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Aoxianda (Nedaplati) combined with Paclitaxel for treatment of epithelial ovarian cancer: a randomized, multicenter, parallel-controlled clinical trial

Aoxianda (Nedaplati) combined with Paclitaxel for treatment of epithelial ovarian cancer: a randomized, multicenter, parallel-controlled clinical trial

Status
Active, not recruiting
Phases
Phase 4
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR-TRC-11001333
Enrollment
Unknown
Registered
2011-04-25
Start date
2010-08-01
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

epithelial ovarian cancer

Interventions

Control:Day 1: Paclitaxel 135 mg/m2
Day 2: Carboplati AUC=5
repeat every 3 wks for 6 cycles.
Treatment:Day 1: Paclitaxel 135 mg/m2
Day 2: Aoxianda 80mg/m2

Sponsors

1st people hospital of Shanghai
Lead Sponsor

Eligibility

Sex/Gender
Female
Age
18 Years to 70 Years

Inclusion criteria

Inclusion criteria: 1. epithelial ovarian cancer (II stage at least) confirmed by pathology or cytology; 2. Patients who need chemotherapy after successful cytoreductive surgery (residual tumor diameter60; 4. expectant survival >6 month; 5. Aged 18-70 yrs; 6. hemopoietic function of bone marrow is normal: WBC>=4*10^9/L, N>=2.0*10^9, Hb>90g/L, PLT >=100*10^9/L; 7. AST and/or ALT is lower than 2.5 times of UL, serum total bilirubin <1.5 times of UL; 9. Normal heart, lung, liver and kidney function10 No intracranial and bone metastases11 Patients who have good adherence.

Exclusion criteria

Exclusion criteria: 1. Patients who participated in other trial or used other medicine in last 4 wks. 2. Patients with severe uncontrolled disease or acute infection. 3. Patients with another primary malignant neoplasm. 4. Pregnant or lactating women 5. Patients with peripheral neuropathy (>=2 stage)

Design outcomes

Primary

MeasureTime frame
Overall survival;CA125;Quality of life;Progress-free surviva;

Countries

China

Contacts

Public ContactYouji Feng
fengyj4806@sohu.com+86 21 63240090

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 24, 2026