Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12609001059257
Ethics application status
Approved
Date submitted
23/04/2009
Date registered
10/12/2009
Date last updated
20/06/2012
Type of registration
Prospectively registered

Titles & IDs
Public title
Women undergoing chemotherapy plus gonadotrophin-releasing hormone (GnRH) analouges compared with control to protect ovairan function
Scientific title
Gonadotropin-releasing hormone analogue cotreatment does not preserve ovarian function in young women receiving cyclophosphamide-based chemotherapy: a prospective, multicenter, randomized trial
Secondary ID [1] 1183 0
NA
Universal Trial Number (UTN)
U1111-1112-7798
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Women of reproductive age receiving chemotherapy 4584 0
Cancer 252349 0
Condition category
Condition code
Reproductive Health and Childbirth 237058 237058 0 0
Fertility including in vitro fertilisation
Cancer 252497 252497 0 0
Breast

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
As part of a multicenter randomized trial, participants will be stratified according to the timing of their first presentation(Women requiring early chemotherapy will be randomly allocated to receive either early chemotherapy alone (EC Control) or GnRH-ant (Cetrotide0.25 mg, cetrorelix, Merck Serono, Switzerland) and GnRH-ag (Decapeptyl CR, triptorelin 3.75 mg, Ferring, Switzerland) combination followed by chemotherapy (EC GnRH) when down-regulation (E2<50 pg/ml) is confirmed with discontinuation of GnRH-ant and continuation of triptorelin every 4 weeks until end of chemotherapy

When chemotherapy is planned to start later than 10 days, women will be randomized to receive either chemotherapy alone (DC Control) or GnRH-ag followed by chemotherapy (DC GnRH) after confirmation of down-regulation (E2<50 pg/ml) with continuation of agonist until end of chemotherapy.



FAC regime will be used in all participants (IV 5-flourouracil (500\m2), adriamycin, (50mg\m2) and cyclophosphamide (500mg\m2) every 21 days for six cycle in absence of disease progression or toxicity. Adverse events will be assessed clinically and by means of hematologic and biochemical measurements. Lymph node dissection wil bel performed on a case-by-case basis. Regional adjuvant radiotherapy will be allowed.
Intervention code [1] 4349 0
Prevention
Comparator / control treatment
there are 2 contol groups taking chemotherapy only.
first. in women coming to start early chemotherapy, there is contol group taking only chemotherapy vs active taking antagonist/agonist plus chemo

second. women coming to start delayed chemo are submitted to receive either delayed chemo only (control) or agonist followed by chemo
Control group
Active

Outcomes
Primary outcome [1] 253383 0
Resumption of menstruation at 12 months after end of chemotherapy was the primary outcome
Timepoint [1] 253383 0
Up to 18 months after completion of chemotherapy at 6-month intervals
Secondary outcome [1] 241677 0
Antimullerian hormone levels via standardized laboratory quantification procedures
Timepoint [1] 241677 0
Before starting chemotherapy and 12 months after completion of chemotherapy
Secondary outcome [2] 262469 0
serum follicle-stimulating hormone (FSH), luteinizing hormone (LH) and 17b-estradiol (E2) via standardized laboratory quantification procedures
Timepoint [2] 262469 0
Six and 12 months following completion of chemotherapy
Secondary outcome [3] 262569 0
Transvaginal evaluation antral follicle count
Timepoint [3] 262569 0
Six and 12 months following completion of chemotherapy

Eligibility
Key inclusion criteria
Women between 18 and 40 years old receiving cyclophosphamide-based chemotherapy for treatment of cancer with presence of both ovaries and absence of ovarian tumours or cysts over 40 mm in diameter demonstrated by transvaginal ultrasound
Minimum age
18 Years
Maximum age
40 Years
Sex
Females
Can healthy volunteers participate?
No
Key exclusion criteria
Advanced stage disease or evidence of metastases; Cancer of the ovaries, uterus, or fallopian tubes; Women who previously received chemotherapy or abdominal/pelvic radiation or are planned to receive abdomino-pelvic radiation; Patients taking hormone therapy biologic therapy or corticosteroids; Women who are pregnant or nursing.

Study design
Purpose of the study
Prevention
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Sequentially numbered, dark, sealed envelopes
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Computer-generated randomization
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Phase 2
Type of endpoint/s
Safety/efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
15/12/2009
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
100
Accrual to date
Final
Recruitment outside Australia
Country [1] 1724 0
Egypt
State/province [1] 1724 0
Zagazig (School of Medicine, Zagazig University)
Country [2] 1725 0
Egypt
State/province [2] 1725 0
Cairo (National Cancer Institute, Cairo University)

Funding & Sponsors
Funding source category [1] 4774 0
University
Name [1] 4774 0
Zagazig University School of Medicine
Country [1] 4774 0
Egypt
Funding source category [2] 256105 0
Charities/Societies/Foundations
Name [2] 256105 0
Alexandria Regional center for Women Health
Country [2] 256105 0
Egypt
Primary sponsor type
University
Name
Ass. Prof. Dr. Eman Elgindy
Address
Department of Obstetrics & Gynaecology, , Zagazig University School of Medicine, Zagazig
Country
Egypt
Secondary sponsor category [1] 251451 0
University
Name [1] 251451 0
Prof. Dr. Dhalia El-Haig
Address [1] 251451 0
Department of Obstetrics & Gynaecology, , Zagazig University School of Medicine, Zagazig
Country [1] 251451 0
Egypt
Secondary sponsor category [2] 251479 0
University
Name [2] 251479 0
Prof. Dr. Hassan Sallam
Address [2] 251479 0
Department of Obstetrics & Gynaecology
Alexandria University School of Medicine
Alexandria
Country [2] 251479 0
Egypt
Secondary sponsor category [3] 251485 0
University
Name [3] 251485 0
Dr. Ola Khorshid
Address [3] 251485 0
National Cancer Institute
Cairo University
Cairo
Country [3] 251485 0
Egypt

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 258190 0
Zagazig University School of Medicine
Ethics committee address [1] 258190 0
Zagazig University School of Medicine, Zagazig
Ethics committee country [1] 258190 0
Egypt
Date submitted for ethics approval [1] 258190 0
Approval date [1] 258190 0
26/05/2009
Ethics approval number [1] 258190 0

Summary
Brief summary
Cancer is not uncommon in women of reproductive age. Women diagnosed with cancer during their reproductive period are often concerned not only with the uncertainty of long-term survival, but also with the potential loss of fertility as a result of cancer treatment. A combination of gonadotrophin-releasing hormone (GnRH) analogue administrations with cyclophosphamide-based chemotherapy may provide protection to the woman's ovaries during treatment. We wished to determine this in a multi-center, open label controlled trial of 100 reproductive age women needing chemotherapy.
Trial website
NA
Trial related presentations / publications
NA
Public notes

Contacts
Principal investigator
Name 29480 0
Address 29480 0
Country 29480 0
Phone 29480 0
Fax 29480 0
Email 29480 0
Contact person for public queries
Name 12727 0
Eman Elgindy, MD
Address 12727 0
Department of Obstetrics & Gynaecology, Zagazig University School of Medicine,
Zagazig
Country 12727 0
Egypt
Phone 12727 0
+20-12-7491143
Fax 12727 0
Email 12727 0
eaelgindy@zu.edu.eg
Contact person for scientific queries
Name 3655 0
Eman Elgindy, MD
Address 3655 0
Department of Obstetrics & Gynaecology, Zagazig University School of Medicine, Zagazig

Zagazig
Country 3655 0
Egypt
Phone 3655 0
+20-12-7491143
Fax 3655 0
Email 3655 0
eaelgindy@zu.edu.eg

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
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