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AMPULLOMA
Study of Survival and Description of Care for Patients With Degenerate Vaterian Ampulloma
Sponsor study identifier
observational
402
1 country
36
Study Start
July 7, 2017
Actual (reported)Primary Completion
December 15, 2022
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Study Completion
December 15, 2022
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
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.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
December 15, 2022
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
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Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
July 7, 2017
Actual (reported)December 31, 2018
Actual (reported)January 11, 2019
Actual (reported)December 15, 2022
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
December 15, 2022
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
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
RECURRENCE FREE SURVIVAL
3 years
PROGRESSION FREE SURVIVAL
5 years
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).
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
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).
Ch D'Abbeville
Abbeville, France
Chu Hotel Dieu
Angers, France
Ch Annecy Genevois
Annecy, France
Julien TAIEB
Federation Francophone de Cancerologie Digestive
First Submitted
December 31, 2018
First Posted
January 11, 2019
Study Start
July 7, 2017
Actual (reported)Primary Completion
December 15, 2022
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Contact the study team to confirm eligibility.
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
Study Completion
December 15, 2022
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Last Updated
March 24, 2022
Record last verified: 2022-03
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Source: ClinicalTrials.gov.
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