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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03800212
Recruitment Status : Recruiting
First Posted : January 11, 2019
Last Update Posted : January 11, 2019
Sponsor:
Information provided by (Responsible Party):
Federation Francophone de Cancerologie Digestive

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.

Condition or disease Intervention/treatment
Ampullary Adenocarcinoma Drug: treatment for ampullary adenocarcinoma

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Study Type : Observational
Estimated Enrollment : 402 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Study of Survival and Description of Care for Patients With Degenerate Vaterian Ampulloma
Actual Study Start Date : July 7, 2017
Estimated Primary Completion Date : December 15, 2021
Estimated Study Completion Date : December 15, 2022

Intervention Details:
  • Drug: treatment for ampullary adenocarcinoma
    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).
    Other Name: no other intervention name to add


Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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.

  2. 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.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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).
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03800212


Contacts
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Contact: Julien TAIEB, Pr 01 56 09 35 56 ext +33 jtaieb75@gmail.com

Locations
Show Show 36 study locations
Sponsors and Collaborators
Federation Francophone de Cancerologie Digestive
Investigators
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Principal Investigator: Julien TAIEB Federation Francophone de Cancerologie Digestive

Additional Information:
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Responsible Party: Federation Francophone de Cancerologie Digestive
ClinicalTrials.gov Identifier: NCT03800212    
Other Study ID Numbers: AMPULLOMA COHORT
First Posted: January 11, 2019    Key Record Dates
Last Update Posted: January 11, 2019
Last Verified: December 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Adenocarcinoma
Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms