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Total/Subtotal Colectomy in Ovarian Cancer

Primary Purpose

Epithelial Ovarian Cancer, Fallopian Tube Cancer, Primary Peritoneal Carcinoma

Status
Unknown status
Phase
Phase 2
Locations
China
Study Type
Interventional
Intervention
Total or Subtotal Colectomy
Other Bowel Resection
Sponsored by
Shanghai Gynecologic Oncology Group
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Epithelial Ovarian Cancer focused on measuring Total or subtotal colectomy, Ovarian cancer, Complications, One-year disease-free survival, Stage IIIc, Stage IV

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)FemaleDoes not accept healthy volunteers

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.

Sites / Locations

  • Fudan University Shanghai Zhongshan HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Total or Subtotal Colectomy

Other Bowel Resection

Arm 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

all patients who underwent partial intestinal resection as part of optimal cytoreductive surgery

Outcomes

Primary Outcome Measures

Postoperative complications
Assessed by Common Terminology Criteria for Adverse Events version 4.0 up to 30 days after surgery

Secondary Outcome Measures

The rate of 12- month- disease non-progression
Number of patients without progression in 12 months (From date of first chemotherapy until the date of first documented progression, assessed up to 12 months)
Initiation of the first cycle chemotherapy
To compare the date between surgery and initiation of the first cycle chemo
Hospitalization expenses
the cost during hospital stay
Hospitalization days
length of hospital stay

Full Information

First Posted
September 18, 2015
Last Updated
July 23, 2016
Sponsor
Shanghai Gynecologic Oncology Group
Collaborators
Shanghai Zhongshan Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT02595021
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)
Study Type
Interventional

2. Study Status

Record Verification Date
July 2016
Overall Recruitment Status
Unknown status
Study Start Date
July 2015 (undefined)
Primary Completion Date
December 2017 (Anticipated)
Study Completion Date
December 2018 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Shanghai Gynecologic Oncology Group
Collaborators
Shanghai Zhongshan Hospital

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Epithelial Ovarian Cancer, Fallopian Tube Cancer, Primary Peritoneal Carcinoma, Secondary Malignant Neoplasm of Large Intestine
Keywords
Total or subtotal colectomy, Ovarian cancer, Complications, One-year disease-free survival, Stage IIIc, Stage IV

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
80 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Total or Subtotal Colectomy
Arm Type
Experimental
Arm 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
Arm Title
Other Bowel Resection
Arm Type
Active Comparator
Arm Description
all patients who underwent partial intestinal resection as part of optimal cytoreductive surgery
Intervention Type
Procedure
Intervention Name(s)
Total or Subtotal Colectomy
Other Intervention Name(s)
Radical surgery, Total Colectomy, Subtotal Colectomy
Intervention Description
Resect all or most parts of the colon: with total or subtotal colectomy as a part of optimal cytoreductive surgery(residual disease <=0.5cm)
Intervention Type
Procedure
Intervention Name(s)
Other Bowel Resection
Other Intervention Name(s)
Partial Colectomy, Small bowel resection
Intervention Description
Resect part of the colon or small intestine: with other types of bowel resection as a part of optimal cytoreductive surgery(residual disease <=0.5cm)
Primary Outcome Measure Information:
Title
Postoperative complications
Description
Assessed by Common Terminology Criteria for Adverse Events version 4.0 up to 30 days after surgery
Time Frame
up to 30 days after surgery
Secondary Outcome Measure Information:
Title
The rate of 12- month- disease non-progression
Description
Number of patients without progression in 12 months (From date of first chemotherapy until the date of first documented progression, assessed up to 12 months)
Time Frame
up to 12 months
Title
Initiation of the first cycle chemotherapy
Description
To compare the date between surgery and initiation of the first cycle chemo
Time Frame
up to 12 weeks
Title
Hospitalization expenses
Description
the cost during hospital stay
Time Frame
up to 12 weeks
Title
Hospitalization days
Description
length of hospital stay
Time Frame
up to 12 weeks

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Zhuozhen Sun, MD
Phone
+862164041990
Email
zhuozhen_sun@hotmail.com
First Name & Middle Initial & Last Name or Official Title & Degree
Yuting Luan, RN
Phone
+862164041990
Email
yutingluan@163.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Rongyu Zang, MD,PhD
Organizational Affiliation
Shanghai Zhongshan Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Fudan University Shanghai Zhongshan Hospital
City
Shanghai
State/Province
Shanghai
ZIP/Postal Code
200032
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Zhuozhen Sun, MD
Phone
+862164041990
Email
zhuozhen_sun@hotmail.com
First Name & Middle Initial & Last Name & Degree
Yuting Luan, RN
Phone
+862164041990
Email
yutingluan@163.com
First Name & Middle Initial & Last Name & Degree
Rongyu Zang, MD,PhD

12. IPD Sharing Statement

Links:
URL
http://www.ShanghaiGOG.org
Description
Shanghai Gynecologic Oncology Group

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Total/Subtotal Colectomy in Ovarian Cancer

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