Oophorectomy Followed by Chemotherapy Versus Chemotherapy Alone in Colorectal Cancer Patients

Gachon University Gil Medical Center

Status and phase

Completed

Phase 3

Conditions

Stage IV Colon Cancer

Treatments

Procedure: Oophrectomy

Study type

Interventional

Funder types

Other

Identifiers

NCT01483443

GIRBA2263

Details and patient eligibility

About

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

Full 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.

Enrollment

140 patients

Sex

Female

Ages

55 to 80 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

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 criteria

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.