NCT01483443

Oophorectomy Followed by Chemotherapy Versus Chemotherapy Alone in Colorectal Cancer Patients

Prophylactic Oophorectomy Followed by Chemotherapy Versus Chemotherapy Alone in Colorectal Patients With or Without Ovarian Metastasis

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 140 (actual)
• Sponsor: Gachon University Gil Medical Center · Academic / Other
• Sex: Female
• Age: 55 Years – 80 Years
• Healthy volunteers: Not accepted

Summary

This is a prospective phase III trial to define the role of oophorectomy in metastatic colorectal cancer patients with ovarian metastasis.

Detailed description

A recent study demonstrated that colorectal cancer with ovarian metastases were less responsive to chemotherapy compared to extraovarian metastases. The survival impact of oophorectomy has not been defined yet in this clinical setting. The incidence of microscopic ovarian metastasis has been reported to be approximately 10%. Therefore, the investigators propose a prospective study of oophorectomy followed by standard chemotherapy versus standard chemotherapy alone to determine whether oophorectomy increases survival.

Conditions

• Stage IV Colon Cancer

Interventions

Type	Name	Description
PROCEDURE	Oophrectomy	Both oophrectomy

Timeline

• Start date: 2008-08-01
• Primary completion: 2012-08-01
• Completion: 2013-08-01
• First posted: 2011-12-01
• Last updated: 2015-09-01

Locations

1 site across 1 country: South Korea