Epithelial Ovarian Cancer, Fallopian Tube Cancer, Primary Peritoneal Carcinoma, Secondary Malignant Neoplasm of Large Intestine
Conditions
Keywords
Total or subtotal colectomy, Ovarian cancer, Complications, One-year disease-free survival, Stage IIIc, Stage IV
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.
Interventions
PROCEDURETotal 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)
PROCEDUREOther 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)
Sponsors
Shanghai Zhongshan Hospital
Shanghai Gynecologic Oncology Group
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 75 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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 |
Countries
China
Contacts
Primary ContactZhuozhen Sun, MD
Backup ContactYuting Luan, RN
Outcome results
None listed