Brief Title
Total/Subtotal Colectomy in Ovarian Cancer
Official Title
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)
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 Phase
Phase 2
Study Type
Interventional
Primary Outcome
Postoperative complications
Secondary Outcome
The rate of 12- month- disease non-progression
Condition
Epithelial Ovarian Cancer
Intervention
Total or Subtotal Colectomy
Study Arms / Comparison Groups
Total or Subtotal Colectomy
Description: all patients who underwent total colectomy(removal of the large intestine from ileum to the rectum. After it is removed, the end of the small intestine is sewn to the rectum) or subtotal colectomy(removal of transverse colon, descending colon, sigmoid colon to the rectum. After it is removed, the end of the ascending colon is sewn to the rectum)as part of optimal cytoreductive surgery
Publications
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
Recruitment Information
Recruitment Status
Procedure
Estimated Enrollment
80
Start Date
July 2015
Completion Date
December 2018
Primary Completion Date
December 2017
Eligibility Criteria
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 0-2.
- American Society of Anesthesiologists (ASA) performance 1-2.
- 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.
Gender
Female
Ages
18 Years - 75 Years
Accepts Healthy Volunteers
No
Contacts
Rongyu Zang, MD,PhD, +862164041990, [email protected]
Location Countries
China
Location Countries
China
Administrative Informations
NCT ID
NCT02595021
Organization ID
zsfud-obgyn-004
Responsible Party
Sponsor
Study Sponsor
Shanghai Gynecologic Oncology Group
Collaborators
Shanghai Zhongshan Hospital
Study Sponsor
Rongyu Zang, MD,PhD, Principal Investigator, Shanghai Zhongshan Hospital
Verification Date
July 2016