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Trial registered on ANZCTR


Registration number
ACTRN12610000309088
Ethics application status
Approved
Date submitted
1/04/2010
Date registered
19/04/2010
Date last updated
23/03/2011
Type of registration
Retrospectively registered

Titles & IDs
Public title
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
Scientific title
Carboplatin and Paclitaxel (Taxol) (8 cycles) versus Carboplatin and Paclitaxel (Taxol) (4 cycles) followed by Carboplatin (4 cycles) for frontline chemotherapy in advanced ovarian carcinoma. A randomised phase III study of overall survival by the Hellenic Cooperative Oncology Group
Secondary ID [1] 1574 0
Nil
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Advanced Ovarian Cancer 256995 0
Condition category
Condition code
Cancer 257149 257149 0 0
Ovarian and primary peritoneal

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
PACLITAXEL (TAXOL): 175mg/m2 intravenous (i.v.) over 3 hours (h) only on day 1 of each cycle, cycles 1 to 4
CARBOPLATIN: Area under the curve (AUC)6 i.v. over 1h only on day 1 of each cycle, cycles 1 to 4
Followed by
CARBOPLATIN: 6 AUC i.v. over 1h only on day 1 of each cycle, cycles 5 to 8

Duration of therapy: 1 day per cycle. Cycles are repeated every 21 days.
Intervention code [1] 256172 0
Treatment: Drugs
Comparator / control treatment
PACLITAXEL (TAXOL): 175mg/m2 i.v. over 3h only on Day 1 of each cycle, cycles 1 to 8
CARBOPLATIN: AUC 6 i.v. over 1h only on Day 1 of each cycle, cycles 1 to 8

Duration of therapy: 1 day per cycle. Cycles are repeated every 21 days.
Control group
Active

Outcomes
Primary outcome [1] 258106 0
Overall Survival (OS)
Timepoint [1] 258106 0
3 years following randomisation. This outcome is assessed using clinical data records
Secondary outcome [1] 263713 0
Disease-Free Survival (DFS)
Timepoint [1] 263713 0
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.
Secondary outcome [2] 263714 0
To compare toxicity (especially neuroroxicity) between the two treatment arms
Timepoint [2] 263714 0
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.
Secondary outcome [3] 263749 0
Best Response Rate
Timepoint [3] 263749 0
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).

Eligibility
Key inclusion criteria
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.
Minimum age
18 Years
Maximum age
No limit
Gender
Females
Can healthy volunteers participate?
No
Key exclusion criteria
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
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Who is / are masked / blinded?



Intervention assignment
Other design features
Phase
Phase 3
Type of endpoint(s)
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment outside Australia
Country [1] 2552 0
Greece
State/province [1] 2552 0

Funding & Sponsors
Funding source category [1] 256728 0
Other Collaborative groups
Name [1] 256728 0
Hellenic Cooperative Oncology Group
Address [1] 256728 0
18, Hatzikostandi str, 11524, Athens
Country [1] 256728 0
Greece
Primary sponsor type
Other Collaborative groups
Name
Hellenic Cooperative Oncology Group
Address
18, Hatzikostandi str, 11524, Athens
Country
Greece
Secondary sponsor category [1] 256012 0
None
Name [1] 256012 0
Address [1] 256012 0
Country [1] 256012 0

Ethics approval
Ethics application status
Approved

Summary
Brief summary
This is a randomized trial comparing carboplatin and paclitaxel (8 cycles) versus carboplatin and paclitaxel (4 cycles) followed by carboplatin (4 cycles) for frontline chemotherapy in advanced ovarian carcinoma.

The main objective is to evaluate overall survival and. secondary endpoints are to evaluate disease-free survival, best response rate and to compare toxicity (especially neuroroxicity), between the two treatment arms.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 30960 0
Address 30960 0
Country 30960 0
Phone 30960 0
Fax 30960 0
Email 30960 0
Contact person for public queries
Name 14207 0
Eleni Papakostaki
Address 14207 0
18, Hatzikostandi str, 11524, Athens
Country 14207 0
Greece
Phone 14207 0
00302106912520
Fax 14207 0
Email 14207 0
hecogoff@ondsl.gr
Contact person for scientific queries
Name 5135 0
Aristotelis Bamias
Address 5135 0
Alexandra Hospital, Department of Clinical Therapeutics, 80 Vas. SofiasAthens 11528
Country 5135 0
Greece
Phone 5135 0
+30 210 3381546
Fax 5135 0
Email 5135 0
abamias@med.uoa.gr

No information has been provided regarding IPD availability
Summary results
Have study results been published in a peer-reviewed journal?
Other publications
Have study results been made publicly available in another format?
Results – basic reporting
Results – plain English summary