NCT01611766

Surgery or Chemotherapy in Recurrent Ovarian Cancer (SOC 1 Trial)?

Evaluation of Secondary Cytoreductive Surgery in Platinum-Sensitive Recurrent Ovarian Cancer: A Phase III, Multicenter, Randomized Trial

• Status: Unknown
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 356 (estimated)
• Sponsor: Shanghai Gynecologic Oncology Group · Other Government
• Sex: Female
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to evaluate the role of secondary cytoreduction (SCR) and validate the risk model of patient selection criteria in platinum-sensitive recurrent ovarian cancer.

Detailed description

The primary objective is to determine whether secondary cytoreduction followed by chemotherapy is superior to chemotherapy alone in improving progression-free survival (PFS) and overall survival (OS) in patients with platinum-sensitive recurrent ovarian cancer

Conditions

• Ovarian Epithelial Cancer Recurrent
• Fallopian Tube Carcinoma
• Primary Peritoneal Carcinoma

Interventions

Type	Name	Description
PROCEDURE	Secondary Cytoreductive Surgery	Complete Cytoreduction
DRUG	Salvage Chemotherapy	6 cycles of postoperative chemotherapy

Timeline

• Start date: 2012-07-19
• Primary completion: 2019-12-01
• Completion: 2022-12-01
• First posted: 2012-06-05
• Last updated: 2021-06-10

Locations

4 sites across 1 country: China