Stage IV Colon Cancer
Conditions
Keywords
oophrectomy, survival
Brief summary
This is a prospective phase III trial to define the role of oophorectomy in metastatic colorectal cancer patients with ovarian metastasis.
Detailed description
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.
Interventions
PROCEDUREOophrectomy
Both oophrectomy
Sponsors
Gachon University Gil Medical Center
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
FEMALE
Age
55 Years to 80 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Overall survival | 3 years |
Secondary
| Measure | Time frame |
|---|---|
| Disease free survival | 3 years |
Countries
South Korea
Outcome results
None listed