SeminomaPhase 2SEMITEPNCT01887340
Therapeutic Strategy Guided by PET-TDM for Patients With Seminoma
A Phase 2 study testing Carboplatin, Etoposide and Cisplatin in people with Seminoma, run by Gustave Roussy, Cancer Campus, Grand Paris at 1 site in France.
Trial summary
The purpose of the study is to evaluate the ration of patients getting an lighten therapeutic strategy after 18F-fluoro-désoxyglucose positron emission tomography (PET-TDM) in grade I (cohort 1) or metastatic (cohort 2) seminoma Read more about this study
- Who is it for?
- Ages 18 years and older, men only
- Conditions the study is for
- Seminoma
- What is being tested?
- Carboplatin, Etoposide and Cisplatin
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 271 participants
- Where
- 1 siteFrance
- Study dates
- Jun 2013to Jun 2026
- 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 18 years and older
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Histologically proved seminoma after orchiectomy
- Primary testicular or retroperitoneal
- Normal alpha-fetoprotein before and after orchiectomy
- No prior treatment with radiotherapy or chemotherapy
- Age >= 18 years
- ECOG 0 to 2
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- PNN >= 1500, platelets >= 100 000, bilirubin <= the upper limit nromale
- ASAT (SGOT) and ALAT (SGPT) <= 1,5 x the upper limit nromale
- Serum creatinine <140 µmol / L (or clearance> 60 mL / min)
- Information and signed informed consent before inclusion in the study
- Patient affiliated to a social security
- Specific inclusion criteria for cohort 1:
- grade I
- Specific inclusion criteria for cohort 2:
- grade IIB (retroperitoneal adenopathy diameter between 2 cm and 5 cm, regardless of the LDH)
- grade IIC (retroperitoneal adenopathy diameter higher than 5 cm, regardless of the LDH)
- grade III of good prognosis (supradiaphragmatic reach with ganglionic metastasis and LDH < 2 times normal limit and/or supradiaphragmatic reach with pulmonary metastasis and LDH < 2 times normal limit) either at initial diagnosis or relapse of a grade I seminoma)
- PET-TDM positive (pathological fixation on metastatic lesions)
Who cannot join
- Patient infected by HIV, Hepatitis B or C
- History, within 5 years, of cancer other than seminoma, except for treated skin cancer (Basal Cell) .
- visceral metastasis
- cerebral metastasis
- Any physical or mental condition incompatible with the treatment (to the investigator discretion)
- Uncontrolled or severe cardiovascular pathology
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- Uncontrolled or severe hepatic pathology
- Persons deprived of liberty or under guardianship
- Unable to undergo medical monitoring due to geographical, social or psychological reasons
Trial locations and contacts
1 site in 1 country.
France1 site, 1 recruiting
- Recruiting
Gustave Roussy
Villejuif, Val de Marne, 94805
Yohann LORIOT, MD, 0142115276 ext. +33, yohann.loriot@gustaveroussy.fr
About this study
Official title: Therapeutic Strategy Guided by PET-TDM for Patients With Grade I or Metastatic Seminoma
The purpose of the study is to evaluate the ration of patients getting an lighten therapeutic strategy after 18F-fluoro-désoxyglucose positron emission tomography (PET-TDM) in grade I (cohort 1) or metastatic (cohort 2) seminoma
- Conditions
- Seminoma
- Being tested
- Carboplatin, Etoposide, Cisplatin
- Medical subject headings
- Seminoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CarboplatinDrug
- carboplatine: Dose (mg) = AUC x (GFR + 25)
- GFR : glomérulaire filtration (ml/min)
- AUC : area under curve (mg/ml x min)
EtoposideDrug
100 mg/m2 D1 to D5
CisplatinDrug
20 mg/m2 de D1 to D5
| Study group | Role | What they receive |
|---|---|---|
| Cohort 1 | Experimental | * PET-TDM
* carboplatine: Dose (mg) = AUC x (GFR + 25)
* GFR : glomérulaire filtration (ml/min)
* AUC : area under curve (mg/ml x min) Receives: Drug: Carboplatin |
| Cohort 2 | Experimental | * PET-TDM
* ETOPOSIDE (100 mg/m2 D1 to D5) and CISPLATINE (20 mg/m2 de D1 to D5)
* carboplatine: Dose (mg) = AUC x (GFR + 25)
* GFR : glomérulaire filtration (ml/min)
* AUC : area under curve (mg/ml x min) Receives: Drug: Carboplatin; Drug: Etoposide; Drug: Cisplatin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rate of patients without pathological fixation
Rate of patients without pathological fixation at the time of the inclusion PET-TDM (cohort 1) or at the time of the PET-TDM following two cycles of chemotherapy (Etoposiede+Cisplatine) (cohort 2) and getting a lighten protocol
Measured: Assessed at the time of inclusion or after 2 cycles of chemotherapy, up to 21 days
Secondary outcomes (2)
Rate of patients without pathological fixation
Rate of patients without pathological fixation at the time of the inclusion PET-TDM (cohort 1) or at the time of the PET-TDM following two cycles of chemotherapy (Etoposiede+Cisplatine) (cohort 2)
Measured: Assessed at the time of inclusion or after 2 cycles of chemotherapy, up to 21 days
Progression Free Survival (PFS)
Measured: Assessed up to 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jun 2013 (estimated)
- Study startJun 2013
- Primary completionJun 2016 (estimated)
- Study completionJun 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for SeminomaStudies 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 2
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 271 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Gustave Roussy, Cancer Campus, Grand Paris
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Yohann LORIOT, MD, Study chair, Gustave Roussy, Cancer Campus, Grand Paris
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01887340
- Sponsor's protocol ID
- 2012-A01615-38
- Other IDs
- 2012/1884
- Acronym
- SEMITEP
- Status last verified
- Jun 2016
- First submitted
- 24 Jun 2013
- Last updated
- 9 Jun 2016
- Results posted
- No
- Data monitoring committee
- No
Publications
Loriot Y, Texier M, Culine S, Flechon A, Thiery-Vuillemin A, Gravis G, Geoffrois L, Chevreau C, Gross-Goupil M, Barthelemy P, Bompas E, Mahammedi H, Laguerre B, Lacourtoisie SA, Helissey C, Ladoire S, Abraham C, Massard C, Grimaldi S, Fizazi K. The GETUG SEMITEP Trial: De-escalating Chemotherapy in Good-prognosis Seminoma Based on Fluorodeoxyglucose Positron Emission Tomography/Computed Tomography. Eur Urol. 2022 Aug;82(2):172-179. doi: 10.1016/j.eururo.2022.04.031. Epub 2022 May 20.
PubMed 35599187
Study at a glance
From the registry record, last updated by the sponsor on 9 Jun 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Therapeutic Strategy Guided by PET-TDM for Patients With Grade I or Metastatic Seminoma
- ClinicalTrials.gov ID
- NCT01887340
- Acronym / sponsor ID
- SEMITEP / 2012-A01615-38
- Conditions
- Seminoma
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 271 participants (estimated)
- Lead sponsor
- Gustave Roussy, Cancer Campus, Grand ParisUniversity, hospital or other
- Study start
- Jun 2013
- Primary completion
- Jun 2016 (estimated)
- Study completion
- Jun 2026 (estimated)
- First posted
- 26 Jun 2013 (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 the study is to evaluate the ration of patients getting an lighten therapeutic strategy after 18F-fluoro-désoxyglucose positron emission tomography (PET-TDM) in grade I (cohort 1) or metastatic (cohort 2) seminoma
Study design
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Cohort 1 | Experimental | Drug: Carboplatin* PET-TDM * carboplatine: Dose (mg) = AUC x (GFR + 25) * GFR : glomérulaire filtration (ml/min) * AUC : area under curve (mg/ml x min) |
| Cohort 2 | Experimental | Drug: Carboplatin, Drug: Etoposide, Drug: Cisplatin* PET-TDM * ETOPOSIDE (100 mg/m2 D1 to D5) and CISPLATINE (20 mg/m2 de D1 to D5) * carboplatine: Dose (mg) = AUC x (GFR + 25) * GFR : glomérulaire filtration (ml/min) * AUC : area under curve (mg/ml x min) |
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (18 listed)
- Histologically proved seminoma after orchiectomy
- Primary testicular or retroperitoneal
- Normal alpha-fetoprotein before and after orchiectomy
- No prior treatment with radiotherapy or chemotherapy
- Age >= 18 years
Key exclusion criteria (9 listed)
- Patient infected by HIV, Hepatitis B or C
- History, within 5 years, of cancer other than seminoma, except for treated skin cancer (Basal Cell) .
- visceral metastasis
- cerebral metastasis
- Any physical or mental condition incompatible with the treatment (to the investigator discretion)
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 |
|---|---|---|
| Carboplatin- carboplatine: Dose (mg) = AUC x (GFR + 25) * GFR : glomérulaire filtration (ml/min) * AUC : area under curve (mg/ml x min) | Drug | Cohort 1, Cohort 2 |
| Etoposide100 mg/m2 D1 to D5 | Drug | Cohort 2 |
| Cisplatin20 mg/m2 de D1 to D5 | Drug | Cohort 2 |
Primary outcome
Rate of patients without pathological fixation
Time frame: Assessed at the time of inclusion or after 2 cycles of chemotherapy, up to 21 days
Rate of patients without pathological fixation at the time of the inclusion PET-TDM (cohort 1) or at the time of the PET-TDM following two cycles of chemotherapy (Etoposiede+Cisplatine) (cohort 2) and getting a lighten protocol
2 secondary outcomes
Rate of patients without pathological fixation
Time frame: Assessed at the time of inclusion or after 2 cycles of chemotherapy, up to 21 days
Progression Free Survival (PFS)
Time frame: Assessed up to 5 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Jun 2016.
- Derived from this study: PubMed 35599187Loriot Y, Texier M, Culine S, Flechon A, Thiery-Vuillemin A, Gravis G, Geoffrois L, Chevreau C, Gross-Goupil M, Barthelemy P, Bompas E, Mahammedi H, Laguerre B, Lacourtoisie SA, Helissey C, Ladoire S, Abraham C, Massard C, Grimaldi S, Fizazi K. The GETUG SEMITEP Trial: De-escalating Chemotherapy in Good-prognosis Seminoma Based on Fluorodeoxyglucose Positron Emission Tomography/Computed Tomography. Eur Urol. 2022 Aug;82(2):172-179. doi: 10.1016/j.eururo.2022.04.031. Epub 2022 May 20.
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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.
Yohann LORIOT, MD study chair
Gustave Roussy, Cancer Campus, Grand Paris
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Carboplatin, Etoposide and Cisplatin in people with Seminoma, 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 9 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 9 Jun 2016. 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 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Yohann LORIOT, MD (0142115276 ext. +33, yohann.loriot@gustaveroussy.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Rate of patients without pathological fixation (time frame: Assessed at the time of inclusion or after 2 cycles of chemotherapy, up to 21 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01887340, which also lists 1 linked publication.
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 9 Jun 2016.