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

Gynecologic Oncology Group (GOG)

Status: Enrolling

Conditions: Stage IIIA Ovarian Cancer; Stage IV Ovarian Cancer; Stage IIIB Ovarian Cancer; Stage IIIC Ovarian Cancer

Treatments: Other: Laboratory Biomarker Analysis

Study type: Observational

Funder types: NETWORK; NIH

Identifiers

NCT01000259

U10CA027469 (U.S. NIH Grant/Contract)

CDR0000391277

NCI-2011-02279 (Registry Identifier)

GOG-8005

Details and patient eligibility

About

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.

Full 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.

Enrollment: 174 estimated patients

Sex: Female

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

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

Trial design

174 participants in 1 patient group

Ancillary-Correlative

Description:

Previously collected tumor tissue samples are analyzed for TIL via immunohistochemistry and double immunofluorescence assays using standard immunostaining.

Treatment:

Other: Laboratory Biomarker Analysis