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 Grading System
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Ovarian Cancer
- Sponsor
- M.D. Anderson Cancer Center
- Enrollment
- 241
- Locations
- 1
- Primary Endpoint
- 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.
- Status
- Completed
- Last Updated
- 13 years ago
Overview
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 Description
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).
Investigators
Eligibility Criteria
Inclusion Criteria
- •All patients enrolled on GOG protocol 158 with a diagnosis of serous carcinoma of the ovary.
Exclusion Criteria
- Not provided
Outcomes
Primary Outcomes
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
Secondary Outcomes
- 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)(2 Years)