Study of Tumor Tissue Samples From Patients Who Have Undergone Surgery for Advanced Stage III or Stage IV Ovarian Epithelial Cancer

Recruiting

• Conditions: Stage IIIB Ovarian Cancer; Stage IIIA Ovarian Cancer; Stage IIIC Ovarian Cancer; Stage IV Ovarian Cancer
• Interventions: Other: Laboratory Biomarker Analysis

• Registration Number: NCT01000259
• Lead Sponsor: Gynecologic Oncology Group

Brief Summary

This research study is looking at tumor tissue samples from patients who have undergone surgery for advanced stage III or stage IV ovarian epithelial cancer. Studying samples of tumor tissue from patients with cancer in the laboratory may help doctors learn how tumor infiltrating T cells can predict how patients will respond to treatment.

Detailed Description

PRIMARY OBJECTIVES:

I. To validate the ability of intratumoral tumor-infiltrating T lymphocytes (TILs) to predict progression-free survival (PFS) in patients with suboptimally debulked advanced stage III or IV ovarian epithelial cancer.

II. To validate the ability of intratumoral TILs to predict PFS in patients with optimally debulked disease.

SECONDARY OBJECTIVES:

I. To validate the ability of intratumoral TILs to predict overall survival of patients with suboptimally debulked disease.

II. To validate the ability of intratumoral TILs to predict overall survival of patients with optimally debulked disease.

OUTLINE:

Patients are stratified according to status of debulked disease (suboptimal vs optimal).

Previously collected tumor tissue samples are analyzed for tumor-infiltrating lymphocytes (TIL) via immunohistochemistry and double immunofluorescence assays using standard immunostaining.

Study Timeline

• Study Start: 2004-09
• Study First Submitted: 2009-10-22
• Study First Submitted QC: 2009-10-22
• Study First Posted: 2009-10-23
• Status Verified: 2017-05
• Last Update Submitted: 2017-05-02
• Last Update Posted: 2017-05-05
• Primary Completion: 2100-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: Female
• Target Recruitment: 174

Inclusion Criteria

• Diagnosis of stage III or IV ovarian epithelial cancer and enrolled on Gynecologic Oncology Group (GOG)-0136 and a GOG front-line platinum/taxol chemotherapy trial (GOG-0114, GOG-132, GOG-0158, or GOG-0162)

• Must have fixed and paraffin-embedded tissue from primary surgery available from 1 of the following sources:

  • Patients enrolled on GOG-0136 and a GOG front-line platinum/taxol chemotherapy trial(GOG-0114, GOG-0132, GOG-0158, and GOG-0162)
  • Patients who have had either optimal or suboptimal cytoreductive surgery
  • Patients for whom adequate demographic data, including major prognostic factors and follow-up information, were collected

• Evaluable patients must have had measurable or nonmeasurable disease

• Demographic and follow-up data available

Exclusion Criteria

Not provided

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Ancillary-Correlative	Laboratory Biomarker Analysis	Previously collected tumor tissue samples are analyzed for TIL via immunohistochemistry and double immunofluorescence assays using standard immunostaining.

Primary Outcome Measures

Name	Time	Method
Progression-free survival curves	Baseline	The Kaplan-Meier method will be used to estimate the survival curves, and the log-rank test will be used to test the difference between survival curves for TIL positive and negative patients. All of the tests will be two-sided and the significant levels will be set a 0.05.
Overall survival curves	Baseline	The Kaplan-Meier method will be used to estimate the survival curves, and the log-rank test will be used to test the difference between survival curves for TIL positive and negative patients. All of the tests will be two-sided and the significant levels will be set a 0.05.

Trial Locations

Locations (1)

Gynecologic Oncology Group; 🇺🇸 Philadelphia, Pennsylvania, United States