Oophorectomy Followed by Chemotherapy Versus Chemotherapy Alone in Colorectal Cancer Patients

This study has been completed.
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: August 28, 2015
Last verified: August 2015

November 29, 2011
August 28, 2015
August 2008
August 2012   (final data collection date for primary outcome measure)
Overall survival [ Time Frame: 3 years ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01483443 on ClinicalTrials.gov Archive Site
Disease free survival [ Time Frame: 3 years ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
Oophorectomy Followed by Chemotherapy Versus Chemotherapy Alone in Colorectal Cancer Patients
Prophylactic Oophorectomy Followed by Chemotherapy Versus Chemotherapy Alone in Colorectal Patients With or Without Ovarian Metastasis
This is a prospective phase III trial to define the role of oophorectomy in metastatic colorectal cancer patients with ovarian metastasis.
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.
Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
Stage IV Colon Cancer
Procedure: Oophrectomy
Both oophrectomy
Other Name: No other intervention needed
  • Experimental: Oophrectomy group
    Patient undergone oophrectomy along with primary tumor
    Intervention: Procedure: Oophrectomy
  • No Intervention: without oophrectomy
    Patient group without oophrectomy
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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
140
August 2013
August 2012   (final data collection date for primary outcome measure)

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.
Female
55 Years to 80 Years   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
Korea, Republic of
 
NCT01483443
GIRBA2263
Yes
Not Provided
Not Provided
Won-Suk Lee, Gachon University Gil Medical Center
Gachon University Gil Medical Center
Not Provided
Principal Investigator: Won-Suk Lee, M.D. Gachon Univ. GIl Hospital
Gachon University Gil Medical Center
August 2015

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP