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Clinical study of first-line chemotherapy for ovarian cancer with paclitaxel and carboplatin albumin intravenous chemotherapy

Clinical study of first-line chemotherapy for ovarian cancer with paclitaxel and carboplatin albumin intravenous chemotherapy

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR-IOR-17010687
Enrollment
Unknown
Registered
2017-02-20
Start date
2017-03-01
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

ovarian cancer

Interventions

Paclitaxel intravenous combined with intraperitoneal chemotherapy:Paclitaxel intravenous combined with intraperitoneal chemotherapy
Albumin paclitaxel combined carboplatin chemotherapy:Albumin paclitaxel combined carboplatin chemotherapy

Sponsors

Renji Hospital, School of Medicine, Shanghai Jiao Tong University
Lead Sponsor

Eligibility

Sex/Gender
Female
Age
18 Years to No maximum

Inclusion criteria

Inclusion criteria: 1) Female aged 18 years old and more; 2) the first operation stage and receive complete cytoreductive surgery, including hysterectomy, double accessory, omentum, appendectomy and peritoneal tumor resection (residual tumor size: 1cm); histologically proved epithelial ovarian cancer; 3) no drug treatment before operation; 4) (US) ECOG score 0-2; 5) within 7 days after admission laboratory tests: blood leukocyte counts: >1500/mm3, >100000/mm3, platelet count liver function: 40ml/min; echocardiography EF normal; 7) signed informed consent and consent to the collection and use of information.

Exclusion criteria

Exclusion criteria: Any potential subject to any of the following criteria will not be able to participate in this study 1) non epithelial tumor or borderline tumor; 2) patients who underwent laparotomy for a two time or after chemotherapy; 3) Second patients with tumors or other tumors underwent surgical treatment, the treatment of this surgery and the treatment of recurrent ovarian cancer interference, or affect the prognosis of patients treated with this surgery; 4) platinum based chemotherapy has been used for treatment; 5) palliative care is planned only; 6) Combined disease is not suitable for surgery and / or chemotherapy; 7) radiotherapy, experimental treatment, hormone therapy, chemotherapy or biologic therapy; 8) there is a history of severe allergic reactions to any of the known drugs in clinical trials; 9) past medical history showed serious complications. Severe chronic obstructive pulmonary disease with hypoxemia; * uncontrolled hypertension, cerebrovascular accident / stroke, myocardial infarction, unstable angina, thrombosis and chronic congestive heart failure, or the need for drug treatment of severe arrhythmia; Severe hepatitis and liver disease; nephrotic syndrome, renal insufficiency; * history of active ulcer, abdominal wall fistula, perforation of the gastrointestinal tract, or intra-abdominal abscess, or simultaneous treatment / prevention of ulcer; Uncontrolled diabetes mellitus; * uncontrolled epilepsy requiring long-term anticonvulsant therapy.

Design outcomes

Primary

MeasureTime frame
CBC;liver function test;renal function test;routine urianlysis;tumor markers;

Countries

China

Contacts

Public ContactQIU LIHUA

Department of Gynecology and Obstetrics, Renji Hospital, School of Medicine, Shanghai Jiao Tong University

lilyqiulh@126.com+86 13801946776

Outcome results

None listed

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