Trial Review

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers
Trial registered on ANZCTR


Registration number
ACTRN12606000300572
Ethics application status
Approved
Date submitted
9/12/1994
Date registered
9/12/1994
Date last updated
9/12/1994
Type of registration
Retrospectively registered

Titles & IDs
Public title
Does the addition of tamoxifen to standard chemotherapy improve the time to progression of disease in women with advanced ovarian cancer?
Scientific title
An open, randomised controlled phase III clinical trial investigating whether the addition of tamoxifen to cisplatin (or carboplatin) and cyclophosphamide for the treatment of International Federation of Gynecology and Obstetrics (FIGO) Stage III and IV advanced carcinoma of the ovary improves time to disease progression
Secondary ID [1] 12 0
National Clinical Trials Registry: NCTR85
Universal Trial Number (UTN)
Trial acronym
AO 8971
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Advanced carcinoma of the ovary 12 0
Condition category
Condition code
Cancer 12 12 0 0
Ovarian and primary peritoneal

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Arm B: Cisplatin (or carboplatin) + cyclophosphamide + tamoxifen orally 20mg twice a day for 5 years
Intervention code [1] 1099 0
Treatment: Drugs
Comparator / control treatment
Arm A: Cisplatin (or carboplatin) + cyclophosphamide
Control group
Active

Outcomes
Primary outcome [1] 24 0
Time to disease progression
Timepoint [1] 24 0
Secondary outcome [1] 36 0
Clinical response rate
Timepoint [1] 36 0
Measured by 3 monthly Ca125 levels
Secondary outcome [2] 37 0
Surgical response rate
Timepoint [2] 37 0
Measured by second look laparotomy after completion of chemotherapy
Secondary outcome [3] 38 0
Incidence of recurrence
Timepoint [3] 38 0
After a complete surgical response
Secondary outcome [4] 39 0
Survival time
Timepoint [4] 39 0

Eligibility
Key inclusion criteria
Histologically confirmed advanced epithelial carcinoma of the ovary (FIGO Stage III or IV), excluding tumours of low malignant potential. ECOG performance status 0 to 3. No previous systemic chemotherapy or radiotherapy. No history of other malignancies apart from skin cancer or adequately treated carcinoma-in-situ of the cervix. Adequate bone marrow function, viz. white cell count > 4.0 x 10^9/L, platelets > 100 x 10^9/L. Adequate renal function, viz. serum creatinine < 0.15 mmol/L (for patients to be given cisplatin) or creatinine clearance > 0.4 ml/sec (for patients to be given carboplatin). Suitable for follow-up- Informed consent, according to the Ethics Committee requirements of each institution, must be obtained. Surgery must have been performed within the previous 6 weeks. The dimensions of the largest residual tumour deposit(s) must at the conclusion of primary surgery must be known.
Minimum age
No limit
Maximum age
No limit
Sex
Females
Can healthy volunteers participate?
No
Key exclusion criteria
No exclusion criteria

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)
Central randomisation using sealed opaque envelopes
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomisation by using a randomisation table from a statistic book
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Phase 3
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
1/01/1989
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
230
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 14 0
Charities/Societies/Foundations
Name [1] 14 0
Cancer charity
Country [1] 14 0
Primary sponsor type
Charities/Societies/Foundations
Name
The Cancer Council Victoria
Address
Country
Australia
Secondary sponsor category [1] 12 0
Charities/Societies/Foundations
Name [1] 12 0
Clinical Oncological Society of Australia (COSA)
Address [1] 12 0
Country [1] 12 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 147 0
Anti-Cancer Council of Victoria
Ethics committee address [1] 147 0
Ethics committee country [1] 147 0
Australia
Date submitted for ethics approval [1] 147 0
Approval date [1] 147 0
Ethics approval number [1] 147 0
Ethics committee name [2] 148 0
Freemasons Hospital Melbourne
Ethics committee address [2] 148 0
Ethics committee country [2] 148 0
Australia
Date submitted for ethics approval [2] 148 0
Approval date [2] 148 0
Ethics approval number [2] 148 0
Ethics committee name [3] 149 0
Mercy Hospital for Women Melbourne
Ethics committee address [3] 149 0
Ethics committee country [3] 149 0
Australia
Date submitted for ethics approval [3] 149 0
Approval date [3] 149 0
Ethics approval number [3] 149 0
Ethics committee name [4] 150 0
Monash Medical Centre Melbourne
Ethics committee address [4] 150 0
Ethics committee country [4] 150 0
Australia
Date submitted for ethics approval [4] 150 0
Approval date [4] 150 0
Ethics approval number [4] 150 0
Ethics committee name [5] 151 0
Peter MacCallum Cancer Institute Melbourne
Ethics committee address [5] 151 0
Ethics committee country [5] 151 0
Australia
Date submitted for ethics approval [5] 151 0
Approval date [5] 151 0
Ethics approval number [5] 151 0
Ethics committee name [6] 152 0
Royal Womens Hospital Melbourne
Ethics committee address [6] 152 0
Ethics committee country [6] 152 0
Australia
Date submitted for ethics approval [6] 152 0
Approval date [6] 152 0
Ethics approval number [6] 152 0
Ethics committee name [7] 153 0
Westmead Hospital Sydney
Ethics committee address [7] 153 0
Ethics committee country [7] 153 0
Australia
Date submitted for ethics approval [7] 153 0
Approval date [7] 153 0
Ethics approval number [7] 153 0

Summary
Brief summary
This study was for patients who had advanced carcinoma of the ovary. The clinical trial compared carbo/cisplatin and cyclophosphamide chemotherapy alone with carbo/cisplatin and cyclophosphamide chemotherapy with the addition of 5 years of tamoxifen hormone treatment. The combination of carbo/cisplatin and cyclophosphamide was the standard treatment for advanced ovarian cancer. Tamoxifen showed marked activity against ovarian cancer when used on its own but it was not known if adding it to the standard treatment would improve disease free survival. Patients were randomly assigned to one of the treatments to assess if either would be a better treatment for ovarian cancer with acceptable side effects.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 36049 0
Address 36049 0
Country 36049 0
Phone 36049 0
Fax 36049 0
Email 36049 0
Contact person for public queries
Name 10288 0
Deb Howell
Address 10288 0
The Cancer Council Victoria
1 Rathdowne Street
Carlton VIC 3053
Country 10288 0
Australia
Phone 10288 0
+61 (0)3 9635 5179
Fax 10288 0
+61 (0)3 9635 5410
Email 10288 0
[email protected]
Contact person for scientific queries
Name 1216 0
Dr Robert Rome
Address 1216 0
Suite 209
320 Victoria Parade
East Melbourne Vic 3002
Country 1216 0
Australia
Phone 1216 0
+61 (0)3 9418 8128
Fax 1216 0
+61 (0)3 9418 8130
Email 1216 0
[email protected]

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.