Clinical Trial: Ancillary Study GOG 158: Survival Analysis Based on Reclassification to a Two-Tier Grading System

Study Status: Completed
Recruit Status: Completed
Study Type: Observational

Official Title: An Ancillary Study of Patients With Advanced Stage Serous Carcinoma of the Ovary Treated on GOG Protocol 158: A Survival Analysis Based on Reclassification to a Two-tier G

Brief Summary:

Primary Objective:

  • To reclassify the histologic grade of the serous ovarian cancer specimens of patients enrolled on Gynecologic Oncology Group (GOG) protocol 158 using a two-tier system.

Secondary Objective:

  • To determine the overall and progression-free survival of patients with serous carcinoma of the ovary treated on GOG protocol 158 when reclassified according to tumor grade (low vs. high).

Tertiary Objective:

  • To correlate histologic grade with other prognostic factors.

Detailed Summary: The purpose of this study is to describe the progression-free and overall survival of patients treated on GOG protocol 158 when their tumors are reclassified into a two-tier grading system. Although no universal grading system exists, Malpica et al. have recently published data on a clinically meaningful two-tier grading system for serous ovarian carcinoma (Malpica et al., American Journal of Surgical Pathology, 2004). Tumor grade has been shown to be an important prognostic factor in women with epithelial ovarian cancer, especially in early stage carcinomas. While there is less consensus regarding the prognostic significance of grade in late stage tumors, researchers have noted that patients with low-grade advanced disease may have a longer survival than those with high-grade lesions (Bodurka-Bevers et al., Gynecologic Oncology, 2000).
Sponsor: M.D. Anderson Cancer Center

Current Primary Outcome: Reclassification of histologic grade of the serous ovarian cancer specimens of patients enrolled on Gynecologic Oncology Group (GOG) protocol 158 using a two-tier system. [ Time Frame: 2 Years ]

Original Primary Outcome: To reclassify the histologic grade of the serous ovarian cancer specimens of patients enrolled on Gynecologic Oncology Group (GOG) protocol 158 using a two-tier system. [ Time Frame: 2 Years ]

Current Secondary Outcome: Overall and Progression-free survival of patients with serous carcinoma of the ovary treated on GOG protocol 158 when reclassified according to tumor grade (low vs. high) [ Time Frame: 2 Years ]

Original Secondary Outcome: To determine the overall and progression-free survival of patients with serous carcinoma of the ovary treated on GOG protocol 158 when reclassified according to tumor grade (low vs. high). [ Time Frame: 2 Years ]

Information By: M.D. Anderson Cancer Center

Dates:
Date Received: February 5, 2009
Date Started: August 2007
Date Completion:
Last Updated: December 20, 2012
Last Verified: December 2012