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Oophorectomy Followed by Chemotherapy Versus Chemotherapy Alone in Colorectal Cancer Patients

Primary Purpose

Stage IV Colon Cancer

Status

Completed

Phase

Phase 3

Locations

Korea, Republic of

Study Type

Interventional

Intervention

Oophrectomy

About this trial

This is an interventional treatment trial for Stage IV Colon Cancer focused on measuring oophrectomy, survival

Eligibility Criteria

55 Years - 80 Years (Adult, Older Adult)FemaleDoes not accept 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.

Sites / Locations

Won-Suk Lee

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Oophrectomy group

without oophrectomy

Arm Description

Patient undergone oophrectomy along with primary tumor

Patient group without oophrectomy

Outcomes

Primary Outcome Measures

Overall survival

Secondary Outcome Measures

Disease free survival

Full Information

NCT ID

NCT01483443

First Posted

November 29, 2011

Last Updated

August 28, 2015

Sponsor

Gachon University Gil Medical Center

1. Study Identification

Unique Protocol Identification Number

NCT01483443

Brief Title

Oophorectomy Followed by Chemotherapy Versus Chemotherapy Alone in Colorectal Cancer Patients

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

August 2015

Overall Recruitment Status

Completed

Study Start Date

August 2008 (undefined)

Primary Completion Date

August 2012 (Actual)

Study Completion Date

August 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Gachon University Gil Medical Center

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Stage IV Colon Cancer

Keywords

oophrectomy, survival

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 3

Interventional Study Model

Parallel Assignment

Masking

Outcomes Assessor

Allocation

Randomized

Enrollment

140 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Oophrectomy group

Arm Type

Experimental

Arm Description

Patient undergone oophrectomy along with primary tumor

Arm Title

without oophrectomy

Arm Type

No Intervention

Arm Description

Patient group without oophrectomy

Intervention Type

Procedure

Intervention Name(s)

Oophrectomy

Other Intervention Name(s)

No other intervention needed

Intervention Description

Both oophrectomy

Primary Outcome Measure Information:

Title

Overall survival

Time Frame

3 years

Secondary Outcome Measure Information:

Title

Disease free survival

Time Frame

3 years

10. Eligibility

Sex

Female

Minimum Age & Unit of Time

55 Years

Maximum Age & Unit of Time

80 Years

Accepts Healthy Volunteers

Eligibility Criteria

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.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Won-Suk Lee, M.D.

Organizational Affiliation

Gachon Univ. GIl Hospital

Official's Role

Principal Investigator

Facility Information:

Facility Name

Won-Suk Lee

City

Incheon

ZIP/Postal Code

405-760

Country

Korea, Republic of

12. IPD Sharing Statement

Citations:

PubMed Identifier

15047218

Citation

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. doi: 10.1016/j.ygyno.2003.12.039.

Results Reference

background

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Oophorectomy Followed by Chemotherapy Versus Chemotherapy Alone in Colorectal Cancer Patients

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