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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Oophrectomy group | Experimental | Patient undergone oophrectomy along with primary tumor |
|
| without oophrectomy | No Intervention | Patient group without oophrectomy |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Oophrectomy | Procedure | Both oophrectomy |
|
|
| Measure | Description | Time Frame |
|---|---|---|
| Overall survival | 3 years |
| Measure | Description | Time Frame |
|---|---|---|
| Disease free survival | 3 years |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Won-Suk Lee, M.D. | Gachon Univ. GIl Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Won-Suk Lee | Incheon | Incheon | 405-760 | South Korea |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 15047218 | Background | 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. |
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| ID | Term |
|---|---|
| D003110 | Colonic Neoplasms |
| ID | Term |
|---|---|
| D015179 | Colorectal Neoplasms |
| D007414 | Intestinal Neoplasms |
| D005770 | Gastrointestinal Neoplasms |
| D004067 | Digestive System Neoplasms |
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| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D004066 | Digestive System Diseases |
| D005767 | Gastrointestinal Diseases |
| D003108 | Colonic Diseases |
| D007410 | Intestinal Diseases |