Survival and Description of Care for Patients With Degenerate Vaterian Ampulloma
AMPULLOMA
Study of Survival and Description of Care for Patients With Degenerate Vaterian Ampulloma
1 other identifier
observational
402
1 country
36
Brief Summary
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.
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 2017
Longer than P75 for all trials
36 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
July 7, 2017
CompletedFirst Submitted
Initial submission to the registry
December 31, 2018
CompletedFirst Posted
Study publicly available on registry
January 11, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 15, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
December 15, 2022
CompletedMarch 24, 2022
March 1, 2022
5.4 years
December 31, 2018
March 23, 2022
Conditions
Outcome Measures
Primary Outcomes (1)
Overall survival
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 Outcomes (2)
RECURRENCE FREE SURVIVAL
3 years
PROGRESSION FREE SURVIVAL
5 years
Interventions
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).
Eligibility Criteria
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).
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (36)
Ch D'Abbeville
Abbeville, France
Chu Hotel Dieu
Angers, France
Ch Annecy Genevois
Annecy, France
Ch Cote Basque
Bayonne, France
Clinique Champeau
Béziers, France
Chu Saint Andre
Bordeaux, France
Polyclinique Bordeaux Nord Aquitaine
Bordeaux, France
Chu Estaing
Clermont-Ferrand, France
Hopitaux Civils de Colmar
Colmar, France
Ch - Sud Francilien
Corbeil-Essonnes, France
Chu Francois Mitterrand
Dijon, France
Chd Vendee
La Roche-sur-Yon, France
Le Kremlin Bicetre
Le Kremlin-Bicêtre, France
Chu Claude Huriez
Lille, France
Hôpital Dupuytren
Limoges, France
Ch Nord Essonne
Longjumeau, France
Chu La Croix Rousse
Lyon, France
Hcl Edouard Herriot
Lyon, France
Hcl Pierre Benite
Lyon, France
Hopital de La Timone
Marseille, France
Hopital Saint Joseph
Marseille, France
CH MACON
Mâcon, France
Ch de Meaux
Meaux, France
Chu Caremeau
Nîmes, France
Chr Orleans
Orléans, France
Chu Avicenne
Paris, France
Chu Cochin
Paris, France
Chu La Pitie Salpetriere
Paris, France
Hopital Europeen Georges Pompidou
Paris, France
Ch Saint Jean
Perpignan, France
CHU Hôpital de la Milétrie
Poitiers, France
Ch Cornouaille
Quimper, France
CH
Reims, France
Ch Saint Malo
St-Malo, France
CLINIQUE
Strasbourg, France
Ch Bretagne Atlantique
Vannes, France
Related Links
MeSH Terms
Interventions
Study Officials
- PRINCIPAL INVESTIGATOR
Julien TAIEB
Federation Francophone de Cancerologie Digestive
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
December 31, 2018
First Posted
January 11, 2019
Study Start
July 7, 2017
Primary Completion
December 15, 2022
Study Completion
December 15, 2022
Last Updated
March 24, 2022
Record last verified: 2022-03