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A multi-center, prospective, randomized, controlled trial for laparoscopic versus abdominal primary cytoreduction in the treatment of stage IIIB and IIIC ovarian epithelial cancer

A multi-center, prospective, randomized, controlled trial for laparoscopic versus abdominal primary cytoreduction in the treatment of stage IIIB and IIIC ovarian epithelial cancer

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR1800018717
Enrollment
Unknown
Registered
2018-10-05
Start date
2018-10-10
Completion date
Unknown
Last updated
2018-10-10

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

Conditions

FIGO stage IIIB and IIIC ovarian epithelial tumor

Interventions

Group 2:abdominal primary cytoreduction

Sponsors

Obstetrics and Gynecology of the First Affiliated Hospital of Army Medical University, PLA
Lead Sponsor

Eligibility

Sex/Gender
Female
Age
18 Years to 70 Years

Inclusion criteria

Inclusion criteria: 1. definitely diagnosing the ovarian epithelial cancer before or during surgery by biopsy; 2. female aged between 18-70 years old; 3. tumors confined to abdominopelvic cavity,preoperatively evaluated or laparoscopic explore as the FIGO IIIB and IIIC; 4. the largest tumor diameter =15cm; 5. without any medical and surgical complications and laparoscopic surgey'contraindications; 6. patients volunteer to join in the study and follow up; 7. Fagotti score=8; 8. patients who received six to eight cycles of platinum-based chemotherapy and finished twice Intraperitoneal chemotherapy.

Exclusion criteria

Exclusion criteria: 1. once receiving abdominal surgery for maglignant tumor or abdominal surgery more than once; 2. large abdominal mass or ascites causing difficult breathing or CO2 pneumoperitoneum; other unexpected occasions elevated by the operator so as to abdominal surgery; 3. complicated with DIE; 4. pregnant women or pregnancy tests(serum or urine) showing positive seven days ago before enrolling; 5. patiens and relations involuntary to the study or unaffordable to study hazards; 6. conforming the laparoscopybased exclusion criteria; 1) massive omental cake; 2) obliterated Morisons pouch; 3) involvement of lesser omentum; 4) involvement of the retrohepatic diaphragm, multiple(>3) and/or single (>2cm) diaphragmatic carcinomatosis; 5) larger than 2cm disease on the surface or/and on the right lobe of liver larger than 2cm or/and involvement of liver parenchyma or/and; 6) unresectable upper abdominal metastases such as omental disease involving the spleen; 7) the necessity of more than two bowel resections; 8) bulky aortic nodal; 9) obliterated spleno-colic ligament.

Design outcomes

Primary

MeasureTime frame
overall survial;disease free survival;

Secondary

MeasureTime frame
residual tumor;

Countries

China

Contacts

Public ContactZhiqing Ling

Obstetrics and Gynecology of the First Affiliated Hospital of Army Medical University, PLA

liangzq@163.com+86 023 65318301

Outcome results

None listed

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