NCT01483443

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
140

participants targeted

Target at P25-P50 for phase_3

Timeline
Completed

Started Aug 2008

Longer than P75 for phase_3

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2008

Completed
3.3 years until next milestone

First Submitted

Initial submission to the registry

November 29, 2011

Completed
2 days until next milestone

First Posted

Study publicly available on registry

December 1, 2011

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2012

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2013

Completed
Last Updated

September 1, 2015

Status Verified

August 1, 2015

Enrollment Period

4 years

First QC Date

November 29, 2011

Last Update Submit

August 28, 2015

Conditions

Stage IV Colon Cancer

Keywords

oophrectomysurvival

Outcome Measures

Primary Outcomes (1)

  • Overall survival

    3 years

Secondary Outcomes (1)

  • Disease free survival

    3 years

Study Arms (2)

Oophrectomy group

EXPERIMENTAL

Patient undergone oophrectomy along with primary tumor

Procedure: Oophrectomy

without oophrectomy

NO INTERVENTION

Patient group without oophrectomy

Interventions

OophrectomyPROCEDURE

Both oophrectomy

Also known as: No other intervention needed
Oophrectomy group

Eligibility Criteria

Age55 Years - 80 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • age ≥ 18
  • histologically confirmed adenocarcinoma of colon
  • documented ovarian metastasis in CT or MRI or PET-CT
  • advanced (stage IV), metastatic, or recurrent
  • ECOG performance status of 0\~2
  • adequate marrow, hepatic, renal and cardiac functions
  • no prior surgical treatment to ovary
  • provision of a signed written informed consent

You may not qualify if:

  • patient who refuses oophorectomy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Won-Suk Lee

Incheon, Incheon, 405-760, South Korea

Location

Related Publications (1)

  • 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.

    PMID: 15047218BACKGROUND

MeSH Terms

Conditions

Colonic Neoplasms

Condition Hierarchy (Ancestors)

Colorectal NeoplasmsIntestinal NeoplasmsGastrointestinal NeoplasmsDigestive System NeoplasmsNeoplasms by SiteNeoplasmsDigestive System DiseasesGastrointestinal DiseasesColonic DiseasesIntestinal Diseases

Study Officials

  • Won-Suk Lee, M.D.

    Gachon Univ. GIl Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Prof

Study Record Dates

First Submitted

November 29, 2011

First Posted

December 1, 2011

Study Start

August 1, 2008

Primary Completion

August 1, 2012

Study Completion

August 1, 2013

Last Updated

September 1, 2015

Record last verified: 2015-08

Locations

KR(1)