NCT02595021

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).

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
80

participants targeted

Target at P50-P75 for phase_2

Timeline
Completed

Started Jul 2015

Typical duration for phase_2

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2015

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

September 18, 2015

Completed
2 months until next milestone

First Posted

Study publicly available on registry

November 3, 2015

Completed
2.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2017

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2018

Completed
Last Updated

July 26, 2016

Status Verified

July 1, 2016

Enrollment Period

2.4 years

First QC Date

September 18, 2015

Last Update Submit

July 23, 2016

Conditions

Epithelial Ovarian CancerFallopian Tube CancerPrimary Peritoneal CarcinomaSecondary Malignant Neoplasm of Large Intestine

Keywords

Total or subtotal colectomyOvarian cancerComplicationsOne-year disease-free survivalStage IIIcStage IV

Outcome Measures

Primary Outcomes (1)

  • Postoperative complications

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

    up to 30 days after surgery

Secondary Outcomes (4)

  • 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

Study Arms (2)

Total or Subtotal Colectomy

EXPERIMENTAL

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

Other Bowel Resection

ACTIVE COMPARATOR

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

Procedure: Other Bowel Resection

Interventions

Total or Subtotal ColectomyPROCEDURE

Resect all or most parts of the colon: with total or subtotal colectomy as a part of optimal cytoreductive surgery(residual disease \<=0.5cm)

Also known as: Radical surgery, Total Colectomy, Subtotal Colectomy
Total or Subtotal Colectomy
Other Bowel ResectionPROCEDURE

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)

Also known as: Partial Colectomy, Small bowel resection
Other Bowel Resection

Eligibility Criteria

Age18 Years - 75 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Fudan University Shanghai Zhongshan Hospital

Shanghai, Shanghai Municipality, 200032, China

RECRUITING

Related Links

MeSH Terms

Conditions

Carcinoma, Ovarian EpithelialFallopian Tube NeoplasmsOvarian Neoplasms

Condition Hierarchy (Ancestors)

CarcinomaNeoplasms, Glandular and EpithelialNeoplasms by Histologic TypeNeoplasmsEndocrine Gland NeoplasmsNeoplasms by SiteOvarian DiseasesAdnexal DiseasesGenital Diseases, FemaleFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesGenital Neoplasms, FemaleUrogenital NeoplasmsGenital DiseasesEndocrine System DiseasesGonadal DisordersFallopian Tube Diseases

Study Officials

  • Rongyu Zang, MD,PhD

    Shanghai Zhongshan Hospital

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Zhuozhen Sun, MD

CONTACT

+862164041990zhuozhen_sun@hotmail.com

Yuting Luan, RN

CONTACT

+862164041990yutingluan@163.com

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER GOV
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 18, 2015

First Posted

November 3, 2015

Study Start

July 1, 2015

Primary Completion

December 1, 2017

Study Completion

December 1, 2018

Last Updated

July 26, 2016

Record last verified: 2016-07

Locations

CN(1)