Clinical Trial: Oophorectomy Followed by Chemotherapy Versus Chemotherapy Alone in Colorectal Cancer Patients
Study Status: Completed
Recruit Status: Completed
Study Type: Interventional
Official Title: Prophylactic Oophorectomy Followed by Chemotherapy Versus Chemotherapy Alone in Colorectal Patients With or Without Ovarian Metastasis
Brief Summary: This is a prospective phase III trial to define the role of oophorectomy in metastatic colorectal cancer patients with ovarian metastasis.
Detailed Summary: 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.
Sponsor: Gachon University Gil Medical Center
Current Primary Outcome: Overall survival [ Time Frame: 3 years ]
Original Primary Outcome: Same as current
Current Secondary Outcome: Disease free survival [ Time Frame: 3 years ]
Original Secondary Outcome: Same as current
Information By: Gachon University Gil Medical Center
Dates:
Date Received: November 29, 2011
Date Started: August 2008
Date Completion:
Last Updated: August 28, 2015
Last Verified: August 2015