Total/Subtotal Colectomy in Ovarian Cancer

July 23, 2016 updated by: Shanghai Gynecologic Oncology Group

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)

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).

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Anticipated)

80

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • China
    • Shanghai
      • Shanghai, Shanghai, China, 200032
        • Recruiting
        • Fudan University Shanghai Zhongshan Hospital
        • Contact:
        • Principal Investigator:
          • Rongyu Zang, MD,PhD
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Total or Subtotal Colectomy
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
Procedure: Total or Subtotal Colectomy
Resect all or most parts of the colon: with total or subtotal colectomy as a part of optimal cytoreductive surgery(residual disease <=0.5cm)
Other Names:
  • Radical surgery
  • Total Colectomy
  • Subtotal Colectomy
Active Comparator: Other Bowel Resection
all patients who underwent partial intestinal resection as part of optimal cytoreductive surgery
Procedure: Other Bowel Resection
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)
Other Names:
  • Partial Colectomy
  • Small bowel resection

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
up to 30 days after surgery

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The rate of 12- month- disease non-progression
Time Frame: up to 12 months
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)
up to 12 months
Initiation of the first cycle chemotherapy
Time Frame: up to 12 weeks
To compare the date between surgery and initiation of the first cycle chemo
up to 12 weeks
Hospitalization expenses
Time Frame: up to 12 weeks
the cost during hospital stay
up to 12 weeks
Hospitalization days
Time Frame: up to 12 weeks
length of hospital stay
up to 12 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Shanghai Gynecologic Oncology Group

Collaborators

Shanghai Zhongshan Hospital

Investigators

  • Principal Investigator: Rongyu Zang, MD,PhD, Shanghai Zhongshan Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2015

Primary Completion (Anticipated)

December 1, 2017

Study Completion (Anticipated)

December 1, 2018

Study Registration Dates

First Submitted

September 18, 2015

First Submitted That Met QC Criteria

October 30, 2015

First Posted (Estimate)

November 3, 2015

Study Record Updates

Last Update Posted (Estimate)

July 26, 2016

Last Update Submitted That Met QC Criteria

July 23, 2016

Last Verified

July 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • zsfud-obgyn-004

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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