Total/Subtotal Colectomy in Ovarian Cancer

Study Overview
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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.

Official Title
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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)

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

Intervention / Treatment
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* Procedure: Total or Subtotal Colectomy
* Procedure: Other Bowel Resection


Participation Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Total or Subtotal Colectomy<br>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<br>* Resect all or most parts of the colon: with total or subtotal colectomy as a part of optimal cytoreductive surgery(residual disease <=0.5cm)<br>* Other names: Subtotal Colectomy;|
| Active Comparator: Other Bowel Resection<br>all patients who underwent partial intestinal resection as part of optimal cytoreductive surgery | Procedure: Other Bowel Resection<br>* 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)<br>* Other names: Small bowel resection;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 
| Initiation of the first cycle chemotherapy | To compare the date between surgery and initiation of the first cycle chemo | up to 12 weeks | 
| Hospitalization expenses | the cost during hospital stay | up to 12 weeks | 
| Hospitalization days | length of hospital stay | up to 12 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Total or subtotal colectomy, Ovarian cancer, Complications, One-year disease-free survival, Stage IIIc, Stage IV