Extra Cranial Non Seminomateous Malignant Germ Cell TumourPhase 2NCT02104986
A Multicenter Study to Evaluate a Risk-adapted Strategy for Treatment of Extra Cranial Non Seminomateous Malignant Germ Cell Tumour in Children and Adolescent
A Phase 2 study testing Velbe-Bleomycin-Cisplatin and Vepeside-ifosfamide-Cisplatin in people with Extra Cranial Non Seminomateous Malignant Germ Cell Tumour, run by Centre Leon Berard at 27 sites in France.
Trial summary
The main objective is to assess the benefit-risk ratio of a risk-adapted strategy for treatment of extra cranial NSMGCT in children and adolescent. Read more about this study
- Who is it for?
- Ages Up to 18 years
- Conditions the study is for
- Extra Cranial Non Seminomateous Malignant Germ Cell Tumour
- What is being tested?
- Velbe-Bleomycin-Cisplatin and Vepeside-ifosfamide-Cisplatin
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 117 participants
- Where
- 27 sitesFrance
- Study dates
- 12 May 2014to 14 Oct 2021
- Phase
- Phase 2
- 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 Up to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Extra cranial non seminomateous malignant germ cell tumour (NSMGCT) except pure immature teratoma.
- Age ≤ 18 years.
- Affiliation with a social security scheme.
- Signed informed consent by parents
- Effective contraception during the study if relevant .
Who cannot join
- Previous chemotherapy
- Contraindications to study treatments
- Patient who cannot follow medical surveillance due to geographical, social, or psychological reasons
- Pregnant and breast feeding women
Trial locations and contacts
27 sites in 1 country.
27 sites in 1 country
France27 sites
CHU
Amiens, 80054
CHU
Angers, 49033
CHRU
Besançon, 25030
CHU
Bordeaux, 33076
Chu Morvan
Brest, 26609
CHU
Caen, 14033
Chu Estaing
Clermont-Ferrand, 63003
CHU
Dijon, 21079
Centre Oscar Lambret
Lille, 59000
CHU
Limoges, 87042
Hopital de La Timone
Marseille, 13385
CHU
Montpellier, 34295
CHU
Nancy, 54511
CHU
Nantes, 44093
CHU
Nice, 06202
Institut Curie
Paris, 75005
Hopital Trousseau
Paris, 75012
CHU
Poitiers, 86021
CHU
Reims, 51092
CHU
Rennes, 35203
CHU
Rouen, 76031
Hopital Felix Guyon
Saint-Denis, 97405
CHRU
Saint-Etienne, 42055
CHRU
Strasbourg, 67098
CHU
Toulouse, 31059
CHRU
Tours, 37044
Institut Gustave Roussy
Villejuif, 94805
About this study
The main objective is to assess the benefit-risk ratio of a risk-adapted strategy for treatment of extra cranial NSMGCT in children and adolescent.
Read the detailed description
Two different situations will be considered:
- in NSMGCT patients treated with cisplatin-based chemotherapy, the objective is to maintain a 2-year progression-free survival rate >80% despite a limitation of the number of course of chemotherapy (≤4) after the achievement of a clinical and biological response (primary endpoint);
- in children over 10 years with testicular or extragonadal NSMGCT, the objective is to improve the overall survival by systematically classifying the patients in high-risk group to allow a dose intensification.
- Being tested
- Velbe-Bleomycin-Cisplatin, Vepeside-ifosfamide-Cisplatin
- Keywords
- non seminomateous malignant germ cell tumour (NSMGCT), Dose De-escalation, Chemotherapy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Velbe-Bleomycin-CisplatinDrug
Also called Desescalation
Limitation of the number of chemotherapy courses (≤ 4) after the achievement of a clinical and biological response in NSMGCT patients treated with cisplatin-based chemotherapy, in order to reduce treatment long-term effects
Vepeside-ifosfamide-CisplatinDrug
| Study group | Role | What they receive |
|---|---|---|
| 3 courses of Velbe-Bleomycin-Cisplatin | Experimental | 3 VBP (Velbe-Bleomycin-Cisplatin) Risk-adapted strategy - reduction of the number of chemotherapy courses Receives: Drug: Velbe-Bleomycin-Cisplatin |
| 4 courses of Velbe-Bleomycin-Cisplatin | Experimental | 4 VBP (Velbe-Bleomycin-Cisplatin) Risk-adapted strategy - reduction of the number of chemotherapy courses Receives: Drug: Velbe-Bleomycin-Cisplatin |
| 3 courses Vepeside-ifosfamide-Cisplatin | Experimental | 3 VIP (Vepeside-ifosfamide-Cisplatin) Risk-adapted strategy - reduction of the number of chemotherapy courses Receives: Drug: Vepeside-ifosfamide-Cisplatin |
| 4 courses Vepeside-ifosfamide-Cisplatin | Experimental | 4 VIP (Vepeside-ifosfamide-Cisplatin) Risk-adapted strategy - reduction of the number of chemotherapy courses Receives: Drug: Vepeside-ifosfamide-Cisplatin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Progression-free survival
Measured: 24 months
Secondary outcomes (2)
Overall survival
Measured: Within 10 years after the first inclusion, from the date of inclusion to the date of death due to any cause
complete remission rate after 1st line treatment (chemotherapy and surgery)
Measured: 3 weeks after the end of treatment (CT + surgery)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Apr 2014 (estimated)
- Study start12 May 2014
- Primary completion14 Oct 2021
- Study completion14 Oct 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Extra Cranial Non Seminomateous Malignant Germ Cell TumourStudies of the same condition, open and under way.
- 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
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 117 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre Leon Berard
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Cécile CONTER, MD, Principal investigator, Centre Léon Bérard, Lyon, FRANCE
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02104986
- Sponsor's protocol ID
- TGM 2013-NS
- Status last verified
- Aug 2022
- First submitted
- 27 Mar 2014
- Last updated
- 29 Aug 2022
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 29 Aug 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter Study to Evaluate a Risk-adapted Strategy for Treatment of Extra Cranial Non Seminomateous Malignant Germ Cell Tumour in Children and Adolescent
- ClinicalTrials.gov ID
- NCT02104986
- Acronym / sponsor ID
- TGM 2013-NS
- Keywords
- non seminomateous malignant germ cell tumour (NSMGCT), Dose De-escalation, Chemotherapy
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 117 participants (actual)
- Lead sponsor
- Centre Leon BerardUniversity, hospital or other
- Study start
- 12 May 2014 (actual)
- Primary completion
- 14 Oct 2021 (actual)
- Study completion
- 14 Oct 2021 (actual)
- First posted
- 7 Apr 2014 (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 main objective is to assess the benefit-risk ratio of a risk-adapted strategy for treatment of extra cranial NSMGCT in children and adolescent.
Detailed description
Two different situations will be considered:
- in NSMGCT patients treated with cisplatin-based chemotherapy, the objective is to maintain a 2-year progression-free survival rate >80% despite a limitation of the number of course of chemotherapy (≤4) after the achievement of a clinical and biological response (primary endpoint);
- in children over 10 years with testicular or extragonadal NSMGCT, the objective is to improve the overall survival by systematically classifying the patients in high-risk group to allow a dose intensification.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| 3 courses of Velbe-Bleomycin-Cisplatin | Experimental | Drug: Velbe-Bleomycin-Cisplatin3 VBP (Velbe-Bleomycin-Cisplatin) Risk-adapted strategy - reduction of the number of chemotherapy courses |
| 4 courses of Velbe-Bleomycin-Cisplatin | Experimental | Drug: Velbe-Bleomycin-Cisplatin4 VBP (Velbe-Bleomycin-Cisplatin) Risk-adapted strategy - reduction of the number of chemotherapy courses |
| 3 courses Vepeside-ifosfamide-Cisplatin | Experimental | Drug: Vepeside-ifosfamide-Cisplatin3 VIP (Vepeside-ifosfamide-Cisplatin) Risk-adapted strategy - reduction of the number of chemotherapy courses |
| 4 courses Vepeside-ifosfamide-Cisplatin | Experimental | Drug: Vepeside-ifosfamide-Cisplatin4 VIP (Vepeside-ifosfamide-Cisplatin) Risk-adapted strategy - reduction of the number of chemotherapy courses |
Who may qualify
- Ages
- Up to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (5 listed)
- Extra cranial non seminomateous malignant germ cell tumour (NSMGCT) except pure immature teratoma.
- Age ≤ 18 years.
- Affiliation with a social security scheme.
- Signed informed consent by parents
- Effective contraception during the study if relevant .
Key exclusion criteria (4 listed)
- Previous chemotherapy
- Contraindications to study treatments
- Patient who cannot follow medical surveillance due to geographical, social, or psychological reasons
- Pregnant and breast feeding women
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 |
|---|---|---|
| Velbe-Bleomycin-CisplatinAlso: DesescalationLimitation of the number of chemotherapy courses (≤ 4) after the achievement of a clinical and biological response in NSMGCT patients treated with cisplatin-based chemotherapy, in order to reduce treatment long-term effects | Drug | 3 courses of Velbe-Bleomycin-Cisplatin, 4 courses of Velbe-Bleomycin-Cisplatin |
| Vepeside-ifosfamide-Cisplatin | Drug | 3 courses Vepeside-ifosfamide-Cisplatin, 4 courses Vepeside-ifosfamide-Cisplatin |
Primary outcome
Progression-free survival
Time frame: 24 months
2 secondary outcomes
Overall survival
Time frame: Within 10 years after the first inclusion, from the date of inclusion to the date of death due to any cause
complete remission rate after 1st line treatment (chemotherapy and surgery)
Time frame: 3 weeks after the end of treatment (CT + surgery)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Aug 2022.
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.
Cécile CONTER, MD principal investigator
Centre Léon Bérard, Lyon, FRANCE
27 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Velbe-Bleomycin-Cisplatin and Vepeside-ifosfamide-Cisplatin in people with Extra Cranial Non Seminomateous Malignant Germ Cell Tumour, run by Centre Leon Berard at 27 sites 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 5 inclusion and 4 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: finished, as of the sponsor's last update on 29 Aug 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 27 sites 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 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.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Progression-free survival (time frame: 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 29 Aug 2022.