Co-treatment With GnRH Analogs on the Ovarian Reserve in Young Women Treated With Alkylating Agents for Cancer (PRESOV)
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|ClinicalTrials.gov Identifier: NCT02856048|
Recruitment Status : Active, not recruiting
First Posted : August 4, 2016
Last Update Posted : February 27, 2018
|Condition or disease||Intervention/treatment||Phase|
|Cancer Toxicity Due to Chemotherapy Sarcoma Osteosarcoma Lymphoma Ewing Sarcoma||Drug: Triptorelin (GnRHa) + Chemotherapy||Phase 2 Phase 3|
This is a French, Prospective, Multicentre, Open, Randomised study To determine the efficacy of a temporary ovarian suppression obtained by administration of a Gonadotropin Releasing Hormone agonist (GnRHa) on maintaining ovarian reserve, patients will be randomized, half of them receiving Triptorelin extended release (LP) 3 mg intramuscularly every 28±3 days, starting at the inclusion visit and at least 72 days before chemotherapy with alkylating agents until 1 month after end of chemotherapy (mean duration: 12 months).
The primary objective of the study is to determine the effect of a temporary ovarian suppression achieved through administration of a gonadotropin releasing hormone agonist (triptorelin LP 3 mg) during alkylating agents containing chemotherapy on ovarian reserve assessed by AMH serum levels in adolescents and young women with cancer.
Number of centres 19 Research period
- Recruitment duration 2 years
- The duration of participation of each patient is: 3 years
- The duration of the treatment period is: 1 year
- The duration of the follow-up period is: 2 years
- Total duration: 5 years
Sample size and design One Hundred and sixty (160) patients will be included in this study in order to ensure at least 128 patients who will complete the study.
This number of patients should allow us to identify with a power of 80 % a difference of 5 pmol/L in AMH serum levels between the two groups, when accepting a risk alpha of 0.05.
- Analysis populations The main analysis will be an intention-to-treat (ITT) analysis, which will be performed on all the randomized patients with a value of the main criterion of judgment (AMH level at M24). A per-protocol (PP) analysis will also be performed, as a secondary analysis, excluding patients with major protocol deviation defined a priori.
- Primary criteria The value of AMH level at month 24will be compared between the two treatment groups using a test t of Student if AMH values are normally distributed and a non-parametric Wilcoxon test if not.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||11 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Assessment of the Effect of a Co-treatment With GnRH Analogs on the Ovarian Reserve in Adolescents and Young Women Treated With Alkylating Agents for Cancer|
|Study Start Date :||November 2016|
|Estimated Primary Completion Date :||February 2021|
|Estimated Study Completion Date :||February 2021|
Experimental: Triptorelin (GnRHa) + Chemotherapy
Triptorelin LP 3 mg (DECAPEPTYL LP 3 mg, IPSEN) 3 mg every 28±3 days, intramuscular during chemotherapy
Drug: Triptorelin (GnRHa) + Chemotherapy
During her chemotherapy, the patient in the experimental arm will have regular injections of Triptorelin (DECAPEPTYL LP 3 mg, IPSEN) in order to preserve her fertility
Other Name: GnRH Agonist injections
No Intervention: Chemotherapy alone
Patient having a chemotherapy without drug injection for fertility preservation
- Variation in AMH serum levels between both groups [ Time Frame: at 24 months ]Centralised hormonal dosages
- Number of patients with AMH serum levels < 5th percentile in each group [ Time Frame: at 24 months ]
- Intra-patient variation in AMH serum levels between groups [ Time Frame: up to 36 months ]Centralised hormonal dosages and study of potential factors associated with the efficacy of GnRHa co-treatment in preventing ovarian reserve loss (if there is one)
- Antral Follicular Count (AFC) on ultrasound between the 2 groups [ Time Frame: at month 24 ]centralised blind evaluation by an independent reader on compact disc (CD) registration of AFC
- Delay of resumption of menses between the 2 groups [ Time Frame: up to the end of the follow up (an average of 3 years) ]Comparison of delay of resumption of menses between the 2 groups
- Levels of markers of ovarian reserve: AMH, Follicle-stimulating hormone (FSH), Estradiol between groups [ Time Frame: at months 12, 24 and 36 ]Centralised hormon dosage
- Pregnancy rate in the 2 groups [ Time Frame: up to the end of the follow up (an average of 3 years) ]
- Adverse events related to Triptorelin co-treatment [ Time Frame: up to the end of the follow up (an average of 3 years) ]
- Relative change in Bone Mass Density (BMD) of the lumbar spine, left femoral neck and whole body in the 2 groups [ Time Frame: at the baseline and at month 12 and month 36 ]centralised blind evaluation by an independent reader on CD registration of BMD assessed by dual-energy X-ray absorptiometry
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02856048
|AP-HP, Bicêtre Hospital|
|Le Kremlin Bicêtre, France, 94270|
|Principal Investigator:||Cecile THOMAS-TEINTURIER, MD||AP-HP, Bicêtre Hospital|