CancerPhase 2/3PRESOVNCT02856048
Co-treatment With GnRH Analogs on the Ovarian Reserve in Young Women Treated With Alkylating Agents for Cancer
A Phase 2/3 study testing Triptorelin (GnRHa) + Chemotherapy in people with Cancer and Toxicity Due to Chemotherapy, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
Trial 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… Read more about this study
- Who is it for?
- Ages 12 to 25 years, women only
- Conditions the study is for
- Cancer, Toxicity Due to Chemotherapy, Sarcoma
- What is being tested?
- Triptorelin (GnRHa) + Chemotherapy
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 11 participants
- Where
- 1 siteFrance
- Study dates
- 23 Nov 2016to Feb 2021
- Phase
- Phase 2/3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 12 to 25 years
- Women only
- No healthy volunteers
- Child, Adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the detailed description
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:
- 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.
- Conditions
- Cancer, Toxicity Due to Chemotherapy, Sarcoma, Osteosarcoma, Lymphoma, Ewing Sarcoma
- Being tested
- Triptorelin (GnRHa) + Chemotherapy
- Keywords
- GnRH agonist, Ovarian reserve, Fertility Preservation, Alkylating Agents
- Medical subject headings
- Neoplasms, Sarcoma, Osteosarcoma, Lymphoma, Sarcoma, Ewing
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Triptorelin (GnRHa) + ChemotherapyDrug
Also called GnRH Agonist injections
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
| Study group | Role | What they receive |
|---|---|---|
| Triptorelin (GnRHa) + Chemotherapy | Experimental | Triptorelin LP 3 mg (DECAPEPTYL LP 3 mg, IPSEN) 3 mg every 28±3 days, intramuscular during chemotherapy Receives: Drug: Triptorelin (GnRHa) + Chemotherapy |
| Chemotherapy alone | No intervention | Patient having a chemotherapy without drug injection for fertility preservation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Variation in AMH serum levels between both groups
Centralised hormonal dosages
Measured: at 24 months
Secondary outcomes (8)
Number of patients with AMH serum levels < 5th percentile in each group
Measured: at 24 months
Intra-patient variation in AMH serum levels between groups
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)
Measured: up to 36 months
Antral Follicular Count (AFC) on ultrasound between the 2 groups
centralised blind evaluation by an independent reader on compact disc (CD) registration of AFC
Measured: at month 24
Delay of resumption of menses between the 2 groups
Comparison of delay of resumption of menses between the 2 groups
Measured: 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
Centralised hormon dosage
Measured: at months 12, 24 and 36
Pregnancy rate in the 2 groups
Measured: up to the end of the follow up (an average of 3 years)
Adverse events related to Triptorelin co-treatment
Measured: 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
centralised blind evaluation by an independent reader on CD registration of BMD assessed by dual-energy X-ray absorptiometry
Measured: at the baseline and at month 12 and month 36
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Aug 2016 (estimated)
- Study start23 Nov 2016
- Primary completionFeb 2021 (estimated)
- Study completionFeb 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CancerStudies of the same condition, open and under way.
- More trials run by Assistance Publique - Hôpitaux de ParisThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2/3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 11 participants (actual)
Sponsor and investigators
- Lead sponsor
- Assistance Publique - Hôpitaux de Paris
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Cecile THOMAS-TEINTURIER, MD, Principal investigator, AP-HP, Bicêtre Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02856048
- Sponsor's protocol ID
- P140932
- Other IDs
- 2015-001121-17, 2015
- Acronym
- PRESOV
- Status last verified
- Dec 2019
- First submitted
- 19 Jul 2016
- Last updated
- 17 Dec 2019
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Dec 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT02856048
- Acronym / sponsor ID
- PRESOV / P140932
- Conditions
- Cancer, Toxicity Due to Chemotherapy, Sarcoma, Osteosarcoma, Lymphoma, Ewing Sarcoma
- Keywords
- GnRH agonist, Ovarian reserve, Fertility Preservation, Alkylating Agents
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 11 participants (actual)
- Lead sponsor
- Assistance Publique - Hôpitaux de ParisUniversity, hospital or other
- Study start
- 23 Nov 2016 (actual)
- Primary completion
- Feb 2021 (estimated)
- Study completion
- Feb 2021 (estimated)
- First posted
- 4 Aug 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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:
- 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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Triptorelin (GnRHa) + Chemotherapy | Experimental | Drug: Triptorelin (GnRHa) + ChemotherapyTriptorelin LP 3 mg (DECAPEPTYL LP 3 mg, IPSEN) 3 mg every 28±3 days, intramuscular during chemotherapy |
| Chemotherapy alone | No intervention | –Patient having a chemotherapy without drug injection for fertility preservation |
Who may qualify
- Ages
- 12 to 25 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (7 listed)
- 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.
Key exclusion criteria (7 listed)
- Prepubertal
- Pregnant
- Planned brain or pelvic radiotherapy
- Planned stem cell transplantation
- Ovariectomy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Triptorelin (GnRHa) + ChemotherapyAlso: GnRH Agonist injectionsDuring 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 | Drug | Triptorelin (GnRHa) + Chemotherapy |
Primary outcome
Variation in AMH serum levels between both groups
Time frame: at 24 months
Centralised hormonal dosages
8 secondary outcomes
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
Antral Follicular Count (AFC) on ultrasound between the 2 groups
Time frame: at month 24
Delay of resumption of menses between the 2 groups
Time frame: 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
Time frame: at months 12, 24 and 36
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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Dec 2019.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Cecile THOMAS-TEINTURIER, MD principal investigator
AP-HP, Bicêtre Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing Triptorelin (GnRHa) + Chemotherapy in people with Cancer and Toxicity Due to Chemotherapy, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 17 Dec 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Variation in AMH serum levels between both groups (time frame: at 24 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Dec 2019.