Oophorectomy Followed by Chemotherapy Versus Chemotherapy Alone in Colorectal Cancer Patients

Stage IV Colon Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01483443
• Other study ID #: GIRBA2263
• Status: Completed
• Phase: Phase 3
• First received: November 29, 2011
• Last updated: August 28, 2015
• Start date: August 2008
• Est. completion date: August 2013

Study information

• Verified date: August 2015
• Source: Gachon University Gil Medical Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: Korea: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 140
• Est. completion date: August 2013
• Est. primary completion date: August 2012
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 55 Years to 80 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Stage IV Colon Cancer

Intervention

Procedure:
• Oophrectomy
Both oophrectomy

Locations

Country	Name	City	State
Korea, Republic of	Won-Suk Lee	Incheon

Sponsors (1)

Lead Sponsor	Collaborator
Gachon University Gil Medical Center

Country where clinical trial is conducted

Korea, Republic of, 

References & Publications (1)

Moore RG, Chung M, Granai CO, Gajewski W, Steinhoff MM. Incidence of metastasis to the ovaries from nongenital tract primary tumors. Gynecol Oncol. 2004 Apr;93(1):87-91. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Overall survival		3 years	No
Secondary	Disease free survival		3 years	No