Total/Subtotal Colectomy in Ovarian Cancer

Phase 2

• Conditions: Primary Peritoneal Carcinoma; Epithelial Ovarian Cancer; Fallopian Tube Cancer; Secondary Malignant Neoplasm of Large Intestine
• Interventions: Procedure: Other Bowel Resection; Procedure: Total or Subtotal Colectomy

• Registration Number: NCT02595021
• Lead Sponsor: Shanghai Gynecologic Oncology Group

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 Timeline

• Study Start: 2015-07
• Study First Submitted: 2015-09-18
• Study First Submitted QC: 2015-10-30
• Study First Posted: 2015-11-03
• Status Verified: 2016-07
• Last Update Submitted: 2016-07-23
• Last Update Posted: 2016-07-26
• Primary Completion: 2017-12
• Study Completion: 2018-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Female
• Target Recruitment: 80

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Other Bowel Resection	Other Bowel Resection	all patients who underwent partial intestinal resection as part of optimal cytoreductive surgery
Total or Subtotal Colectomy	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

Primary Outcome Measures

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

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Fudan University Shanghai Zhongshan Hospital; 🇨🇳 Shanghai, Shanghai, China