Oophorectomy Followed by Chemotherapy Versus Chemotherapy Alone in Colorectal Cancer Patients

NCT ID: NCT01483443

Last Updated: 2015-09-01

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

140 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-08-31

Study Completion Date

2013-08-31

Brief Summary

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

Detailed Description

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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.

Conditions

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Stage IV Colon Cancer

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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Oophrectomy group

Patient undergone oophrectomy along with primary tumor

Group Type EXPERIMENTAL

Oophrectomy

Intervention Type PROCEDURE

Both oophrectomy

without oophrectomy

Patient group without oophrectomy

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Oophrectomy

Both oophrectomy

Intervention Type PROCEDURE

Other Intervention Names

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No other intervention needed

Eligibility Criteria

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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
Minimum Eligible Age

55 Years

Maximum Eligible Age

80 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Gachon University Gil Medical Center

OTHER

Sponsor Role lead

Responsible Party

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Won-Suk Lee

Assistant Prof

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Won-Suk Lee, M.D.

Role: PRINCIPAL_INVESTIGATOR

Gachon Univ. GIl Hospital

Locations

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Won-Suk Lee

Incheon, Incheon, South Korea

Site Status

Countries

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South Korea

References

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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.

Reference Type BACKGROUND
PMID: 15047218 (View on PubMed)

Other Identifiers

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GIRBA2263

Identifier Type: -

Identifier Source: org_study_id

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