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A multicenter prospective randomized controlled study of tumor cytoreductive surgery combined with hyperthermic intraperitoneal chemotherapy in the treatment of new diagnosed ovarian cancer

A multicenter prospective randomized controlled study of tumor cytoreductive surgery combined with hyperthermic intraperitoneal chemotherapy in the treatment of new diagnosed ovarian cancer

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2000035912
Enrollment
Unknown
Registered
2020-08-20
Start date
2020-10-01
Completion date
Unknown
Last updated
2020-08-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Ovarian cancer

Interventions

Control group:Cytoreductive surgery + systemic chemotherapy
Trial group:Cytoreductive surgery + intraoperative HIPEC + systemic chemotherapy

Sponsors

Shanghai General Hospital
Lead Sponsor

Eligibility

Sex/Gender
Female

Inclusion criteria

Inclusion criteria: 1. Aged >= 18 years old; 2. Serous ovarian cancer, mucinous ovarian cancer, endometrioid ovarian cancer, fallopian tube cancer or primary peritoneal cancer; 3. Patients with newly diagnosed FIGO stage III (including neoadjuvant chemotherapy); 4. Patients with complete satisfactory reduction or residual lesions less than 1 cm; 5. Patients without other abdominal organ diseases and visceral metastasis; 6. Patients with ECoG score of 0 or 1; 7. Patients with normal blood routine, coagulation function and heart, liver and kidney function.

Exclusion criteria

Exclusion criteria: 1. Patients with evidence of pleural disease or lung metastasis; 2. Patients with peritoneal or mesenteric swelling or intestinal obstruction; 3. Patients with breast cancer or other abdominal and pelvic malignancies within 5 years before enrollment; 4. Patients with high risk factors of poor anastomotic healing, including anastomotic tissue ischemia and edema, obvious tension, severe hypoproteinemia, etc..

Design outcomes

Primary

MeasureTime frame
Progression-free survival;

Secondary

MeasureTime frame
2-year overall survival;

Countries

China

Contacts

Public ContactXi Xiaowei

Shanghai First People's Hospital

xixiaowei1966@126.com+86 13661632388

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026