investigator:
          • PERKINS
      • Perpignan, France
        • Recruiting
        • CH Saint Jean
        • Contact:
          • FAIZA KHEMISSA AKOUZ
      • Poitiers, France
      • Quimper, France
        • Recruiting
        • Ch Cornouaille
        • Contact:
          • KARINE BIDEAU
      • Reims, France
      • Saint-Malo, France
        • Recruiting
        • CH Saint Malo
        • Contact:
          • ROMAIN DESGRIPPES
      • Strasbourg, France
        • Recruiting
        • Clinique
        • Contact:
          • Youssef TAZI
      • Vannes, France
        • Recruiting
        • CH Bretagne Atlantique
        • Contact:
          • DENIS GRASSET

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

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

all patients treated for ampullary adenocarcinoma (particularly survival without recurrence and prognostic indicators for excised tumours and the duration of disease control for tumours treated with palliative chemotherapy).

Description

Inclusion Criteria:

  • Patients aged 18 years and older.
  • Histologically-proven adenocarcinoma of the ampulla of Vater which is operable or with locoregional or metastatic recurrence after excision less than 6 months previously.

Exclusion Criteria:

  • Patients who cannot be followed up regularly for psychological, social, family or geographical reasons.
  • Non-ampullary tumours.
  • Non-adenocarcinomatous ampullary tumours.
  • Ampullary adenocarcinomas which are metastatic or locally advanced from the outset and inoperable.

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

  • Observational Models: Cohort
  • Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Overall survival
Time Frame: 5 years
The time interval between the date of diagnosis of the disease and date of death (all causes). Patients who are alive will be censured at the date of last news.
5 years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
RECURRENCE FREE SURVIVAL
Time Frame: 3 years
The time interval between the date of diagnosis of the disease and the date of the recurrence or death (all causes). Patients who are alive without recurrence will be censured at the date of last news.
3 years
PROGRESSION FREE SURVIVAL
Time Frame: 5 years
Time interval between the date of starting treatment and the date of first progression (local or remote, clinical or radiological) or death (all causes). Patients who are alive without progression will be censured at the date of last news. Radiological progression will be defined according to RECIST version 1.1 criteria.
5 years

Collaborators and Investigators

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

Sponsor

Federation Francophone de Cancerologie Digestive

Investigators

  • Principal Investigator: Julien TAIEB, Federation Francophone de Cancerologie Digestive

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.

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 7, 2017

Primary Completion (Anticipated)

December 15, 2022

Study Completion (Anticipated)

December 15, 2022

Study Registration Dates

First Submitted

December 31, 2018

First Submitted That Met QC Criteria

January 8, 2019

First Posted (Actual)

January 11, 2019

Study Record Updates

Last Update Posted (Actual)

March 24, 2022

Last Update Submitted That Met QC Criteria

March 23, 2022

Last Verified

March 1, 2022

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • AMPULLOMA COHORT

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Undecided

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

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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