Clinical Trial: Prognosis of Signet Ring Cells in Upper Digestive Neoplasms
Study Status: Completed
Recruit Status: Completed
Study Type: Observational
Official Title: Has the Quota of Signet Ring Cells an Influence on Prognosis and Treatment Strategy in the Upper GI Tract Adenocarcinomas?
Brief 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-
Detailed Summary: stomach cancer signet ring cell carcinoma prognosis chemotherapy
Sponsor: University Hospital, Lille
Current Primary Outcome: 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 [ Time Frame: participants are followed until death or time point at 31 september 2010 ]
Original Primary Outcome: Same as current
Current Secondary Outcome:
- 3 year recurrence free survival [ Time Frame: participants are followed until recurrence or time point at 31 september 2010 ]
- Overall 3 year survival according to tumor stage, node invasion, and tumor localization [ Time Frame: participants are followed until death or time point at 31 september 2010 ]
Original Secondary Outcome: Same as current
Information By: University Hospital, Lille
Dates:
Date Received: October 26, 2010
Date Started: March 2010
Date Completion:
Last Updated: December 8, 2014
Last Verified: December 2014