Pediatric Germ Cell TumorPhase 2NCT05455918
Paclitaxel/Ifosfamide/Cisplatin Chemotherapy for High Risk Pediatric Germ Cell Tumor
A Phase 2 study testing TIP treatment (paclitaxel/ifosfamide/cisplatin) in people with Pediatric Germ Cell Tumor, run by Yonsei University at 1 site in South Korea.
Trial summary
Germ cell tumor has generally good prognosis, but high risk germ cell tumor has still very poor prognosis. There remains the need of further improvement with other chemotherapy strategy. Read more about this study
- Who is it for?
- Ages 1 year to 20 years, men only
- Conditions the study is for
- Pediatric Germ Cell Tumor
- What is being tested?
- TIP treatment (paclitaxel/ifosfamide/cisplatin)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 42 participants
- Where
- 1 siteSouth Korea
- Study dates
- 26 Jul 2020to Jun 2028
- Phase
- Phase 2
- 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 1 year to 20 years
- Men only
- No healthy volunteers
- Child, Adult
Who may be able to join
- Over 1 year old and less than 20 years old
- Pathologically or cytologically diagnosed germ cell tumor
- Germ cell tumor which has not been treated previously
- Higher than stage II (stage I should be excluded)
- Pathologic type
- embryonal carcinoma
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- choriocarcinoma
- yolk sac tumor
- teratoma with malignant germ cell tumor elements
- High risk definition
- More than 11 years old, male or female
- Less than 11 years old, male or female
- Extragonodal germ cell tumor, stage III
- Extragonodal germ cell tumor, stage IV
- Ovarian germ cell tumor, stage IV
- More than 8 weeks of life expectancy
- performance level : ECOG Performance score 0, 1, or 2
- informed consent should be obtained
Who cannot join
- pregnancy or lactating patients (fertile men or women should agree to avoid pregnancy during the trial period)
- previously reported allergy or hypersensitivity to trial chemotherapeutic agent
- severe hypersensitivity to the agent containing Cremophor R EL (polyoxyethylated castor oil)
- Acceptable organ functions
- Bone marrow : Absolute neutrophil count >=1000/µL , platelet >= 100000/µL
- Renal function : serum creatinine ≤ 1.5 x upper limit of normal (ULN)
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- Hepatic function : total bilirubin ≤ 1.5 x ULN, ALT ≤ 3.0 x UNL
- Cardiac Function : Ejection fraction ≥ 50%
- Uncontrolled infection
- Uncontrolled urinary obstruction
- Uncontrolled cystitis
- Followings will be excluded
- Mature teratoma
- Gliomatosis Peritonei
- Low Risk Germ Cell Tumor
- testicular stage I
- ovarian stage I
- recurrent, refractory tumor
- Concomitant other trial agent beside the agents in this trial
- Concomitant chemotherapeutic agents besides the agents in this trial
- Concomitant tumor other than germ cell tumor
- Other trial agents
- Other chemotherapeutic agents
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
South Korea1 site, 1 recruiting
- Recruiting
Yonsei University Health System, Severance Hospital
Seoul
Jung Woo Han, 82-2-2228-2050, JWHAN@yuhs.ac
About this study
Official title: Non-randomized, Phase II, Open-label Study for Efficacy and Safety of Consolidation Paclitaxel/Ifosfamide/Cisplatin (TIP) Chemotherapy for High Risk Pediatric Germ Cell Tumor
Germ cell tumor has generally good prognosis, but high risk germ cell tumor has still very poor prognosis. There remains the need of further improvement with other chemotherapy strategy. Especially more than 11 years old, mediastinal germ cell tumor, stage 3 or 4 extragonodal germ cell tumor or the remained tumor after the primary treatment are the group with the poorest prognosis.
Paclitaxel is widely used chemotherapeutic agent in adults and the experience of the agent has also been accumulated in children. The paclitaxel, ifosfamide, cisplatin (TIP) regimen has been used 2nd-line treatment for germ cell tumor and there is some promising result of the role of TIP in first line germ cell tumor treatment. In high risk pediatric germ cell tumor patients, TIP regimen will be able to reduce lung toxicity from the bleomycin as the standard regimen and to improve the survival. In this trial, the efficacy and safety of TIP as the first line treatment for germ cell tumor will be elucidated.
- Conditions
- Pediatric Germ Cell Tumor
- Being tested
- TIP treatment (paclitaxel/ifosfamide/cisplatin)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TIP treatment (paclitaxel/ifosfamide/cisplatin)Drug
Paclitaxel 240mg/m2/day D1 (total 240mg/m2) Ifosfamide 1.5g/m2/day D2~5 (total 6g/m2) Cisplatin 25mg/m2/day D2~5 (total 100mg/m2)
| Study group | Role | What they receive |
|---|---|---|
| TIP treatment arm | Experimental | Not described Receives: Drug: TIP treatment (paclitaxel/ifosfamide/cisplatin) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Complete Response Rate
Measured: 12weeks
Secondary outcomes (4)
Overall Response Rate
Measured: 12 weeks and 18 weeks
Complete Response Rate
Measured: 18 weeks
Overall Survival
Measured: 3 years
Event Free Survival
Measured: 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jul 2022
- Study start26 Jul 2020
- Primary completionJun 2025 (estimated)
- Study completionJun 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pediatric Germ Cell TumorStudies of the same condition, open and under way.
- More trials run by Yonsei UniversityThe 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
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 42 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Yonsei University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jung Woo Han, Principal investigator, Department of Pediatric Hematology and Oncology, Yonsei Cancer Center, Yonsei University Health System.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05455918
- Sponsor's protocol ID
- 4-2020-0658
- Status last verified
- Jul 2022
- First submitted
- 8 Jul 2022
- Last updated
- 13 Jul 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Jul 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Non-randomized, Phase II, Open-label Study for Efficacy and Safety of Consolidation Paclitaxel/Ifosfamide/Cisplatin (TIP) Chemotherapy for High Risk Pediatric Germ Cell Tumor
- ClinicalTrials.gov ID
- NCT05455918
- Acronym / sponsor ID
- 4-2020-0658
- Conditions
- Pediatric Germ Cell Tumor
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 42 participants (estimated)
- Lead sponsor
- Yonsei UniversityUniversity, hospital or other
- Study start
- 26 Jul 2020 (actual)
- Primary completion
- Jun 2025 (estimated)
- Study completion
- Jun 2028 (estimated)
- First posted
- 13 Jul 2022 (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.
Germ cell tumor has generally good prognosis, but high risk germ cell tumor has still very poor prognosis. There remains the need of further improvement with other chemotherapy strategy. Especially more than 11 years old, mediastinal germ cell tumor, stage 3 or 4 extragonodal germ cell tumor or the remained tumor after the primary treatment are the group with the poorest prognosis.
Paclitaxel is widely used chemotherapeutic agent in adults and the experience of the agent has also been accumulated in children. The paclitaxel, ifosfamide, cisplatin (TIP) regimen has been used 2nd-line treatment for germ cell tumor and there is some promising result of the role of TIP in first line germ cell tumor treatment. In high risk pediatric germ cell tumor patients, TIP regimen will be able to reduce lung toxicity from the bleomycin as the standard regimen and to improve the survival. In this trial, the efficacy and safety of TIP as the first line treatment for germ cell tumor will be elucidated.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| TIP treatment arm | Experimental | Drug: TIP treatment (paclitaxel/ifosfamide/cisplatin) |
Who may qualify
- Ages
- 1 year to 20 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (18 listed)
- Over 1 year old and less than 20 years old
- Pathologically or cytologically diagnosed germ cell tumor
- Germ cell tumor which has not been treated previously
- Higher than stage II (stage I should be excluded)
- Pathologic type
Key exclusion criteria (23 listed)
- pregnancy or lactating patients (fertile men or women should agree to avoid pregnancy during the trial period)
- previously reported allergy or hypersensitivity to trial chemotherapeutic agent
- severe hypersensitivity to the agent containing Cremophor R EL (polyoxyethylated castor oil)
- Acceptable organ functions
- Followings will be excluded
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 |
|---|---|---|
| TIP treatment (paclitaxel/ifosfamide/cisplatin)Paclitaxel 240mg/m2/day D1 (total 240mg/m2) Ifosfamide 1.5g/m2/day D2~5 (total 6g/m2) Cisplatin 25mg/m2/day D2~5 (total 100mg/m2) | Drug | TIP treatment arm |
Primary outcome
Complete Response Rate
Time frame: 12weeks
4 secondary outcomes
Overall Response Rate
Time frame: 12 weeks and 18 weeks
Complete Response Rate
Time frame: 18 weeks
Overall Survival
Time frame: 3 years
Event Free Survival
Time frame: 3 years
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 13 Jul 2022.
- Individual participant dataSharing planned: No
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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.
Jung Woo Han principal investigator
Department of Pediatric Hematology and Oncology, Yonsei Cancer Center, Yonsei University Health System.
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 TIP treatment (paclitaxel/ifosfamide/cisplatin) in people with Pediatric Germ Cell Tumor, run by Yonsei University at 1 site in South Korea.
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 23 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 13 Jul 2022. 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 South Korea. 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?
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 Jung Woo Han (82-2-2228-2050, JWHAN@yuhs.ac), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Complete Response Rate (time frame: 12weeks). 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 13 Jul 2022.