Germ Cell TumorPhase 2TIPNCT02414685
First Line TIP in Poor Prognosis TGCTs.
A Phase 2 study testing Paclitaxel, Ifosfamide and Cisplatin in people with Germ Cell Tumor, run by National Cancer Institute, Slovakia at 1 site in Slovakia.
Trial summary
TIP in the 1st line treatment of GCTs patients with unfavorable decline of serum tumor markers after 1 cycle of the BEP regimen.TIP will be administered to the patient until progression, unacceptable toxicity, complete response or inability of the subject to comply with study requirements. Read more about this study
- Who is it for?
- Ages 18 years and older, men only
- Conditions the study is for
- Germ Cell Tumor
- What is being tested?
- Paclitaxel, Ifosfamide and Cisplatin
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 19 participants
- Where
- 1 siteSlovakia
- Study dates
- Apr 2015to Jun 2020
- 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
- Patients older than 16 years.
- Evidence of NSGCT based on histologic examination or based on clinical evidence and high serum HCG or AFP levels (in case of clinical emergency, therapy can be started before pathologic sample is obtained if tumor markers are very elevated)
- Testicular, retroperitoneal, or mediastinal primary site.
- Evidence of disseminated disease (clinical stages II or III).
- 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.
- No prior chemotherapy.
- No previous carcinoma, except basal-cell carcinoma of the skin.
- Adequate renal function: measured or calculated creatinine clearance> 60 ml/min.
- Absolute granulocyte count >= 1,500/mm3, platelets >= 100,000 mm3, bilirubine <= 1.5 fold the upper normal value.
- Unfavorable tumor marker decline after 1.cycle of BEP
- Signed informed consent.
Who cannot join
- Patients infected by the Human Immunodeficiency Virus (HIV).
- Patients who do not fit inclusion criteria.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Treatment Strategy of the Use of 1st Line Chemotherapy in Patients With Poor-Prognosis Disseminated Non-Seminomatous Germ Cell Tumors Based on Tumor Marker Decline: A Phase II Trial of Paclitaxel, Ifosfamid and Cisplatin Regimen.
TIP in the 1st line treatment of GCTs patients with unfavorable decline of serum tumor markers after 1 cycle of the BEP regimen.TIP will be administered to the patient until progression, unacceptable toxicity, complete response or inability of the subject to comply with study requirements.
Read the detailed description
Cycle 1: BEP regimen
Serum tumor markers at day 18-21:
•Patients with an unfavorable pattern of tumor marker decrease after 1 cycle of BEP will receive 4 more cycles of TIP.
TIP regimen:
- Taxol 250 mg/ m2 iv on day 1
- Ifosfamid 1,2 g/ m2/ day iv x 5 days
- Cisplatin 20 mg/ m2/ day iv x 5 days One cycle of therapy consists of 22 days. Estimated duration of treatment: Until progression, unacceptable toxicity, complete response or inability of the subject to comply with study requirements.
- Conditions
- Germ Cell Tumor
- Being tested
- Paclitaxel, Ifosfamide, Cisplatin
- Keywords
- poor-prognosis germ cell cancer, paclitaxel, ifosfamid and cisplatin regimen, tumor marker decline
- Medical subject headings
- Neoplasms, Germ Cell and Embryonal
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PaclitaxelDrug
Also called paclitaxel ebewe
paclitaxel, ifosfamide, cisplatin until progression, unacceptable toxicity, complete response or inability of the subject to comply with study requirements
IfosfamideDrug
Also called ifosfamide-holoxan
paclitaxel, ifosfamide, cisplatin until progression, unacceptable toxicity, complete response or inability of the subject to comply with study requirements
CisplatinDrug
Also called cisplatin-hospira
paclitaxel, ifosfamide, cisplatin until progression, unacceptable toxicity, complete response or inability of the subject to comply with study requirements
| Study group | Role | What they receive |
|---|---|---|
| intravenous chemotherapy | Experimental | TIP regimen:
* Paclitaxel 250 mg/ m2 iv on day 1
* Ifosfamide 1,2 g/ m2/ day iv x 5 days
* Cisplatin 20 mg/ m2/ day iv x 5 days Receives: Drug: Paclitaxel; Drug: Ifosfamide; Drug: Cisplatin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Complete response rate
according RECIST criteria version 1.1
Measured: 36 month
Secondary outcomes (4)
Response rate
response rate after chemotherapy
Measured: 36 month
Progression-free survival
expressed as median and as 12-weeks post-treatment initiation continuous progression-free survival rate
Measured: 36 month
Number of adverse events grade III and IV
Measured: 36 month
overall survival
Survival will be estimated from the registration date to the date of last follow-up or death. Patients will be followed at least 3 years.
Measured: 36 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Apr 2015 (estimated)
- Study startApr 2015
- Primary completionJun 2020
- Study completionJun 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Germ Cell TumorStudies 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 19 participants (actual)
Sponsor and investigators
- Lead sponsor
- National Cancer Institute, Slovakia
- Sponsor type
- Other government
- Responsible party
- Sponsor
- Investigators
- Michal Mego, Ass.prof, Study chair, National Cancer Institute, Slovakia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02414685
- Sponsor's protocol ID
- GCTSK003
- Acronym
- TIP
- Status last verified
- Aug 2020
- First submitted
- 8 Apr 2015
- Last updated
- 7 Aug 2020
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 7 Aug 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Treatment Strategy of the Use of 1st Line Chemotherapy in Patients With Poor-Prognosis Disseminated Non-Seminomatous Germ Cell Tumors Based on Tumor Marker Decline: A Phase II Trial of Paclitaxel, Ifosfamid and Cisplatin Regimen.
- ClinicalTrials.gov ID
- NCT02414685
- Acronym / sponsor ID
- TIP / GCTSK003
- Conditions
- Germ Cell Tumor
- Keywords
- poor-prognosis germ cell cancer, paclitaxel, ifosfamid and cisplatin regimen, tumor marker decline
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 19 participants (actual)
- Lead sponsor
- National Cancer Institute, SlovakiaOther government
- Study start
- Apr 2015
- Primary completion
- Jun 2020 (actual)
- Study completion
- Jun 2020 (actual)
- First posted
- 13 Apr 2015 (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.
TIP in the 1st line treatment of GCTs patients with unfavorable decline of serum tumor markers after 1 cycle of the BEP regimen.TIP will be administered to the patient until progression, unacceptable toxicity, complete response or inability of the subject to comply with study requirements.
Detailed description
Cycle 1: BEP regimen
Serum tumor markers at day 18-21:
•Patients with an unfavorable pattern of tumor marker decrease after 1 cycle of BEP will receive 4 more cycles of TIP.
TIP regimen:
- Taxol 250 mg/ m2 iv on day 1
- Ifosfamid 1,2 g/ m2/ day iv x 5 days
- Cisplatin 20 mg/ m2/ day iv x 5 days One cycle of therapy consists of 22 days. Estimated duration of treatment: Until progression, unacceptable toxicity, complete response or inability of the subject to comply with study requirements.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| intravenous chemotherapy | Experimental | Drug: Paclitaxel, Drug: Ifosfamide, Drug: CisplatinTIP regimen: * Paclitaxel 250 mg/ m2 iv on day 1 * Ifosfamide 1,2 g/ m2/ day iv x 5 days * Cisplatin 20 mg/ m2/ day iv x 5 days |
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (14 listed)
- Patients older than 16 years.
- Evidence of NSGCT based on histologic examination or based on clinical evidence and high serum HCG or AFP levels (in case of clinical emergency, therapy can be started before pathologic sample is obtained if tumor markers are very elevated)
- Testicular, retroperitoneal, or mediastinal primary site.
- Evidence of disseminated disease (clinical stages II or III).
- Disease classified as poor prognosis according to IGCCCG criteria:
Key exclusion criteria (2 listed)
- Patients infected by the Human Immunodeficiency Virus (HIV).
- Patients who do not fit inclusion criteria.
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 |
|---|---|---|
| PaclitaxelAlso: paclitaxel ebewepaclitaxel, ifosfamide, cisplatin until progression, unacceptable toxicity, complete response or inability of the subject to comply with study requirements | Drug | intravenous chemotherapy |
| IfosfamideAlso: ifosfamide-holoxanpaclitaxel, ifosfamide, cisplatin until progression, unacceptable toxicity, complete response or inability of the subject to comply with study requirements | Drug | intravenous chemotherapy |
| CisplatinAlso: cisplatin-hospirapaclitaxel, ifosfamide, cisplatin until progression, unacceptable toxicity, complete response or inability of the subject to comply with study requirements | Drug | intravenous chemotherapy |
Primary outcome
Complete response rate
Time frame: 36 month
according RECIST criteria version 1.1
4 secondary outcomes
Response rate
Time frame: 36 month
Progression-free survival
Time frame: 36 month
Number of adverse events grade III and IV
Time frame: 36 month
overall survival
Time frame: 36 months
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 7 Aug 2020.
- 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. This study is not recruiting at the moment.
Michal Mego, Ass.prof study chair
National Cancer Institute, Slovakia
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 Paclitaxel, Ifosfamide and Cisplatin in people with Germ Cell Tumor, run by National Cancer Institute, Slovakia at 1 site in Slovakia.
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 14 inclusion and 2 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 7 Aug 2020. 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 Slovakia. 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?
Complete response rate (time frame: 36 month). 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 7 Aug 2020.