Know Cancer

or
forgot password

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


Phase 3
55 Years
80 Years
Open (Enrolling)
Female
Stage IV Colon Cancer

Thank you

Trial Information

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


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.

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment

Outcome Measure:

Overall survival

Outcome Time Frame:

3 years

Safety Issue:

No

Principal Investigator

Won-Suk Lee, M.D.

Investigator Role:

Principal Investigator

Investigator Affiliation:

Gachon Univ. GIl Hospital

Authority:

Korea: Institutional Review Board

Study ID:

GIRBA2263

NCT ID:

NCT01483443

Start Date:

August 2008

Completion Date:

August 2012

Related Keywords:

  • Stage IV Colon Cancer
  • oophrectomy
  • survival
  • Colonic Neoplasms

Name

Location