Total/Subtotal Colectomy in Ovarian Cancer

Shanghai Gynecologic Oncology Group

Status and phase: Unknown; Phase 2

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

Treatments: Procedure: Total or Subtotal Colectomy; Procedure: Other Bowel Resection

Study type: Interventional

Funder types: Other

Identifiers

NCT02595021

zsfud-obgyn-004

Details and patient eligibility

About

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).

Full 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.

Enrollment: 80 estimated patients

Sex: Female

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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80 participants in 2 patient groups

Total or Subtotal Colectomy

Experimental group

Description:

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

Treatment:

Procedure: Total or Subtotal Colectomy

Other Bowel Resection

Active Comparator group

Description:

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

Treatment:

Procedure: Other Bowel Resection