Total/Subtotal Colectomy in Ovarian Cancer

NCT ID: NCT02595021

Last Updated: 2016-07-26

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE2

Total Enrollment

80 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-07-31

Study Completion Date

2018-12-31

Brief Summary

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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

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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.

Conditions

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Epithelial Ovarian Cancer Fallopian Tube Cancer Primary Peritoneal Carcinoma Secondary Malignant Neoplasm of Large Intestine

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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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

Group Type EXPERIMENTAL

Total or Subtotal Colectomy

Intervention Type PROCEDURE

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 Bowel Resection

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

Group Type ACTIVE_COMPARATOR

Other Bowel Resection

Intervention Type PROCEDURE

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)

Interventions

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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)

Intervention Type 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)

Intervention Type PROCEDURE

Other Intervention Names

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Radical surgery Total Colectomy Subtotal Colectomy Partial Colectomy Small bowel resection

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Shanghai Zhongshan Hospital

OTHER

Sponsor Role collaborator

Shanghai Gynecologic Oncology Group

OTHER_GOV

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Rongyu Zang, MD,PhD

Role: PRINCIPAL_INVESTIGATOR

Shanghai Zhongshan Hospital

Locations

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Fudan University Shanghai Zhongshan Hospital

Shanghai, Shanghai Municipality, China

Site Status RECRUITING

Countries

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China

Central Contacts

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Zhuozhen Sun, MD

Role: CONTACT

+862164041990

Yuting Luan, RN

Role: CONTACT

+862164041990

Facility Contacts

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Zhuozhen Sun, MD

Role: primary

+862164041990

Yuting Luan, RN

Role: backup

+862164041990

Related Links

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http://www.ShanghaiGOG.org

Shanghai Gynecologic Oncology Group

Other Identifiers

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zsfud-obgyn-004

Identifier Type: -

Identifier Source: org_study_id

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