Prognosis of Signet Ring Cells in Upper Digestive Neoplasms

Prognostic Clinical Trial

— ADCI001  

Official title:

Has the Quota of Signet Ring Cells an Influence on Prognosis and Treatment Strategy in the Upper GI Tract Adenocarcinomas?

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01249859
• Other study ID #: ADCI 001
• Status: Completed
• Phase: N/A
• First received: October 26, 2010
• Last updated: December 8, 2014
• Start date: March 2010
• Est. completion date: December 2010

Study information

• Verified date: December 2014
• Source: University Hospital, Lille
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: National Consultative Ethics Committee for Health and Life Sciences
• Study type: Observational

Clinical Trial Summary

Background • A major increase in incidence of signet ring cell adenocarcinomas (ADCI) of the upper digestive tract in western countries

• Discordant results in the literature concerning the prognosis value of the presence of signet ring cells.

• Preliminary data suggesting (i) an advanced stage at time of diagnosis, (ii) more often in the form of carcinose, (iii) a more pejorative prognosis, (iv) a recurrence more frequent, more quickly, and more often in the form of peritoneal carcinose, (v) a chemo resistance (vi) the need for a specific therapeutic strategy compared to non-signet ring cell adenocarcinomas.

Primary objective To test the hypothesis that 5-year survival rate is significantly lower in the signet ring cells (SRC) adenocarcinoma when compared to non-SRC adenocarcinoma in the upper digestive tract

Secondary objectives

• Impact of neoadjuvant CT on overall survival

• Impact and differential diagnostic value of linitis

• R0 resection rates

• 3 years recurrence free survival

• Overall 3 years survival

• Prognostic factors

• Prognostic value of the presence of a minority quota of signet ring cell

• Objective response rate after medical treatment (chemotherapy, radiochemotherapy) in non-resected patients

• Tolerance of (radio) chemotherapy for ADCI

Methodology Intention to treat retrospective case-control multicentric study A pairing on demographic criteria (age, sex, ASA score, center) and tumor criteria (TNM stage) will be done to ensure comparability in case control study groups.

Inclusion criteria All consecutive patients taken care of, for a proven histologically adenocarcinoma (ADCI and ADNCI) of the esophagus, the esogastric junction, or the stomach, in surgical or medical oncology investigator centers, will be saved in a given database.

For whom the first consultation took place between January 1997 and January 2010

Exclusion criteria Histological type other than adenocarcinoma Other localization than esogastric junction, esophagus or stomach

Planned study period The data will be collected over a period from January 1997 to January 2010.

The objective is to complete the data collection for summer 2010.

Description:

stomach cancer signet ring cell carcinoma prognosis chemotherapy

Recruitment information / eligibility

• Status: Completed
• Enrollment: 2500
• Est. completion date: December 2010
• Est. primary completion date: October 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 95 Years

Eligibility

Inclusion Criteria:

• All consecutive patients taken care of, for a proven histologically adenocarcinoma (ADCI and ADNCI) of the esophagus, the esogastric junction, or the stomach, in surgical or medical oncology investigator centers, will be saved in a given database.

• For whom the first consultation took place between January 1997 and January 2010

• As they benefit from a medical and/or surgical support (primitive cancer being or not resected), whatever the metastatic or the recurrence situation was.

Exclusion Criteria:

• Histological type other than adenocarcinoma

• Other localization than esogastric junction, esophagus or stomach

Study Design

Observational Model: Case Control, Time Perspective: Retrospective

Related Conditions & MeSH terms

• Case-control Study
• Oesophagus
• Prognostic
• Signet Ring Cell Carcinoma
• Stomach Disease
• Stomach Diseases

Locations

Country	Name	City	State
France	University Hospital of Lille	Lille

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Lille

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	To test the hypothesis that 5-year survival rate is significantly lower in the signet ring cells (SRC) adenocarcinoma when compared to non-SRC adenocarcinoma in the upper digestive tract		participants are followed until death or time point at 31 september 2010	No
Secondary	3 year recurrence free survival		participants are followed until recurrence or time point at 31 september 2010	No
Secondary	Overall 3 year survival according to tumor stage, node invasion, and tumor localization		participants are followed until death or time point at 31 september 2010	No