Oophorectomy Followed by Chemotherapy Versus Chemotherapy Alone in Colorectal Cancer Patients

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01483443
Recruitment Status : Completed
First Posted : December 1, 2011
Last Update Posted : September 1, 2015
Information provided by (Responsible Party):
Won-Suk Lee, 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.

Condition or disease Intervention/treatment Phase
Stage IV Colon Cancer Procedure: Oophrectomy Phase 3

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 Type : Interventional  (Clinical Trial)
Actual Enrollment : 140 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Prophylactic Oophorectomy Followed by Chemotherapy Versus Chemotherapy Alone in Colorectal Patients With or Without Ovarian Metastasis
Study Start Date : August 2008
Actual Primary Completion Date : August 2012
Actual Study Completion Date : August 2013

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
Experimental: Oophrectomy group
Patient undergone oophrectomy along with primary tumor
Procedure: Oophrectomy
Both oophrectomy
Other Name: No other intervention needed
No Intervention: without oophrectomy
Patient group without oophrectomy

Primary Outcome Measures :
  1. Overall survival [ Time Frame: 3 years ]

Secondary Outcome Measures :
  1. Disease free survival [ Time Frame: 3 years ]

Information from the National Library of Medicine

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Ages Eligible for Study:   55 Years to 80 Years   (Adult, Senior)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01483443

Korea, Republic of
Won-Suk Lee
Incheon, Korea, Republic of, 405-760
Sponsors and Collaborators
Gachon University Gil Medical Center
Principal Investigator: Won-Suk Lee, M.D. Gachon Univ. GIl Hospital

Responsible Party: Won-Suk Lee, Assistant Prof, Gachon University Gil Medical Center Identifier: NCT01483443     History of Changes
Other Study ID Numbers: GIRBA2263
First Posted: December 1, 2011    Key Record Dates
Last Update Posted: September 1, 2015
Last Verified: August 2015

Keywords provided by Won-Suk Lee, Gachon University Gil Medical Center: