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| Name | Class |
|---|---|
| Shanghai Zhongshan Hospital | OTHER |
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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).
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Total or Subtotal Colectomy | Experimental | 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 |
|
| Other Bowel Resection | Active Comparator | all patients who underwent partial intestinal resection as part of optimal cytoreductive surgery |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Total or Subtotal Colectomy | Procedure | Resect all or most parts of the colon: with total or subtotal colectomy as a part of optimal cytoreductive surgery(residual disease <=0.5cm) |
| 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Zhuozhen Sun, MD | Contact | +862164041990 | zhuozhen_sun@hotmail.com | |
| Yuting Luan, RN | Contact | +862164041990 | yutingluan@163.com |
| Name | Affiliation | Role |
|---|---|---|
| Rongyu Zang, MD,PhD | Shanghai Zhongshan Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Fudan University Shanghai Zhongshan Hospital | Recruiting | Shanghai | Shanghai Municipality | 200032 | China |
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| Label | URL |
|---|---|
| Shanghai Gynecologic Oncology Group | View source |
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| ID | Term |
|---|---|
| D000077216 | Carcinoma, Ovarian Epithelial |
| D005185 | Fallopian Tube Neoplasms |
| D010051 | Ovarian Neoplasms |
| ID | Term |
|---|---|
| D002277 | Carcinoma |
| D009375 | Neoplasms, Glandular and Epithelial |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
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| Other Bowel Resection | Procedure | 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) |
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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 |
| D004701 |
| Endocrine Gland Neoplasms |
| D009371 | Neoplasms by Site |
| D010049 | Ovarian Diseases |
| D000291 | Adnexal Diseases |
| D005831 | Genital Diseases, Female |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D005833 | Genital Neoplasms, Female |
| D014565 | Urogenital Neoplasms |
| D000091662 | Genital Diseases |
| D004700 | Endocrine System Diseases |
| D006058 | Gonadal Disorders |
| D005184 | Fallopian Tube Diseases |