NCT01166737

Study Comparing Tumor Debulking Surgery Versus Chemotherapy Alone in Recurrent Platinum-Sensitive Ovarian Cancer

A Randomized Multicenter Study to Compare the Efficacy of Additional Tumor Debulking Surgery vs Chemotherapy Alone in Recurrent Platinum-Sensitive Ovarian Cancer

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 408 (actual)
• Sponsor: AGO Study Group · Academic / Other
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

It is still not clear whether a positive AGO-score just selects patients with less aggressive biologic tumor behavior who as well would have had a positive outcome by chemotherapy only, or , if it is a score selecting patients who really benefit from surgery. Nevertheless, the AGO-score was confirmed to select patients with a less than 30% risk of ending with residual tumor after surgery for recurrent disease. This could avoid including patients into the present surgical protocol who could not benefit from an operationThe goal of this third DESKTOP study is to evaluate in a prospectively randomized multicentre setting, whether maximum effort of cytoreductive surgery followed by platinum based combination chemotherapy can improve overall survival as compared to platinum based combination chemotherapy alone in AGO-score positive patients.

Detailed description

A predictive score identifying patients who might achieve a complete resection is deemed necessary to select the right patients for a prospective trial on cytoreductive surgery in relapsed ovarian cancer. Study centres are selected due to their surgical experience in ovarian cancer and/or participation in prior surgical trials in this field. Patients who matched eligibility criteria were allocated randomly 1:1 prospectively to cytoreductive surgery followed by platinum based combination chemotherapy or to platinum based combination chemotherapy alone .

Conditions

• Fallopian Tube Cancer
• Ovarian Cancer
• Peritoneal Cavity Cancer

Interventions

Type	Name	Description
PROCEDURE	Tumor Debulking Surgery (surgery in recurrent ovarian disease)	Surgery for Patients with platinum-sensitive recurrent ovarian cancer with a positive AGO-score predictive for complete tumor resection

Timeline

• Start date: 2010-07-01
• Primary completion: 2020-01-17
• Completion: 2020-12-31
• First posted: 2010-07-21
• Last updated: 2022-01-25

Locations

86 sites across 12 countries: Austria, Belgium, China, Denmark, France, Germany, Italy, Norway, South Korea, Spain, Sweden, United Kingdom