Clinical trial NCT02595021: Total/Subtotal Colectomy in Ovarian Cancer
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)
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
Conditions: Epithelial Ovarian Cancer
Fallopian Tube Cancer
Primary Peritoneal Carcinoma
Secondary Malignant Neoplasm of Large Intestine
Keywords: Total or subtotal colectomy
Ovarian cancer
Complications
One-year disease-free survival
Stage IIIc
Stage IV
Lead sponsor: Shanghai Gynecologic Oncology Group
Sponsor class: OTHER_GOV
Collaborators: name: Shanghai Zhongshan Hospital
First posted: 2015-11-03
Enrollment: 80
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Postoperative complications
timeFrame: up to 30 days after surgery
Secondary outcomes:
measure: The rate of 12- month- disease non-progression
timeFrame: up to 12 months
measure: Initiation of the first cycle chemotherapy
timeFrame: up to 12 weeks
measure: Hospitalization expenses
timeFrame: up to 12 weeks
measure: Hospitalization days
timeFrame: up to 12 weeks
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Fudan University Shanghai Zhongshan Hospital
state: Shanghai
Study officials:
affiliation: Shanghai Zhongshan Hospital
name: Rongyu Zang, MD,PhD
role: PRINCIPAL_INVESTIGATOR
References: