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Gynecology Oncological clinical cooperation trial of Liposomal doxorubicin .

The study of comparison liposomal doxorubicin with topotecan for recurrent ovarian carcinoma after 6 months therapy of first-line platinum chemotherapy .

Status
Active, not recruiting
Phases
Phase 4
Study type
Observational
Source
ChiCTR
Registry ID
ChiCTR-ONC-13003650
Enrollment
Unknown
Registered
2013-09-25
Start date
2013-10-14
Completion date
Unknown
Last updated
2017-04-18

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

Conditions

ovarian cancer

Interventions

Case series:Liposomal doxorubicin

Sponsors

Shandong Tumor Hospital
Lead Sponsor

Eligibility

Sex/Gender
Female
Age
18 Years to 70 Years

Inclusion criteria

Inclusion criteria: 1. Aged 18 years and above; 2. Histopathological type was proved ovarian carcinoma; 3. Tester was given standard cytoreductivesurgery; 4. Tester suffered recrudescence of ovarian carcinoma in 6 months therapy of first-line platinum; 5. Karnofsky Performance Scale >=70%; 6. Good reserve of bone marrow: WBC>4.0*10^9/L, NEU>2.0*10^9/L, PLT>100*10^9/L; HGB>90g/L; 7. Good reserve of liver and kindey; 8. LVEF>=50%; 9. Women of childbearing age must be negative pregnancy test, besides the testers must take effective contraceptive measures for one year; 10. Written informed consent was provided by all patients prior to participation; 11. The PFS of before cancer > 5 years.

Exclusion criteria

Exclusion criteria: 1. For teseters received radiation therapy,must have recovered form hematologic toxicity before treatment; 2. Patients with heart diseases have identified NYHA class II score; 3. The patients are suitable for secondary cytoreductive surgery; 4. Acute or chronicinfection; 5. The patients have other malignancies within the past five years; 6. The patients are allergic or intolerant to Liposomal doxorubicin, paclitaxel or accessories; 7. Before gaven the first administration of study drugs ,patients have used any other test drugs; 8. Patients were excluded for previous chemotherapy with PLD, extracorporeal treatments; or chemotherapeutic drugs other than those proposed; 9. Expected survival <=3 months; 10. Lactating women or pregnancy; 11. Further exclusion criteria were patients not according with the participant's best interesting.

Design outcomes

Primary

MeasureTime frame
CA125;

Countries

China

Contacts

Public ContactXiugui sheng

Shandong Tumor Hospital

jnsxg@hotmail.com+86 13608921932

Outcome results

None listed

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