A Study of Docetaxel and Lobaplatin Versus Docetaxel and Carboplatin Combination Regimen in Patients With Platinum-sensitive (>6 Months) Relapsed Ovarian Cancer

Recurrent Ovarian Cancer Clinical Trial

Official title:

A Study of Docetaxel and Lobaplatin vs. Docetaxel and Carboplatin Combination Regimen in Patients With Platinum-sensitive (>6 Months) Relapsed Ovarian Cancer

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT01851746
• Other study ID #: CHB2013
• Status: Active, not recruiting
• Phase: N/A
• First received: May 7, 2013
• Last updated: May 9, 2013
• Start date: March 2013
• Est. completion date: February 2015

Study information

• Verified date: May 2013
• Source: Wuhan University
• Contact: n/a
• Is FDA regulated: No
• Health authority: China: Ethics Committee
• Study type: Observational

Clinical Trial Summary

The purpose of this study is to evaluate the effectiveness and security of lobaplatin combined with docetaxel in treatment of the sensitive recurrent ovarian cancer.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 200
• Est. completion date: February 2015
• Est. primary completion date: February 2015
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 70 Years

Eligibility

Inclusion Criteria:

1. age between 18 and 70 years old

2. singed the information consent form

3. Expected survival time >3 months

4. Recurrence for at least 6 months after receiving initial platinum-based chemotherapy and without cytoreductive surgery indications.

Exclusion Criteria:

1. Recurrence within 6 months after receiving initial platinum-based chemotherapy

2. without radiographic evidence for tumor recurrence

3. receiving other chemotherapy, hormone therapy, immunotherapy, or radiation therapy

Study Design

Observational Model: Case Control, Time Perspective: Prospective

Related Conditions & MeSH terms

• Ovarian Neoplasms
• Recurrent Ovarian Cancer

Locations

Country	Name	City	State
China	Zhongnan Hospital of Wuhan University	Wuhan	Hubei

Sponsors (1)

Lead Sponsor	Collaborator
Wuhan University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Evidence of the effectiveness and security of lobaplatin combined with docetaxel in treatment of the sensitive recurrent ovarian cancer.	Blood routine, urine routine, hepatic and kidney function, electrolyte, ECG, CT,MRI	from pre-chemotherapy to 4-6 weeks post-chemotherapy	Yes