NCT02595021
Unknown
Phase 2
A Phase II Study of Total or Subtotal Colectomy in Stage IIIC and Stage IV Epithelial Ovarian, Fallopian Tube, and Primary Peritoneal Cancer (EOC, FTC, PPC)
Shanghai Gynecologic Oncology Group1 site in 1 country80 target enrollmentStarted: July 2015Last updated:
Overview
- Phase
- Phase 2
- Sponsor
- Shanghai Gynecologic Oncology Group
- Enrollment
- 80
- Locations
- 1
- Primary Endpoint
- Postoperative complications
Overview
Brief Summary
The purpose of this study is to evaluate the safety and one year disease-free survival of total or subtotal colectomy and proctocolectomy in stage IIIc and stage IV epithelial ovarian, fallopian tube, and primary peritoneal cancer (EOC, FTC, PPC).
Detailed Description
This trial is to assess the perioperative complications, hospitalization expenses and days, and one year disease-free survival of patients who underwent total or subtotal colectomy as part of the surgical procedures for ovarian cancer, versus partial intestinal resection in the therapy for ovarian cancer.
Study Design
- Study Type
- Interventional
- Allocation
- Non Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to 75 Years (Adult, Older Adult)
- Sex
- Female
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Age ≥18 years and ≤ 75 years.
- •Epithelial ovarian cancer, fallopian tube cancer, primary peritoneal carcinoma with pathology confirmed International Federation of Gynecology and Obstetrics (FIGO) stage IIIc or IV
- •Extensive colonic metastasis, tumor involving the major part of bowel surface and/or mesentery
- •Optimal cytoreductive surgery, including hysterectomy, bilateral salpinges-oophorectomy, omentectomy, and resection of all metastatic lesions, with a residual disease no more than 0.5cm
- •Eastern Cooperative Oncology Group (ECOG) performance status 0-
- •American Society of Anesthesiologists (ASA) performance 1-
- •Follow-up available.
- •Written informed consent.
Exclusion Criteria
- •Low-malignant potential ovarian tumor.
- •Patient who underwent enterostomy in the surgery procedure.
- •Tumor involving small intestine alone.
- •More than 2 anastomoses.
- •Other condition that could interfere with provision of informed consent, compliance to study procedures, or follow-up.
- •Prior invasive malignancies within the last 5 years showing activity of disease.
Outcomes
Primary Outcomes
Postoperative complications
Time Frame: up to 30 days after surgery
Assessed by Common Terminology Criteria for Adverse Events version 4.0 up to 30 days after surgery
Secondary Outcomes
- The rate of 12- month- disease non-progression(up to 12 months)
- Initiation of the first cycle chemotherapy(up to 12 weeks)
- Hospitalization expenses(up to 12 weeks)
- Hospitalization days(up to 12 weeks)
Investigators
Study Sites (1)
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