Status:
COMPLETED
Oophorectomy Followed by Chemotherapy Versus Chemotherapy Alone in Colorectal Cancer Patients
Lead Sponsor:
Gachon University Gil Medical Center
Conditions:
Stage IV Colon Cancer
Eligibility:
FEMALE
55-80 years
Phase:
PHASE3
Brief 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 de...
Eligibility Criteria
Inclusion
- age ≥ 18
- histologically confirmed adenocarcinoma of colon
- documented ovarian metastasis in CT or MRI or PET-CT
- advanced (stage IV), metastatic, or recurrent
- ECOG performance status of 0\~2
- adequate marrow, hepatic, renal and cardiac functions
- no prior surgical treatment to ovary
- provision of a signed written informed consent
Exclusion
- patient who refuses oophorectomy
- medical condition in which surgery cannot be tolerated Any waiver of these inclusion and exclusion criteria must be approved by the investigator on a case-by case basis prior to enrolling the subject. This must be documented by the investigator. No subject will be allowed to enroll in this study more than once.
Key Trial Info
Start Date :
August 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 1 2013
Estimated Enrollment :
140 Patients enrolled
Trial Details
Trial ID
NCT01483443
Start Date
August 1 2008
End Date
August 1 2013
Last Update
September 1 2015
Active Locations (1)
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1
Won-Suk Lee
Incheon, Incheon, South Korea, 405-760