Testicular NeoplasmsPhase 2NCT02161692
Conventional Dose Versus High Dose Sequential Chemotherapy for Poor Prognosis Germ Cell Tumors
A Phase 2 study testing Cyclophosphamide, Etoposide and Cisplatin in people with Testicular Neoplasms and Germ Cell Tumors, run by Fondazione IRCCS Istituto Nazionale dei Tumori, Milano at 1 site in Italy.
Trial summary
The purpose of this study is to determine whether the use of a sequential high dose chemotherapy is more effective than conventional dose (i.e. 4 cycles of cisplatin, etoposide, and bleomycin [PEB]) in patients with metastatic poor prognosis germ cell tumors. Read more about this study
- Who is it for?
- Ages 18 to 75 years, men only
- Conditions the study is for
- Testicular Neoplasms, Germ Cell Tumors
- What is being tested?
- Cyclophosphamide, Etoposide and Cisplatin
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- Not given
- Where
- 1 siteItaly
- Study dates
- Dec 1996to Apr 2009
- 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 to 75 years
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Clinical or Histological diagnosis of germ cell tumors
- Metastatic disease
- Poor prognostic category according to the International Germ Cell Collaborative Group (IGCCCG) classification
- No prior chemotherapy for metastatic disease
Who cannot join
- Unwillingness to accomplish the study procedures
- Any existing co-morbidity that could limit the administration of high dose chemotherapy
- Any psychiatric disorder that could impact on the study compliance
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Randomized Phase 2 Study of Conventional Dose Chemotherapy Versus High Dose Sequential Chemotherapy as First-line Therapy for Metastatic Poor Prognosis Germ Cell Tumors
The purpose of this study is to determine whether the use of a sequential high dose chemotherapy is more effective than conventional dose (i.e. 4 cycles of cisplatin, etoposide, and bleomycin [PEB]) in patients with metastatic poor prognosis germ cell tumors.
- Conditions
- Testicular Neoplasms, Germ Cell Tumors
- Being tested
- Cyclophosphamide, Etoposide, Cisplatin, Bleomycin, Carboplatin
- Medical subject headings
- Testicular Neoplasms, Neoplasms, Germ Cell and Embryonal
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CyclophosphamideDrug
EtoposideDrug
CisplatinDrug
BleomycinDrug
CarboplatinDrug
High dose carboplatin
| Study group | Role | What they receive |
|---|---|---|
| High dose chemotherapy | Experimental | Characterized by the following sequence:
High dose cyclophosphamide (7 grams/squared meter) x 1 cycle 2 cycles of high-dose etoposide and cisplatin
1 cycle of high dose carboplatin (Area Under the Curve 27) with stem cell rescue Receives: Drug: Cyclophosphamide; Drug: Etoposide; Drug: Cisplatin; Drug: Carboplatin |
| Conventional dose chemotherapy | Active comparator | Cisplatin, Etoposide, and Bleomycin (PEB) x 4 cycles Receives: Drug: Etoposide; Drug: Cisplatin; Drug: Bleomycin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Evidence of disease progression confirmed by computed tomography (CT) scan and/or serum tumor markers.
Measured: 5 years
Secondary outcomes (1)
Overall survival
Measured: 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jun 2014 (estimated)
- Study startDec 1996
- Primary completionMay 2007
- Study completionApr 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Testicular NeoplasmsStudies 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
Sponsor and investigators
- Lead sponsor
- Fondazione IRCCS Istituto Nazionale dei Tumori, Milano
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Andrea Necchi, Fondazione IRCCS Istituto Nazionale dei Tumori, Milano
- Investigators
- Andrea Necchi, MD, Principal investigator, Istituto Nazionale dei Tumori, Milano Italy
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02161692
- Sponsor's protocol ID
- INT48/96
- Status last verified
- Jun 2014
- First submitted
- 10 Jun 2014
- Last updated
- 12 Jun 2014
- Results posted
- No
- Data monitoring committee
- No
Publications
Lorch A, Bascoul-Mollevi C, Kramar A, Einhorn L, Necchi A, Massard C, De Giorgi U, Flechon A, Margolin K, Lotz JP, Germa-Lluch JR, Powles T, Kollmannsberger C, Beyer J. Conventional-dose versus high-dose chemotherapy as first salvage treatment in male patients with metastatic germ cell tumors: evidence from a large international database. J Clin Oncol. 2011 Jun 1;29(16):2178-84. doi: 10.1200/JCO.2010.32.6678. Epub 2011 Mar 28.
PubMed 21444870Necchi A, Mariani L, Di Nicola M, Lo Vullo S, Nicolai N, Giannatempo P, Raggi D, Fare E, Magni M, Piva L, Matteucci P, Catanzaro M, Biasoni D, Torelli T, Stagni S, Bengala C, Barone C, Schiavetto I, Siena S, Carlo-Stella C, Pizzocaro G, Salvioni R, Gianni AM. High-dose sequential chemotherapy (HDS) versus PEB chemotherapy as first-line treatment of patients with poor prognosis germ-cell tumors: mature results of an Italian randomized phase II study. Ann Oncol. 2015 Jan;26(1):167-172. doi: 10.1093/annonc/mdu485. Epub 2014 Oct 24.
PubMed 25344361
Study at a glance
From the registry record, last updated by the sponsor on 12 Jun 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Phase 2 Study of Conventional Dose Chemotherapy Versus High Dose Sequential Chemotherapy as First-line Therapy for Metastatic Poor Prognosis Germ Cell Tumors
- ClinicalTrials.gov ID
- NCT02161692
- Acronym / sponsor ID
- INT48/96
- Conditions
- Testicular Neoplasms, Germ Cell Tumors
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Lead sponsor
- Fondazione IRCCS Istituto Nazionale dei Tumori, MilanoUniversity, hospital or other
- Study start
- Dec 1996
- Primary completion
- May 2007 (actual)
- Study completion
- Apr 2009 (actual)
- First posted
- 12 Jun 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 purpose of this study is to determine whether the use of a sequential high dose chemotherapy is more effective than conventional dose (i.e. 4 cycles of cisplatin, etoposide, and bleomycin [PEB]) in patients with metastatic poor prognosis germ cell tumors.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| High dose chemotherapy | Experimental | Drug: Cyclophosphamide, Drug: Etoposide, Drug: Cisplatin, Drug: CarboplatinCharacterized by the following sequence: High dose cyclophosphamide (7 grams/squared meter) x 1 cycle 2 cycles of high-dose etoposide and cisplatin 1 cycle of high dose carboplatin (Area Under the Curve 27) with stem cell rescue |
| Conventional dose chemotherapy | Active comparator | Drug: Etoposide, Drug: Cisplatin, Drug: BleomycinCisplatin, Etoposide, and Bleomycin (PEB) x 4 cycles |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Clinical or Histological diagnosis of germ cell tumors
- Metastatic disease
- Poor prognostic category according to the International Germ Cell Collaborative Group (IGCCCG) classification
- No prior chemotherapy for metastatic disease
Key exclusion criteria (3 listed)
- Unwillingness to accomplish the study procedures
- Any existing co-morbidity that could limit the administration of high dose chemotherapy
- Any psychiatric disorder that could impact on the study compliance
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 |
|---|---|---|
| Cyclophosphamide | Drug | High dose chemotherapy |
| Etoposide | Drug | Conventional dose chemotherapy, High dose chemotherapy |
| Cisplatin | Drug | Conventional dose chemotherapy, High dose chemotherapy |
| Bleomycin | Drug | Conventional dose chemotherapy |
| CarboplatinHigh dose carboplatin | Drug | High dose chemotherapy |
Primary outcome
Evidence of disease progression confirmed by computed tomography (CT) scan and/or serum tumor markers.
Time frame: 5 years
1 secondary outcome
Overall survival
Time frame: 5 years
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 12 Jun 2014.
- Background: PubMed 21444870Lorch A, Bascoul-Mollevi C, Kramar A, Einhorn L, Necchi A, Massard C, De Giorgi U, Flechon A, Margolin K, Lotz JP, Germa-Lluch JR, Powles T, Kollmannsberger C, Beyer J. Conventional-dose versus high-dose chemotherapy as first salvage treatment in male patients with metastatic germ cell tumors: evidence from a large international database. J Clin Oncol. 2011 Jun 1;29(16):2178-84. doi: 10.1200/JCO.2010.32.6678. Epub 2011 Mar 28.
- Derived from this study: PubMed 25344361Necchi A, Mariani L, Di Nicola M, Lo Vullo S, Nicolai N, Giannatempo P, Raggi D, Fare E, Magni M, Piva L, Matteucci P, Catanzaro M, Biasoni D, Torelli T, Stagni S, Bengala C, Barone C, Schiavetto I, Siena S, Carlo-Stella C, Pizzocaro G, Salvioni R, Gianni AM. High-dose sequential chemotherapy (HDS) versus PEB chemotherapy as first-line treatment of patients with poor prognosis germ-cell tumors: mature results of an Italian randomized phase II study. Ann Oncol. 2015 Jan;26(1):167-172. doi: 10.1093/annonc/mdu485. Epub 2014 Oct 24.
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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.
Andrea Necchi, MD principal investigator
Istituto Nazionale dei Tumori, Milano Italy
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 Cyclophosphamide, Etoposide and Cisplatin in people with Testicular Neoplasms and Germ Cell Tumors, run by Fondazione IRCCS Istituto Nazionale dei Tumori, Milano at 1 site in Italy.
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 4 inclusion and 3 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 12 Jun 2014. 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 Italy. 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?
Evidence of disease progression confirmed by computed tomography (CT) scan and/or serum tumor markers. (time frame: 5 years). 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 NCT02161692, which also lists 2 linked publications.
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 12 Jun 2014.