Non-Seminomatous Germ Cell TumorVAPORNCT05705687
Validation of a Treatment Algorithm for Poor-Risk NSGCTnon Seminomatous Germ-cell Tumors
A study testing BEP Protocol, Dose-dense regimen and Early tumor resection or HD-CT in people with Non-Seminomatous Germ Cell Tumor, run by Gustave Roussy, Cancer Campus, Grand Paris at 1 site in France.
Trial summary
This is a prospective multicenter, non-randomized research program that includes: a phase IV study (for all patients) with a collection of tissue specimens of tumor, a phase II study (for patients with primary mediastinal tumors and an unfavorable decline in tumor markers), and a diagnostic study (for all patients… Read more about this study
- Who is it for?
- Ages 16 years and older, men only
- Conditions the study is for
- Non-Seminomatous Germ Cell Tumor
- What is being tested?
- BEP Protocol, Dose-dense regimen and Early tumor resection or HD-CT
- Type of treatment
- Pill or oral medicine, Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 150 participants
- Where
- 1 siteFrance
- Study dates
- 5 May 2023to Feb 2037
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 16 years and older
- Men only
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Male patient older than 16 years old on day of signing informed consent
- Patient with evidence of NSGCT based on histologic examination or based on clinical evidence and elevated serum hCG or AFP levels (in case of clinical emergency, therapy can be started before pathologic sample is obtained if tumor markers are highly elevated)
- Patient with testicular, retroperitoneal, or mediastinal primary site
- Patient with evidence of disseminated disease (clinical stages II or III according to AJCC 8th edition)
- Patient with disease classified as poor prognosis according to IGCCCG criteria:
- Primary mediastinal NSGCT or,
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- Non-pulmonary visceral metastases or,
- hCG > 50 000 UI/L, or AFP > 10 000 ng/mL, or LDH > 10 times the upper normal value
- Patient with adequate renal function: measured or calculated (by Cockcroft formula) creatinine clearance > 60 mL/min. Cockcroft formula: CrCl = [(140-age) x weight in kg]/[72 x serum creatinine (mg/dL)]
- Patient with absolute granulocyte count > or = 1,500/mm^3, platelets > or = 100,000 mm^3, bilirubin < or = 1.5x the upper limit of normal value.
- Patient with a contra-indication of undergoing any brain MRI are eligible, but will not be part of the diagnostic study part
- Patient (and his legal guardian for under-18 patient) who had understood, signed and dated the informed consent form
- Patient affiliated to social security system or beneficiary of the same
- Male of child-bearing potential, must agree to use two methods (one for the patient and one for the partner) of medically acceptable forms of contraception during the study and for 6 months after the last treatment intake.
- Inclusion criteria specific to the phase 2 study in patients with unfavorable serum marker decrease and mediastinal primary tumor (to be confirmed before the end of the 1st BEP cycle)
- Patient (and his legal guardian for under-18 patient) who had understood, signed and dated the specific Phase II informed consent form
- Patient with mediastinal primary site
- Patient with unfavorable serum marker decrease evaluated at D18-D21 of the first BEP-chemotherapy
Who cannot join
- Patient infected by the Human Immunodeficiency Virus (HIV)
- Patient under guardianship or deprived of his liberty by a judicial or administrative decision or incapable of giving its consent
- Patient with prior chemotherapy. Patients who have received a first cycle of cisplatin-base chemotherapy (BEP) for their poor-prognosis NSGCT are eligible as far as tumor marker decline can be assessed at day 18-21.
- Patient with previous malignancy, except for basal-cell carcinoma of the skin
- Known allergy or hypersensitivity to any of the study drugs
- Non inclusion criteria specific to the phase 2 study in patients with unfavorable serum marker decrease and mediastinal primary tumor (to be confirmed before the end of the 1st BEP cycle)
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- Patient (and his legal guardian for under-18 patient) who withdraws his consent
- Patient with Human T-cell Leukemia Virus (HTLV) type 1 and 2
- Patient with Hepatitis B surface antigen
- Patient with Hepatitis C antibody
- Patient with prior high-dose chemotherapy (HDCT) plus hematopoietic stem cell HSCs transplant
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
France1 site, 1 recruiting
- Recruiting
Gustave Roussy
Villejuif, 94800
Karim FIZAZI, MD, +33 (0)1 42 11 42 11, karim.fizazi@gustaveroussy.fr
About this study
Official title: A Prospective Program Aiming at Improving Outcome for Young Adults With Poor-prognosis
This is a prospective multicenter, non-randomized research program that includes:
- a phase IV study (for all patients) with a collection of tissue specimens of tumor,
- a phase II study (for patients with primary mediastinal tumors and an unfavorable decline in tumor markers),
- and a diagnostic study (for all patients, except patients with brain metastases at baseline or patients for whom any brain MRI is contra-indicated).
Read more
The main question it aims to answer is improving outcome for young adults with poor-prognosis Non Seminomatous Germ Cell Tumor (NSGCT) is to validate prospectively the efficacy and safety of a personalized treatment based on early tumor marker kinetic assessment in real life for patients with poor-prognosis NSGCT.
Participants will be followed-up according to the assessment of decline kinetics of the tumor markers at the end of a first chemotherapy cycle and according to the localisation of the primary lesion if unfavorable.
- In the case of a patient with a favorable decline of the tumor markers, he will be treated by 3 additional standard chemotherapy cycles.
- In the case of a patient with a testicular or peritoneal primary tumor and an unfavorable decline of the tumor markers, the patient will be treated by a dose-dense standard therapy.
- The patient with a mediastinal primary tumor and an unfavorable decline of the tumor markers will be proposed to enter the phase II part of the study or to enter the dose-dense regimen like the other primary localisations. If the patient consents and is eligible for phase II part, he will undergo either an early surgery if feasible or a high-dose chemotherapy if the early surgery is not possible.
- Conditions
- Non-Seminomatous Germ Cell Tumor
- Being tested
- BEP Protocol, Dose-dense regimen, Early tumor resection or HD-CT
- Medical subject headings
- Nonseminomatous germ cell tumor
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BEP ProtocolDrug
Also called Dose-dense protocol, Early surgery or high-dose chemotherapy
anticancer therapy
Dose-dense regimenDrug
T-BEP-Oxaliplatin followed by Cisplatin - Ifosfamide - Paclitaxel
Early tumor resection or HD-CTProcedure or surgery
TIP protocol + early surgery or high-dose chemotherapy if surgery not feasible or metastatic disease
| Study group | Role | What they receive |
|---|---|---|
| Favorable-BEP group | Other | Favorable decline of tumor markers
3 subsequent cycles of protocol BEP every 3 weeks
* Cisplatin 20 mg/m2/day IV x 5 days (D1 to D5),
* Etoposide 100 mg/m2/day IV x 5 days (D1 to D5)
* Bleomycin 30 mg/day IV or IM D1, D8, and D15. Receives: Drug: BEP Protocol |
| Unfavorable-dose-dense group | Other | Unfavorable decline of tumor markers, testicular or peritoneal primary tumor
2 cycles every 3 weeks of :
* Paclitaxel 175 mg/m2 IV over 3 hours on Day 1,
* Cisplatin 20 mg/m2/day IV x 5 days (D1 to D5),
* Etoposide 100 mg/m2/day IV x 5 days (D1 to D5)
* Bleomycin 30 mg/day IV or IM D1, D8, and D15.
* Oxaliplatin 130 mg/m2 IV over 3 hours, given on Day 10,
* G-CSF 263 microg/day SC, to be started one day after chemotherapy and stopped one day before the next scheduled chemotherapy cycle (D6-7, D9, D11-14, D16-20).
Then, 2 cycles every 3 weeks of :
* Cisplatin 100 mg/m2 IV over 2 hours on Day 1,
* Bleomycin 25 mg/day, by continuous IV infusion over 24 hours for 5 days from Day 10 to Day 14,
* Ifosfamide 2 g/m2 IV over 3 hours on Days 10, 12, and 14,
* Mesna 500 mg/m2 IV at time-points 0, 3, 7 and 11 hours on the days when ifosfamide is administered (mesna could also be given orally),
* G-CSF 263 microg/day SC on Days 2 to 9 and Days 16 to 20. Receives: Drug: Dose-dense regimen |
| Unfavorable-phase II group | Experimental | Unfavorable decline of tumor markers, mediastinal primary tumor, proposal to the patient to enter the phase II part. If patient refusal or ineligible for phase II group, the patient will enter the Unfavorable-dose-dense group.
1 additional cycle of
* Paclitaxel 250 mg/m² on Day 1 over the day,
* Ifosfamide 1,5 mg/m²,
* Mesna 500 mg/m2 IV at time-points 0, 3, 7 and 11 hours on the days when ifosfamide is administered (mesna could also be given orally),
* Cisplatin 25 mg/m² from Day 1 to Day 5,
* Collection of HSC.
Then
* if no metastases are detectable and the resection is technically feasible : early surgery whenever possible, followed by 2 additional cycles of TIP chemotherapy every 3 weeks
* if surgery is not possible or in case of metastatic disease : HDCT (including 3 cycles of the CE regimen (carboplatin AUC 8, using the Calvert formula, from Day 1 to Day 3 and etoposide 400 mg/m² from Day 1 to Day 3)) plus HSC support, followed by surgery of residual deposits. Receives: Procedure: Early tumor resection or HD-CT |
What is being measured
The primary outcome is the main question the study is designed to answer.
Progression-free survival
Progression-free survival
Measured: From date of registration until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 108 months after treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Jan 2023
- Study start5 May 2023
- Primary completionFeb 2031 (estimated)
- Study completionFeb 2037 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Non-Seminomatous Germ Cell TumorStudies of the same condition, open and under way.
- More trials run by Gustave Roussy, Cancer Campus, Grand 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 N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Gustave Roussy, Cancer Campus, Grand Paris
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05705687
- Sponsor's protocol ID
- 2023-505040-19-00
- Other IDs
- CSET 2021/3282, 2023
- Acronym
- VAPOR
- Status last verified
- May 2025
- First submitted
- 17 Jan 2023
- Last updated
- 8 May 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 8 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective Program Aiming at Improving Outcome for Young Adults With Poor-prognosis
- ClinicalTrials.gov ID
- NCT05705687
- Acronym / sponsor ID
- VAPOR / 2023-505040-19-00
- Conditions
- Non-Seminomatous Germ Cell Tumor
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- Gustave Roussy, Cancer Campus, Grand ParisUniversity, hospital or other
- Study start
- 5 May 2023 (actual)
- Primary completion
- Feb 2031 (estimated)
- Study completion
- Feb 2037 (estimated)
- First posted
- 31 Jan 2023 (actual)
- 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.
This is a prospective multicenter, non-randomized research program that includes:
- a phase IV study (for all patients) with a collection of tissue specimens of tumor,
- a phase II study (for patients with primary mediastinal tumors and an unfavorable decline in tumor markers),
- and a diagnostic study (for all patients, except patients with brain metastases at baseline or patients for whom any brain MRI is contra-indicated).
The main question it aims to answer is improving outcome for young adults with poor-prognosis Non Seminomatous Germ Cell Tumor (NSGCT) is to validate prospectively the efficacy and safety of a personalized treatment based on early tumor marker kinetic assessment in real life for patients with poor-prognosis NSGCT.
Participants will be followed-up according to the assessment of decline kinetics of the tumor markers at the end of a first chemotherapy cycle and according to the localisation of the primary lesion if unfavorable.
- In the case of a patient with a favorable decline of the tumor markers, he will be treated by 3 additional standard chemotherapy cycles.
- In the case of a patient with a testicular or peritoneal primary tumor and an unfavorable decline of the tumor markers, the patient will be treated by a dose-dense standard therapy.
- The patient with a mediastinal primary tumor and an unfavorable decline of the tumor markers will be proposed to enter the phase II part of the study or to enter the dose-dense regimen like the other primary localisations. If the patient consents and is eligible for phase II part, he will undergo either an early surgery if feasible or a high-dose chemotherapy if the early surgery is not possible.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Favorable-BEP group | Other | Drug: BEP ProtocolFavorable decline of tumor markers 3 subsequent cycles of protocol BEP every 3 weeks * Cisplatin 20 mg/m2/day IV x 5 days (D1 to D5), * Etoposide 100 mg/m2/day IV x 5 days (D1 to D5) * Bleomycin 30 mg/day IV or IM D1, D8, and D15. |
| Unfavorable-dose-dense group | Other | Drug: Dose-dense regimenUnfavorable decline of tumor markers, testicular or peritoneal primary tumor 2 cycles every 3 weeks of : * Paclitaxel 175 mg/m2 IV over 3 hours on Day 1, * Cisplatin 20 mg/m2/day IV x 5 days (D1 to D5), * Etoposide 100 mg/m2/day IV x 5 days (D1 to D5) * Bleomycin 30 mg/day IV or IM D1, D8, and D15. * Oxaliplatin 130 mg/m2 IV over 3 hours, given on Day 10, * G-CSF 263 microg/day SC, to be started one day after chemotherapy and stopped one day before the next scheduled chemotherapy cycle (D6-7, D9, D11-14, D16-20). Then, 2 cycles every 3 weeks of : * Cisplatin 100 mg/m2 IV over 2 hours on Day 1, * Bleomycin 25 mg/day, by continuous IV infusion over 24 hours for 5 days from Day 10 to Day 14, * Ifosfamide 2 g/m2 IV over 3 hours on Days 10, 12, and 14, * Mesna 500 mg/m2 IV at time-points 0, 3, 7 and 11 hours on the days when ifosfamide is administered (mesna could also be given orally), * G-CSF 263 microg/day SC on Days 2 to 9 and Days 16 to 20. |
| Unfavorable-phase II group | Experimental | Procedure: Early tumor resection or HD-CTUnfavorable decline of tumor markers, mediastinal primary tumor, proposal to the patient to enter the phase II part. If patient refusal or ineligible for phase II group, the patient will enter the Unfavorable-dose-dense group. 1 additional cycle of * Paclitaxel 250 mg/m² on Day 1 over the day, * Ifosfamide 1,5 mg/m², * Mesna 500 mg/m2 IV at time-points 0, 3, 7 and 11 hours on the days when ifosfamide is administered (mesna could also be given orally), * Cisplatin 25 mg/m² from Day 1 to Day 5, * Collection of HSC. Then * if no metastases are detectable and the resection is technically feasible : early surgery whenever possible, followed by 2 additional cycles of TIP chemotherapy every 3 weeks * if surgery is not possible or in case of metastatic disease : HDCT (including 3 cycles of the CE regimen (carboplatin AUC 8, using the Calvert formula, from Day 1 to Day 3 and etoposide 400 mg/m² from Day 1 to Day 3)) plus HSC support, followed by surgery of residual deposits. |
Who may qualify
- Ages
- 16 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (18 listed)
- Male patient older than 16 years old on day of signing informed consent
- Patient with evidence of NSGCT based on histologic examination or based on clinical evidence and elevated serum hCG or AFP levels (in case of clinical emergency, therapy can be started before pathologic sample is obtained if tumor markers are highly elevated)
- Patient with testicular, retroperitoneal, or mediastinal primary site
- Patient with evidence of disseminated disease (clinical stages II or III according to AJCC 8th edition)
- Patient with disease classified as poor prognosis according to IGCCCG criteria:
Key exclusion criteria (11 listed)
- Patient infected by the Human Immunodeficiency Virus (HIV)
- Patient under guardianship or deprived of his liberty by a judicial or administrative decision or incapable of giving its consent
- Patient with prior chemotherapy. Patients who have received a first cycle of cisplatin-base chemotherapy (BEP) for their poor-prognosis NSGCT are eligible as far as tumor marker decline can be assessed at day 18-21.
- Patient with previous malignancy, except for basal-cell carcinoma of the skin
- Known allergy or hypersensitivity to any of the study drugs
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 |
|---|---|---|
| BEP ProtocolAlso: Dose-dense protocol, Early surgery or high-dose chemotherapyanticancer therapy | Drug | Favorable-BEP group |
| Dose-dense regimenT-BEP-Oxaliplatin followed by Cisplatin - Ifosfamide - Paclitaxel | Drug | Unfavorable-dose-dense group |
| Early tumor resection or HD-CTTIP protocol + early surgery or high-dose chemotherapy if surgery not feasible or metastatic disease | Procedure or surgery | Unfavorable-phase II group |
Primary outcome
Progression-free survival
Time frame: From date of registration until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 108 months after treatment
Progression-free survival
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 May 2025.
- Individual participant dataSharing planned: Undecided
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing BEP Protocol, Dose-dense regimen and Early tumor resection or HD-CT in people with Non-Seminomatous Germ Cell Tumor, run by Gustave Roussy, Cancer Campus, Grand 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 18 inclusion and 11 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: looking for participants now, as of the sponsor's last update on 8 May 2025. 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.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Elodie LECERF, MSc (+33 (0)1 42 11 42 11, elodie.lecerf@gustaveroussy.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Progression-free survival (time frame: From date of registration until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 108 months after treatment). 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 8 May 2025.