NCT02856048

Brief Summary

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
11

participants targeted

Target at below P25 for phase_2 cancer

Timeline
Completed

Started Nov 2016

Typical duration for phase_2 cancer

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 19, 2016

Completed
16 days until next milestone

First Posted

Study publicly available on registry

August 4, 2016

Completed
4 months until next milestone

Study Start

First participant enrolled

November 23, 2016

Completed
4.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2021

Completed
Last Updated

December 17, 2019

Status Verified

December 1, 2019

Enrollment Period

4.2 years

First QC Date

July 19, 2016

Last Update Submit

December 16, 2019

Conditions

CancerToxicity Due to ChemotherapySarcomaOsteosarcomaLymphomaEwing Sarcoma

Keywords

GnRH agonistOvarian reserveFertility PreservationAlkylating Agents

Outcome Measures

Primary Outcomes (1)

  • Variation in AMH serum levels between both groups

    Centralised hormonal dosages

    at 24 months

Secondary Outcomes (8)

  • Number of patients with AMH serum levels < 5th percentile in each group

    at 24 months

  • Intra-patient variation in AMH serum levels between groups

    up to 36 months

  • Antral Follicular Count (AFC) on ultrasound between the 2 groups

    at month 24

  • Delay of resumption of menses between the 2 groups

    up to the end of the follow up (an average of 3 years)

  • Levels of markers of ovarian reserve: AMH, Follicle-stimulating hormone (FSH), Estradiol between groups

    at months 12, 24 and 36

  • +3 more secondary outcomes

Study Arms (2)

Triptorelin (GnRHa) + Chemotherapy

EXPERIMENTAL

Triptorelin LP 3 mg (DECAPEPTYL LP 3 mg, IPSEN) 3 mg every 28±3 days, intramuscular during chemotherapy

Drug: Triptorelin (GnRHa) + Chemotherapy

Chemotherapy alone

NO INTERVENTION

Patient having a chemotherapy without drug injection for fertility preservation

Interventions

Triptorelin (GnRHa) + ChemotherapyDRUG

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

Also known as: GnRH Agonist injections
Triptorelin (GnRHa) + Chemotherapy

Eligibility Criteria

Age12 Years - 25 Years
Sexfemale
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • Female aged 12 to 25 years
  • 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

You may not qualify if:

  • Prepubertal
  • Pregnant
  • Planned brain or pelvic radiotherapy
  • Planned stem cell transplantation
  • Ovariectomy
  • Having already received chemotherapy with alkylating agents
  • Hypersensitivity to any component of GnRHa

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

AP-HP, Bicêtre Hospital

Le Kremlin-Bicêtre, 94270, France

Location

MeSH Terms

Conditions

NeoplasmsSarcomaOsteosarcomaLymphomaSarcoma, Ewing

Interventions

Triptorelin PamoateDrug Therapy

Condition Hierarchy (Ancestors)

Neoplasms, Connective and Soft TissueNeoplasms by Histologic TypeNeoplasms, Bone TissueNeoplasms, Connective TissueLymphoproliferative DisordersLymphatic DiseasesHemic and Lymphatic DiseasesImmunoproliferative DisordersImmune System Diseases

Intervention Hierarchy (Ancestors)

Gonadotropin-Releasing HormonePituitary Hormone-Releasing HormonesHypothalamic HormonesPeptide HormonesHormonesHormones, Hormone Substitutes, and Hormone AntagonistsNeuropeptidesPeptidesAmino Acids, Peptides, and ProteinsOligopeptidesNerve Tissue ProteinsProteinsTherapeutics

Study Officials

  • Cecile THOMAS-TEINTURIER, MD

    AP-HP, Bicêtre Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 19, 2016

First Posted

August 4, 2016

Study Start

November 23, 2016

Primary Completion

February 1, 2021

Study Completion

February 1, 2021

Last Updated

December 17, 2019

Record last verified: 2019-12

Data Sharing

IPD Sharing
Will not share

Locations

FR(1)