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Oophorectomy Followed by Chemotherapy Versus Chemotherapy Alone in Colorectal Cancer Patients

This study is currently recruiting participants.
Verified January 2012 by Gachon University Gil Medical Center
Sponsor:
Information provided by (Responsible Party):
Won-Suk Lee, Gachon University Gil Medical Center
ClinicalTrials.gov Identifier:
NCT01483443
First received: November 29, 2011
Last updated: January 1, 2012
Last verified: January 2012
History of Changes
  Purpose

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


Condition Intervention Phase
Stage IV Colon Cancer
 Procedure: Oophrectomy
 Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Prophylactic Oophorectomy Followed by Chemotherapy Versus Chemotherapy Alone in Colorectal Patients With or Without Ovarian Metastasis

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Gachon University Gil Medical Center:

Primary Outcome Measures:
  • Overall survival [ Time Frame: 3 years ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Disease free survival [ Time Frame: 3 years ] [ Designated as safety issue: No ]

Estimated Enrollment: 140
Study Start Date: August 2008
Estimated Study Completion Date: August 2012
Estimated Primary Completion Date: August 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.

  Eligibility

Ages Eligible for Study:   55 Years to 80 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01483443

Contacts
Contact: Won-Suk Lee, M.D. 82-32-460-3289 lws@gilhospital.com

Locations
Korea, Republic of
Won-Suk Lee Recruiting
Incheon, Korea, Republic of, 405-760
Contact: Sooyong Ko         irb@gilhospital.com    
Principal Investigator: Won-Suk Lee, M.D            
Sponsors and Collaborators
Gachon University Gil Medical Center
Investigators
Principal Investigator: Won-Suk Lee, M.D. Gachon Univ. GIl Hospital
  More Information

Publications:

Responsible Party: Won-Suk Lee, Assistant Prof, Gachon University Gil Medical Center
ClinicalTrials.gov Identifier: NCT01483443     History of Changes
Other Study ID Numbers: GIRBA2263
Study First Received: November 29, 2011
Last Updated: January 1, 2012
Health Authority: Korea: Institutional Review Board

Keywords provided by Gachon University Gil Medical Center:
oophrectomy
survival

Additional relevant MeSH terms:
Colonic Neoplasms
Colorectal Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
 Neoplasms
Digestive System Diseases
Gastrointestinal Diseases
Colonic Diseases
Intestinal Diseases

ClinicalTrials.gov processed this record on May 21, 2013