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Completed

NCT Number: NCT01483443

Oophorectomy Followed by Chemotherapy Versus Chemotherapy Alone in Colorectal Cancer Patients

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

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Key information

Age range

55 year–80 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 3

Primary location

Won-Suk Lee

Incheon, 405-760, South Korea

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

  • patient who refuses oophorectomy
  • 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.

Treatment and study plan

Oophrectomy

Procedure

Both oophrectomy

Other names: No other intervention needed

Primary outcomes

  1. Overall survival

    Time frame: 3 years

Secondary outcomes

  1. Disease free survival

    Time frame: 3 years

Sponsors and collaborators

Lead sponsor

Gachon University Gil Medical Center

Other

Registry information

Official study title

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

Important dates

Study start
2008
Primary completion
2012
Study completion
2013
First posted
Dec 1, 2011
Registry last updated
Sep 1, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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