Oophorectomy Followed by Chemotherapy Versus Chemotherapy Alone in Colorectal Cancer Patients

Phase 3

Completed

• Conditions: Stage IV Colon Cancer
• Interventions: Procedure: Oophrectomy

• Registration Number: NCT01483443
• Lead Sponsor: Gachon University Gil Medical Center

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 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.

Study Timeline

• Study Start: 2008-08
• Study First Submitted: 2011-11-29
• Study First Submitted QC: 2011-11-30
• Study First Posted: 2011-12-01
• Primary Completion: 2012-08
• Study Completion: 2013-08
• Status Verified: 2015-08
• Last Update Submitted: 2015-08-28
• Last Update Posted: 2015-09-01

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 140

Inclusion Criteria

1. age ≥ 18
2. histologically confirmed adenocarcinoma of colon
3. documented ovarian metastasis in CT or MRI or PET-CT
4. advanced (stage IV), metastatic, or recurrent
5. ECOG performance status of 0~2
6. adequate marrow, hepatic, renal and cardiac functions
7. no prior surgical treatment to ovary
8. provision of a signed written informed consent

Exclusion Criteria

1. patient who refuses oophorectomy
2. 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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Oophrectomy group	Oophrectomy	Patient undergone oophrectomy along with primary tumor

Primary Outcome Measures

Name	Time	Method
Overall survival	3 years

Secondary Outcome Measures

Name	Time	Method
Disease free survival	3 years

Trial Locations

Locations (1)

Won-Suk Lee; 🇰🇷 Incheon, Korea, Republic of