Total/Subtotal Colectomy in Ovarian Cancer

Fallopian Tube Cancer Clinical Trial

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)

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02595021
• Other study ID #: zsfud-obgyn-004
• Status: Recruiting
• Phase: Phase 2
• First received: September 18, 2015
• Last updated: July 23, 2016
• Start date: July 2015
• Est. completion date: December 2018

Study information

• Verified date: July 2016
• Source: Shanghai Gynecologic Oncology Group
• Contact: Zhuozhen Sun, MD
• Phone: +862164041990
• Email: zhuozhen_sun[@]hotmail.com
• Is FDA regulated: No
• Health authority: China: Ethics Committee
• Study type: Interventional

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 80
• Est. completion date: December 2018
• Est. primary completion date: December 2017
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 75 Years

Eligibility

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

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Colonic Neoplasms
• Colorectal Neoplasms
• Epithelial Ovarian Cancer
• Fallopian Tube Cancer
• Fallopian Tube Neoplasms
• Neoplasms
• Neoplasms, Glandular and Epithelial
• Neoplasms, Second Primary
• Ovarian Neoplasms
• Primary Peritoneal Carcinoma
• Secondary Malignant Neoplasm of Large Intestine

Intervention

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 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)

Locations

Country	Name	City	State
China	Fudan University Shanghai Zhongshan Hospital	Shanghai	Shanghai

Sponsors (2)

Lead Sponsor	Collaborator
Shanghai Gynecologic Oncology Group	Shanghai Zhongshan Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Yes
Secondary	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)	up to 12 months	No
Secondary	Initiation of the first cycle chemotherapy	To compare the date between surgery and initiation of the first cycle chemo	up to 12 weeks	Yes
Secondary	Hospitalization expenses	the cost during hospital stay	up to 12 weeks	No
Secondary	Hospitalization days	length of hospital stay	up to 12 weeks	No

External Links

•   Shanghai Gynecologic Oncology Group