Intracranial GerminomaPhase 2NCT02782754
Chemotherapy Plus Reduced Radiotherapy in Intracranial Germinoma
A Phase 2 study testing Carboplatin, Etoposide and Cyclophosphamide in people with Intracranial Germinoma, 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 germinoma treated with chemotherapy plus reduced radiotherapy. Read more about this study
- Who is it for?
- Ages 3 to 30 years
- Conditions the study is for
- Intracranial Germinoma
- 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
- 40 participants
- Where
- 1 siteSouth Korea
- Study dates
- Jan 2013to Dec 2017
- 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 germinoma
Who cannot join
- Elevated serum/cerebrospinal fluid alpha-feto protein
- Patients with organ dysfunction as follows (creatinine elevation, ejection fraction, liver function test > CTCAE grade 2)
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: Treatment of Intracranial Germinoma With Chemotherapy Prior to Reduced Dose and Volume of Radiotherapy
The purpose of this study is to evaluate the outcome of intracranial germinoma treated with chemotherapy plus reduced radiotherapy.
Read the detailed description
Treatment outcome of intracranial germinoma is excellent with radiotherapy/chemotherapy. However, late sequelae are unavoidable especially with craniospinal irradiation, and various efforts have been done to reduce the dose and extent of radiotherapy. In this study, chemotherapy and further reduced dose of radiotherapy will be used to minimize the late sequelae in the patients with intracranial germinoma.
- Conditions
- Intracranial Germinoma
- Being tested
- Carboplatin, Etoposide, Cyclophosphamide, Bleomycin, Reduced dose of radiotherapy
- Medical subject headings
- Germinoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CarboplatinDrug
EtoposideDrug
CyclophosphamideDrug
BleomycinDrug
Reduced dose of radiotherapyRadiation
| Study group | Role | What they receive |
|---|---|---|
| Intracranial germinoma | Experimental | 1. Four cycles of chemotherapy with carboplatin, etoposide, (+ bleomycin) and cyclophosphamide, etoposide, (+ bleomycin) regimen
2. Reduced dose of radiotherapy
* Without seeding: 18 Gy to ventricle + 12.6 Gy to primary site
* With seeding: craniospinal irradiation 18 Gy + 12.6 Gy to primary site Receives: Drug: Carboplatin; Drug: Etoposide; Drug: Cyclophosphamide; Drug: Bleomycin; Radiation: Reduced dose of radiotherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rate of late sequelae
Measured: Up to 5 years
Secondary outcomes (1)
Rate of event free survival
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 posted25 May 2016 (estimated)
- Study startJan 2013
- Primary completionDec 2017 (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 Intracranial GerminomaStudies 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
- 40 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
- NCT02782754
- Sponsor's protocol ID
- 2012-10-101
- Status last verified
- May 2016
- First submitted
- 23 May 2016
- Last updated
- 25 May 2016
- Results posted
- No
- Data monitoring committee
- No
Publications
Lee JW, Lim DH, Sung KW, Cho HW, Ju HY, Yoo KH, Koo HH, Kim JH, Suh YL, Shin HJ. Induction Chemotherapy Reduces Radiation Therapy Dose and Volume in the Treatment of Intracranial Germinoma: Results of the SMC-G13 Trial. Int J Radiat Oncol Biol Phys. 2020 Nov 1;108(3):649-656. doi: 10.1016/j.ijrobp.2020.05.051. Epub 2020 Jun 2.
PubMed 32502506
Study at a glance
From the registry record, last updated by the sponsor on 25 May 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Treatment of Intracranial Germinoma With Chemotherapy Prior to Reduced Dose and Volume of Radiotherapy
- ClinicalTrials.gov ID
- NCT02782754
- Acronym / sponsor ID
- 2012-10-101
- Conditions
- Intracranial Germinoma
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Samsung Medical CenterUniversity, hospital or other
- Study start
- Jan 2013
- Primary completion
- Dec 2017 (estimated)
- First posted
- 25 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 germinoma treated with chemotherapy plus reduced radiotherapy.
Detailed description
Treatment outcome of intracranial germinoma is excellent with radiotherapy/chemotherapy. However, late sequelae are unavoidable especially with craniospinal irradiation, and various efforts have been done to reduce the dose and extent of radiotherapy. In this study, chemotherapy and further reduced dose of radiotherapy will be used to minimize the late sequelae in the patients with intracranial germinoma.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Intracranial germinoma | Experimental | Drug: Carboplatin, Drug: Etoposide, Drug: Cyclophosphamide, Drug: Bleomycin, Radiation: Reduced dose of radiotherapy1. Four cycles of chemotherapy with carboplatin, etoposide, (+ bleomycin) and cyclophosphamide, etoposide, (+ bleomycin) regimen 2. Reduced dose of radiotherapy * Without seeding: 18 Gy to ventricle + 12.6 Gy to primary site * With seeding: craniospinal irradiation 18 Gy + 12.6 Gy to primary site |
Who may qualify
- Ages
- 3 to 30 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (1 listed)
- Patients with pathologically proven intracranial germinoma
Key exclusion criteria (2 listed)
- Elevated serum/cerebrospinal fluid alpha-feto protein
- Patients with organ dysfunction as follows (creatinine elevation, ejection fraction, liver function test > CTCAE grade 2)
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 germinoma |
| Etoposide | Drug | Intracranial germinoma |
| Cyclophosphamide | Drug | Intracranial germinoma |
| Bleomycin | Drug | Intracranial germinoma |
| Reduced dose of radiotherapy | Radiation | Intracranial germinoma |
Primary outcome
Rate of late sequelae
Time frame: Up to 5 years
1 secondary outcome
Rate of event free survival
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 25 May 2016.
- Derived from this study: PubMed 32502506Lee JW, Lim DH, Sung KW, Cho HW, Ju HY, Yoo KH, Koo HH, Kim JH, Suh YL, Shin HJ. Induction Chemotherapy Reduces Radiation Therapy Dose and Volume in the Treatment of Intracranial Germinoma: Results of the SMC-G13 Trial. Int J Radiat Oncol Biol Phys. 2020 Nov 1;108(3):649-656. doi: 10.1016/j.ijrobp.2020.05.051. Epub 2020 Jun 2.
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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.
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 Germinoma, 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 1 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 25 May 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 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 late sequelae (time frame: Up to 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 NCT02782754, 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 25 May 2016.