Clinical trial · Interventional
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
NCT01483443CI-TRIAL-00018990completedPhase 3ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
This is a prospective phase III trial to define the role of oophorectomy in metastatic colorectal cancer patients with ovarian metastasis.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Stage IV Colon Cancer | Malignant Colon Neoplasm | CURATED_BROADER | 0.78 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Oophrectomy | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Oophrectomy group
- description
- Patient undergone oophrectomy along with primary tumor
- interventionNames
- Procedure: Oophrectomy
- type
- NO_INTERVENTION
- label
- without oophrectomy
- description
- Patient group without oophrectomy
Primary outcomes (1)
- measure
- Overall survival
- timeFrame
- 3 years
Secondary outcomes (1)
- measure
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 55 Years
- Maximum age
- 80 Years
Show eligibility criteria text
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.
References
Publications (1)
- BACKGROUNDMoore 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 15047218