Intracranial Non-germinomatous Germ Cell TumorPhase 2NCT02784054
Reduced Dose Radiotherapy Following High Dose Chemotherapy in Intracranial Non-germinomatous Germ Cell Tumor
A Phase 2 study testing Carboplatin, Etoposide and Cyclophosphamide in people with Intracranial Non-germinomatous Germ Cell Tumor, run by Samsung Medical Center at 1 site in South Korea.
Trial summary
The purpose of this study is to evaluate the outcome of intracranial non-germinomatous germ cell tumor (NGGCT) treated with reduced radiotherapy following high dose chemotherapy and autologous stem cell transplantation (HDCT/auto-SCT). Read more about this study
- Who is it for?
- Ages 3 to 30 years
- Conditions the study is for
- Intracranial Non-germinomatous Germ Cell Tumor
- What is being tested?
- Carboplatin, Etoposide and Cyclophosphamide
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 25 participants
- Where
- 1 siteSouth Korea
- Study dates
- Apr 2014to Mar 2023
- 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 3 to 30 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Patients with pathologically proven intracranial non-germinomatous germ cell tumor or
- Patients who have brain mass which are suspected as intracranial germ cell tumor and elevated serum or cerebrospinal fluid alpha-feto protein.
Who cannot join
- Patients with organ dysfunction (ejection fraction <40%, creatinine > 3 x upper limit of normal (ULN), aspartate aminotransferase/alanine aminotransaminase > 5 x ULN).
- Pregnant or nursing women
Trial locations and contacts
1 site in 1 country.
South Korea1 site, 1 recruiting
- Recruiting
Samsung Medical Center
Seoul
Ki Woong Sung, 82-2-3410-3529, kwsped@skku.edu
Ki Woong Sung
About this study
Official title: Reduced-dose Radiotherapy Following High-dose Chemotherapy and Autologous Stem Cell Transplantation in Patients With Central Nervous System Non-germinomatous Germ Cell Tumors
The purpose of this study is to evaluate the outcome of intracranial non-germinomatous germ cell tumor (NGGCT) treated with reduced radiotherapy following high dose chemotherapy and autologous stem cell transplantation (HDCT/auto-SCT).
Read the detailed description
Treatment outcome of intracranial NGGCT is around 50% with conventional chemo- and radiotherapy. Also, late sequelae such as endocrinopathy or cognitive problem are unavoidable especially with craniospinal irradiation. In this study, high dose chemotherapy and reduced dose of radiotherapy will be used to improve survival and minimize the late sequelae in the patients with intracranial NGGCT.
- Being tested
- Carboplatin, Etoposide, Cyclophosphamide, Bleomycin, Thiotepa
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CarboplatinDrug
EtoposideDrug
CyclophosphamideDrug
BleomycinDrug
ThiotepaDrug
MelphalanDrug
Reduced dose radiotherapyRadiation
| Study group | Role | What they receive |
|---|---|---|
| Intracranial NGGCT | Experimental | 1. Six cycles of chemotherapy with carboplatin, etoposide, bleomycin (CEB) and cyclophosphamide, etoposide, bleomycin (CyEB) regimen.
2. Peripheral blood stem cell collection during the first cycle of chemotherapy.
3. Surgery, if there is residual tumor after chemotherapy.
4. Tandem high dose chemotherapy (HDCT) and autologous stem cell transplantation (auto-SCT)
* 1st HDCT: Carboplatin, thiotepa, etoposide
* 2nd HDCT: Cyclophosphamide, melphalan
5. Reduced dose of radiotherapy Receives: Drug: Carboplatin; Drug: Etoposide; Drug: Cyclophosphamide; Drug: Bleomycin; Drug: Thiotepa; Drug: Melphalan; Radiation: Reduced dose radiotherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rate of event free survival
Measured: Up to 3 years
Secondary outcomes (1)
Rate of late adverse events
Measured: 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 May 2016 (estimated)
- Study startApr 2014
- Primary completionMar 2021 (estimated)
- Study completionMar 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Intracranial Non-germinomatous Germ Cell TumorStudies of the same condition, open and under way.
- More trials run by Samsung Medical CenterThe 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
- 25 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Samsung Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02784054
- Sponsor's protocol ID
- 2013-07-146
- Status last verified
- Mar 2020
- First submitted
- 24 May 2016
- Last updated
- 19 Mar 2020
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Mar 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Reduced-dose Radiotherapy Following High-dose Chemotherapy and Autologous Stem Cell Transplantation in Patients With Central Nervous System Non-germinomatous Germ Cell Tumors
- ClinicalTrials.gov ID
- NCT02784054
- Acronym / sponsor ID
- 2013-07-146
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 25 participants (estimated)
- Lead sponsor
- Samsung Medical CenterUniversity, hospital or other
- Study start
- Apr 2014
- Primary completion
- Mar 2021 (estimated)
- Study completion
- Mar 2023 (estimated)
- First posted
- 26 May 2016 (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 evaluate the outcome of intracranial non-germinomatous germ cell tumor (NGGCT) treated with reduced radiotherapy following high dose chemotherapy and autologous stem cell transplantation (HDCT/auto-SCT).
Detailed description
Treatment outcome of intracranial NGGCT is around 50% with conventional chemo- and radiotherapy. Also, late sequelae such as endocrinopathy or cognitive problem are unavoidable especially with craniospinal irradiation. In this study, high dose chemotherapy and reduced dose of radiotherapy will be used to improve survival and minimize the late sequelae in the patients with intracranial NGGCT.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Intracranial NGGCT | Experimental | Drug: Carboplatin, Drug: Etoposide, Drug: Cyclophosphamide, Drug: Bleomycin, Drug: Thiotepa, Drug: Melphalan, Radiation: Reduced dose radiotherapy1. Six cycles of chemotherapy with carboplatin, etoposide, bleomycin (CEB) and cyclophosphamide, etoposide, bleomycin (CyEB) regimen. 2. Peripheral blood stem cell collection during the first cycle of chemotherapy. 3. Surgery, if there is residual tumor after chemotherapy. 4. Tandem high dose chemotherapy (HDCT) and autologous stem cell transplantation (auto-SCT) * 1st HDCT: Carboplatin, thiotepa, etoposide * 2nd HDCT: Cyclophosphamide, melphalan 5. Reduced dose of radiotherapy |
Who may qualify
- Ages
- 3 to 30 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (2 listed)
- Patients with pathologically proven intracranial non-germinomatous germ cell tumor or
- Patients who have brain mass which are suspected as intracranial germ cell tumor and elevated serum or cerebrospinal fluid alpha-feto protein.
Key exclusion criteria (2 listed)
- Patients with organ dysfunction (ejection fraction <40%, creatinine > 3 x upper limit of normal (ULN), aspartate aminotransferase/alanine aminotransaminase > 5 x ULN).
- Pregnant or nursing women
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 | Drug | Intracranial NGGCT |
| Etoposide | Drug | Intracranial NGGCT |
| Cyclophosphamide | Drug | Intracranial NGGCT |
| Bleomycin | Drug | Intracranial NGGCT |
| Thiotepa | Drug | Intracranial NGGCT |
| Melphalan | Drug | Intracranial NGGCT |
| Reduced dose radiotherapy | Radiation | Intracranial NGGCT |
Primary outcome
Rate of event free survival
Time frame: Up to 3 years
1 secondary outcome
Rate of late adverse events
Time frame: 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 19 Mar 2020.
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.
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 Cyclophosphamide in people with Intracranial Non-germinomatous Germ Cell Tumor, run by Samsung Medical Center 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 2 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: status not confirmed, as of the sponsor's last update on 19 Mar 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 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Ki Woong Sung, MD, PhD (82-2-3410-3529, kiwoong.sung@samsung.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Rate of event free survival (time frame: Up to 3 years). 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 19 Mar 2020.