Cancer Clinical Trial
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
The purpose of this study is to determine the efficacy of a temporary ovarian suppression obtained by administration of a gonadotropin releasing hormone agonist during alkylating agents containing chemotherapy on ovarian reserve assessed by Anti-Müllerian hormone (AMH) serum levels in adolescents and young women with cancer.
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
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.
;
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Recruiting |
NCT05346796 -
Survivorship Plan HEalth REcord (SPHERE) Implementation Trial
|
N/A | |
| Recruiting |
NCT05094804 -
A Study of OR2805, a Monoclonal Antibody Targeting CD163, Alone and in Combination With Anticancer Agents
|
Phase 1/Phase 2 | |
| Completed |
NCT04867850 -
Effect of Behavioral Nudges on Serious Illness Conversation Documentation
|
N/A | |
| Enrolling by invitation |
NCT04086251 -
Remote Electronic Patient Monitoring in Oncology Patients
|
N/A | |
| Completed |
NCT01285037 -
A Study of LY2801653 in Advanced Cancer
|
Phase 1 | |
| Completed |
NCT00680992 -
Study of Denosumab in Subjects With Giant Cell Tumor of Bone
|
Phase 2 | |
| Completed |
NCT00062842 -
Study of Irinotecan on a Weekly Schedule in Children
|
Phase 1 | |
| Active, not recruiting |
NCT04548063 -
Consent Forms in Cancer Research: Examining the Effect of Length on Readability
|
N/A | |
| Completed |
NCT04337203 -
Shared Healthcare Actions and Reflections Electronic Systems in Survivorship
|
N/A | |
| Recruiting |
NCT04349293 -
Ex-vivo Evaluation of the Reactivity of the Immune Infiltrate of Cancers to Treatments With Monoclonal Antibodies Targeting the Immunomodulatory Pathways
|
N/A | |
| Terminated |
NCT02866851 -
Feasibility Study of Monitoring by Web-application on Cytopenia Related to Chemotherapy
|
N/A | |
| Active, not recruiting |
NCT05304988 -
Development and Validation of the EFT for Adolescents With Cancer
|
||
| Completed |
NCT04448041 -
CRANE Feasibility Study: Nutritional Intervention for Patients Undergoing Cancer Surgery in Low- and Middle-Income Countries
|
||
| Completed |
NCT00340522 -
Childhood Cancer and Plexiform Neurofibroma Tissue Microarray for Molecular Target Screening and Clinical Drug Development
|
||
| Recruiting |
NCT04843891 -
Evaluation of PET Probe [64]Cu-Macrin in Cardiovascular Disease, Cancer and Sarcoidosis.
|
Phase 1 | |
| Active, not recruiting |
NCT03844048 -
An Extension Study of Venetoclax for Subjects Who Have Completed a Prior Venetoclax Clinical Trial
|
Phase 3 | |
| Completed |
NCT03167372 -
Pilot Comparison of N-of-1 Trials of Light Therapy
|
N/A | |
| Completed |
NCT03109041 -
Initial Feasibility Study to Treat Resectable Pancreatic Cancer With a Planar LDR Source
|
Phase 1 | |
| Terminated |
NCT01441115 -
ECI301 and Radiation for Advanced or Metastatic Cancer
|
Phase 1 | |
| Recruiting |
NCT06206785 -
Resting Energy Expenditure in Palliative Cancer Patients
|