Co-treatment With GnRH Analogs on the Ovarian Reserve in Young Women Treated With Alkylating Agents for Cancer
NCT ID: NCT02856048
Last Updated: 2019-12-17
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE2/PHASE3
11 participants
INTERVENTIONAL
2016-11-23
2021-02-28
Brief Summary
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Detailed Description
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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
Statistical analysis:
1. 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.
2. 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.
3. 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.
Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Triptorelin (GnRHa) + Chemotherapy
Triptorelin LP 3 mg (DECAPEPTYL LP 3 mg, IPSEN) 3 mg every 28±3 days, intramuscular during chemotherapy
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
Chemotherapy alone
Patient having a chemotherapy without drug injection for fertility preservation
No interventions assigned to this group
Interventions
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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 Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Puberty Tanner 2 or more
* Diagnosis of cancer: Sarcoma, Ewing, Osteosarcoma, Lymphoma
* Chemotherapy protocol with alkylating agents at an intermediate ovarian toxicity risk (Cyclophosphamide 6 g/m2, Ifosfamide 50 g/m2, Procarbazine 4 g/m2, Lomustine 350 mg/m2 or Melphalan 140 mg/m2 or a combination of these drugs).
* All patients with an osteosarcoma, Ewing sarcoma excepted pelvic localisation, Hodgkin lymphoma treatment group III (stages II B, III B and IV), B cell lymphoma group C, rhabdomyosarcoma treated with at least 8 Ifosfamide Vincristin Actinomycin (IVA) courses, synoviosarcoma group II T\>5 cm and group III, adult type sarcoma group I and II T\>5 cm and group III.
* Before starting any chemotherapy
* Covered by a medical insurance
Exclusion Criteria
* Pregnant
* Planned brain or pelvic radiotherapy
* Planned stem cell transplantation
* Ovariectomy
* Having already received chemotherapy with alkylating agents
* Hypersensitivity to any component of GnRHa
12 Years
25 Years
FEMALE
No
Sponsors
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Assistance Publique - Hôpitaux de Paris
OTHER
Responsible Party
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Principal Investigators
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Cecile THOMAS-TEINTURIER, MD
Role: PRINCIPAL_INVESTIGATOR
AP-HP, Bicêtre Hospital
Locations
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AP-HP, Bicêtre Hospital
Le Kremlin-Bicêtre, , France
Countries
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Other Identifiers
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2015-001121-17
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
P140932
Identifier Type: -
Identifier Source: org_study_id