Carboplatin and Paclitaxel (Taxol) versus Carboplatin and Paclitaxel (Taxol) followed by Carboplatin for frontline chemotherapy in advanced ovarian carcinoma. A Hellenic Cooperative Oncology Group Study
- Conditions
- Advanced Ovarian CancerCancer - Ovarian and primary peritoneal
- Registration Number
- ACTRN12610000309088
- Lead Sponsor
- Hellenic Cooperative Oncology Group
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Female
- Target Recruitment
- 412
Histologically confirmed epithelial carcinoma of ovarian origin, Federation of International Gynaecological Oncologists (FIGO) stage IIc, III or IV at laparotomy, regardless of measurable or non-measurable disease.
Patients with non measurable or evaluable disease with either elevated or normal cancer antigen 125 (CA-125) levels according to the baseline assessment are eligible for the study but they are not evaluable for clinical response to chemotherapy.
No previous chemotherapy or immunotherapy for this disease.
There is no maximum age restriction, provided that patients are biologically fit.
Laboratory values within the 2 weeks preceeding the start of the study treatment:
*White Blood Cell count (WBC) >3.5x10 ^9/l
*neutrophil count >1.5x10^9/liter (l)
*platelet count >100x10^9/l
*serum billirubin >1.5 miligrams (mg)/deciliter (dL)
*creatinine cleareance>50 milliliters (ml)/minute (min)
Performance status World Health Organization(WHO) <=2.
No symptoms or signs of cardiac insufficiency or acute coronary disease.
Informed consent in accordance with the dispositions of the Helsinki, Tokyo and Venice declarations . The informed consent is to be registered in the patients’ records.
Patients must be geographically accessible for treatment and follow-up.
Patients must be enrolled within six weeks after the definitive laparotomy.
Prior chemotherapy or radiation treatment
Other malignant tumor or tumor history, except for non melanoma skin cancer or radicaly excised in situ carcinoma of the uterine cervix
Performance status (WHO)>2
Absolute Neutrophil Count < 1.5x10^9/l or platelet count < 100x10^9/l.
History of atrial or ventricular arrhythmias and/or history of congestive heart failure, even if medically controlled. History of clinically and electrocardiographically documented myocardial infarction within the last 6 months.
Active infection or other serious underlying medical conditions which would impair the ability of the patient to receive protocol treatment, including prior allergic reactions to drugs containing chemophor, such as teniposide or cyclosporin.
Administration of other therapeutic drugs or hormonal therapy during the study period.
Patients with complete bowel obstruction and/or with brain metastases.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Overall Survival (OS)[3 years following randomisation. This outcome is assessed using clinical data records]
- Secondary Outcome Measures
Name Time Method Disease-Free Survival (DFS)[18 months from study initiation. This outcome is assessed by physical examination, laboratory evaluation of hematology and biochemistry, computed tomography (CT), bone scan (if indicated) etc.];To compare toxicity (especially neuroroxicity) between the two treatment arms[Toxicity is assessed after each cycle by laboratory evaluation of hematology and biochemistry, physical examination etc. A baseline neurological evaluation and then at every cycle is recommended.];Best Response Rate[Assessment of tumor response should be made every 4 cycles and at the end of the study (4 weeks following the completion of chemotherapy). Response is assessed by imaging methods (computed tomography [CT] scan).]