Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12607000329460
Ethics application status
Approved
Date submitted
16/06/2007
Date registered
19/06/2007
Date last updated
20/03/2018
Type of registration
Prospectively registered

Titles & IDs
Public title
Phase III Randomized Trial of Maintenance Pegylated Liposomal Doxorubicin (PLD)/ Carboplatin versus without in Patients with Advanced Ovarian Cancer
Scientific title
Patients with Advanced Ovarian Cancer with complete remission after first-line chemotherapy-Maintenance Pegylated Liposomal Doxorubicin (PLD) / Carboplatin versus observation-time to progression, quality of life and toxicity of treatment-progression free survival
Secondary ID [1] 375 0
AGOG06-001
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Advanced ovarian cancer 1878 0
Condition category
Condition code
Cancer 1972 1972 0 0
Ovarian and primary peritoneal

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Maintenance Pegylated Liposomal Doxorubicin (PLD) 30mg/m2/ Carboplatin Area Under the Curve = 4 in 28-day cycles for 6 courses versus observation (no treatment) after complete remission of first-line chemotherapy.
Intervention code [1] 1833 0
Treatment: Drugs
Comparator / control treatment
Control group
Active

Outcomes
Primary outcome [1] 2789 0
Progression-free survival
Timepoint [1] 2789 0
At baseline, by history and Physical Exam/Pelvic exam on every visit, and abdominal pelvic CT scan at baseline and every year from the start of treatment until progression during the study (including clinical suspicion).
Secondary outcome [1] 4709 0
Overall survival, Quality-of-Life, safety profile
Timepoint [1] 4709 0
At baseline, by history and PE/PV on every visit and abdominal pelvic CT scan at baseline and every year from the start of treatment until progression during the study (including clinical suspicion).

Eligibility
Key inclusion criteria
To be eligible for inclusion, each patient must fulfill all of the following criteria:a. histologically proven ovarian cancer of International Federation of Gynecology and Obstetrics stage III/IVb. treatment with five to six cycles of Paclitaxol / Platinum regimenc. attainment of a clinical defined complete response (ie, no cancer-related symptom ; normal physical examination, CT scan of the abdominal/pelvis and chest x-ray ; CA-125 level < 35 U/mL) d. performance status of Eastern Cooperative Oncology Group 0, 1, 2 e. adequate hematopoietic function is defined as below:- Absolute Neutrophil Count > 1,500/uL- Platelets > 100,000/uLf. adequate organ function is defined as below:- Total bilirubin < 1.5 X Upper Limit of Normal (ULN)- Alanine aminotranferase / Aspartate aminotransferase < 1.5 X ULN (<5.0 x ULN if hepatic metastasis) - Serum creatinine < 1.5 × ULNg. age 20-75 years oldh. life expectancy equal or longer than 3 monthsi. ability to understand and willingness to sign a written informed consent document
Minimum age
20 Years
Maximum age
75 Years
Sex
Females
Can healthy volunteers participate?
No
Key exclusion criteria
a. presence of CNS metastases (including clinical suspicion)b. other malignancy with exception of curative treated non-melanoma skin cancer or cervical carcinoma in situ within 5 years prior to entering the studyc. presence of other serious concomitant illness which can affect or elevate the value of CA-125, e.g.;- Autoimmune disease- Sarcoidosis- Chronic active hepatitis- Pericarditis- Cirrhosis of liver- Abdominal tuberculosis- Pancratitisd. presence of other serious concomitant illness which might be aggravated by study medication:- Uncontrolled infection (active serious infections that are not controlled by antibiotics)- Active cardiac disease e.g. decompensate myocardial infarction within the 6-month period preceding entry into the study.- History of ventricular arrhythmia or congestive heart failure.e. surgery within 2 weeks prior to entering the studyf. radiotherapy within 4 weeks prior to entering the studyg. concurrent chemotherapy, radiotherapy, or other investigational drug except non-disease related conditions (e.g. insulin for diabetes) during study periodh. mental status is not fit for clinical triali. pregnant or breast feeding womenj. potential child-bearing women unless using a reliable and appropriate contraceptive method.

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)
Allocation concealment will be applied. A central randomisation by phone/fax/computerpermuted block randomization will be employed to generate the randomization scheme for an approximate equal number of patients between two treatment groups.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Computerised sequence generation will be used. Each randomization number will be assigned to individual patient according to the sequence for screened patient becomes eligible.Stratification : (1) residual tumor after primary surgery (> 1cm or = 1cm) (2) baseline CA125 <10, 10-25 , >25-35 u/mL
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Phase 3
Type of endpoint/s
Safety/efficacy
Statistical methods / analysis
Total sample size will be revised to total 122 evaluable subjects.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
21/06/2007
Actual
21/06/2007
Date of last participant enrolment
Anticipated
Actual
30/09/2014
Date of last data collection
Anticipated
Actual
31/01/2018
Sample size
Target
122
Accrual to date
Final
45
Recruitment outside Australia
Country [1] 10230 0
Taiwan, Province Of China
State/province [1] 10230 0
Taoyuan, Kaohsiung, Chiayi, Taichung
Country [2] 10231 0
India
State/province [2] 10231 0
Bangalore

Funding & Sponsors
Funding source category [1] 2112 0
Commercial sector/Industry
Name [1] 2112 0
TTY BIOPHARM COMPANY LIMITED
Country [1] 2112 0
Taiwan, Province Of China
Primary sponsor type
Hospital
Name
Chang Gung Memorial Hospital
Address
5 Fu-Shin St., Kueishan, Taoyuan 33305, Taiwan
Country
Taiwan, Province Of China
Secondary sponsor category [1] 1921 0
Other Collaborative groups
Name [1] 1921 0
Asian Gynecologic Oncology Group
Address [1] 1921 0
5 Fu-Shin St. Kueishan, Taoyuan 33305, Taiwan
Country [1] 1921 0
Taiwan, Province Of China
Secondary sponsor category [2] 298271 0
Government body
Name [2] 298271 0
Ministry of Health and Welfare, Taiwan
Address [2] 298271 0
No. 488, Sec. 6, Zhongxiao E. Rd., Nangang Dist., Taipei, Taiwan
Country [2] 298271 0
Taiwan, Province Of China

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 3904 0
IRB of Chang Gung Memorial Hospital
Ethics committee address [1] 3904 0
Ethics committee country [1] 3904 0
Taiwan
Date submitted for ethics approval [1] 3904 0
Approval date [1] 3904 0
05/01/2007
Ethics approval number [1] 3904 0
95-0761A
Ethics committee name [2] 299973 0
Ethics committee address [2] 299973 0
B2F, No. 123, Dinghu Rd., Guishan Dist., Taoyuan City 333, Taiwan
Ethics committee country [2] 299973 0
Taiwan, Province Of China
Date submitted for ethics approval [2] 299973 0
Approval date [2] 299973 0
Ethics approval number [2] 299973 0
95-0761A
Ethics committee name [3] 299974 0
Institutional Ethical Review Board, St. John's Medical College Hospital
Ethics committee address [3] 299974 0
IERB office Ground floor, college Building, St. John's Medical College Hospital
Sarjapur Road, Koranangala, Banglore - 560 034, India
Ethics committee country [3] 299974 0
India
Date submitted for ethics approval [3] 299974 0
01/08/2009
Approval date [3] 299974 0
10/08/2009
Ethics approval number [3] 299974 0
IERB/1/529/09

Summary
Brief summary
In the current study, we will use Lipo-Dox® in combination with carboplatin as maintenance chemotherapy in advanced epithelial ovarian patients who have achieved clinical complete remission after 5-6 courses of taxane/platinum based first-line chemotherapy.
All eligible subjects will randomize to arm A or arm B.
Arm A:
Subjects will receive PLD(Lipo-Dox) 30 mg/m2 intravenously (iv) over 1 hour on day 1 and follow by Carboplatin 4 AUC intravenous infusion for 30 minutes in a 28-day cycle for maximum six cycles.
Arm B:
Subjects will not receive any treatment.
Therapeutic Assessment includes progression free survival, quality-of-life, overall survival, and safety profiles.
Trial website
Trial related presentations / publications
Public notes
A revison of sample size was submitted. The revision was approved on 21/03/2014 with ID 103-0725C.

Contacts
Principal investigator
Name 27647 0
Prof Chyong-Huey Lai
Address 27647 0
Department of Obstetrics and Gynecology Chang Gung Memorial Hospital Linkou Medical Center 5 Fu-Shin St. Kueishan Taoyuan 33305
Country 27647 0
Taiwan, Province Of China
Phone 27647 0
+88633281200
Fax 27647 0
Email 27647 0
[email protected]
Contact person for public queries
Name 11022 0
Prof Chyong-Huey Lai, MD
Address 11022 0
Department of Obstetrics and Gynecology Chang Gung Memorial Hospital Linkou Medical Center 5 Fu-Shin St. Kueishan Taoyuan 33305
Country 11022 0
Taiwan, Republic Of China
Phone 11022 0
886-3-3281200
Fax 11022 0
886-3-3288252
Email 11022 0
[email protected]
Contact person for scientific queries
Name 1950 0
Prof Chyong-Huey Lai, MD
Address 1950 0
Department of Obstetrics and Gynecology Chang Gung Memorial Hospital Linkou Medical Center 5 Fu-Shin St. Kueishan Taoyuan 33305
Country 1950 0
Taiwan, Province Of China
Phone 1950 0
886-3-3281200
Fax 1950 0
886-3-3288252
Email 1950 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
SourceTitleYear of PublicationDOI
EmbasePegylated liposomal doxorubicin for relapsed epithelial ovarian cancer.2013https://dx.doi.org/10.1002/14651858.CD006910.pub2
N.B. These documents automatically identified may not have been verified by the study sponsor.