Childhood Germ Cell TumorPhase 3NCT00274950
Observation and/or Combination Chemotherapy After Surgery or Biopsy in Treating Young Patients With Extracranial Germ Cell Tumors
A Phase 3 study testing bleomycin sulfate, carboplatin and cisplatin in people with Childhood Germ Cell Tumor and Extragonadal Germ Cell Tumor, run by Children's Cancer and Leukaemia Group at 20 sites in 2 countries.
Trial summary
RATIONALE: Sometimes, after surgery, the tumor may not need additional treatment until it progresses. In this case, observation may be sufficient. Drugs used in chemotherapy work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Read more about this study
- Who is it for?
- Ages Up to 17 years
- Conditions the study is for
- Childhood Germ Cell Tumor, Extragonadal Germ Cell Tumor, Ovarian Cancer
- What is being tested?
- bleomycin sulfate, carboplatin and cisplatin
- Type of treatment
- Surgery or procedure
- How many people
- 105 participants
- Where
- 20 sitesin 2 countries
- Study dates
- May 2005to May 2010
- Phase
- Phase 3
- 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 Up to 17 years
- All sexes
- No healthy volunteers
- Child
DISEASE CHARACTERISTICS:
- Histologically* proven extracranial malignant germ cell tumor (GCT), including mature/immature teratoma, with or without elevated alpha-fetoprotein (AFP) or human chorionic gonadotropin (HCG) levels
- Newly diagnosed disease
- Patients with relapsed or progressive extracranial malignant GCT allowed if previously treated with carboplatin, etoposide, and bleomycin (JEB) chemotherapy
- Patients relapsing following JEB are eligible for the study relapse strategy NOTE: *Patients with unequivocally raised AFP/HCG whose risk of biopsy is felt to be high can be diagnosed by clinical grounds, imaging, and markers
- No intracranial GCTs
PATIENT CHARACTERISTICS:
- Neutrophil count ≥ 1,000/mm^3
- Platelet count ≥ 100,000/mm^3
- Bilirubin ≤ 2 times upper limit of normal (ULN)
- ALT ≤ 3 times ULN
- Not pregnant or nursing
PRIOR CONCURRENT THERAPY:
- See Disease Characteristics
- No prior chemotherapy other than JEB
Trial locations and contacts
20 sites in 2 countries.
20 sites in 2 countries
United Kingdom19 sites
Royal Aberdeen Children's Hospital
Aberdeen, Scotland, AB25 2ZG
Royal Belfast Hospital for Sick Children
Belfast, Northern Ireland, BT12 6BE
Birmingham Children's Hospital
Birmingham, England, B4 6NH
Institute of Child Health at University of Bristol
Bristol, England, BS2 8AE
Addenbrooke's Hospital
Cambridge, England, CB2 2QQ
Childrens Hospital for Wales
Cardiff, Wales, CF14 4XW
Royal Hospital for Sick Children
Edinburgh, Scotland, EH9 1LF
Royal Hospital for Sick Children
Glasgow, Scotland, G3 8SJ
Leeds Cancer Centre at St. James's University Hospital
Leeds, England, LS9 7TF
Leicester Royal Infirmary
Leicester, England, LE1 5WW
Royal Liverpool Children's Hospital, Alder Hey
Liverpool, England, L12 2AP
Royal London Hospital
London, England, E1 1BB
Great Ormond Street Hospital for Children
London, England, WC1N 3JH
Royal Manchester Children's Hospital
Manchester, England, M27 4HA
Sir James Spence Institute of Child Health at Royal Victoria Infirmary
Newcastle upon Tyne, England, NE1 4LP
Queen's Medical Centre
Nottingham, England, NG7 2UH
Children's Hospital - Sheffield
Sheffield, England, S10 2TH
Southampton General Hospital
Southampton, England, SO16 6YD
Royal Marsden - Surrey
Sutton, England, SM2 5PT
About this study
Official title: Protocol for the Treatment of Extracranial Germ Cell Tumours in Children and Adolescents (GC III)
RATIONALE: Sometimes, after surgery, the tumor may not need additional treatment until it progresses. In this case, observation may be sufficient. Drugs used in chemotherapy work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving more than one drug (combination chemotherapy) may kill more tumor cells. Giving combination chemotherapy after surgery may kill any remaining tumor cells.
PURPOSE: This phase III trial is studying how well observation and/or combination chemotherapy works after surgery or biopsy in treating young patients with extracranial germ cell tumors.
Read the detailed description
OBJECTIVES:
- Stratify and reduce treatment for pediatric patients with extracranial germ cell tumors while maintaining event-free survival.
- Treat newly diagnosed patients with extracranial germ cell tumors requiring chemotherapy with a carboplatin-based strategy.
- Develop a common strategy for the treatment of patients with recurrent or progressive extracranial germ cell tumors.
- Register all cases of mature and immature teratoma.
- Develop a common strategy for the management of immature and mature teratoma, including follow-up strategies to permit early detection of yolk sac recurrence.
OUTLINE: This is a multicenter study.
Patients who have not had prior biopsy or surgical resection undergo biopsy (if feasible) or surgical resection. Patients with mature or immature teratoma undergo observation. These patients who relapse (i.e., tumor regrowth) may undergo further surgical resection unless tumor markers are significantly elevated. If the tumor markers are significantly elevated, these patients proceed to JEB chemotherapy according to risk group. Patients with all other malignant germ cell tumors are assigned to 1 of 3 treatment groups according to risk.
- Low-risk group: Patients with normal tumor markers undergo observation. Patients with rising tumor markers only AND no imageable tumor proceed to treatment as in the intermediate-risk group. Patients with rising tumor markers AND/OR imageable tumor are considered to have relapsed and proceed to treatment as in the intermediate- or high-risk group.
- Intermediate-risk group: Patients receive JEB chemotherapy comprising etoposide IV over 4 hours on days 1-3, carboplatin IV over 1 hour on day 2, and bleomycin IV over 30 minutes on day 3. Treatment repeats every 21 days for 4 courses. Patients with residual tumors after completion of chemotherapy may undergo second-look surgery.
- High-risk group: Patients receive JEB chemotherapy as in the intermediate-risk group for 6 courses. Patients with residual tumors after completion of chemotherapy may undergo second-look surgery.
- Relapse therapy: Patients in the intermediate- or high-risk group who relapse after completion of JEB chemotherapy receive vinblastine IV on days 1 and 2, ifosfamide IV over 1 hour on days 1-5, and cisplatin IV on days 1-5. Treatment repeats every 21 days for 6 courses.
PROJECTED ACCRUAL: A total of 105 patients will be accrued for this study.
- Being tested
- bleomycin sulfate, carboplatin, cisplatin, etoposide, ifosfamide
- Keywords
- childhood extragonadal germ cell tumor, childhood malignant ovarian germ cell tumor, childhood malignant testicular germ cell tumor, recurrent childhood malignant germ cell tumor, childhood teratoma, childhood extracranial germ cell tumor
- Medical subject headings
- Ovarian Neoplasms, Ovarian Germ Cell Cancer, Testicular Neoplasms, Teratoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
bleomycin sulfateBiological
carboplatinDrug
cisplatinDrug
etoposideDrug
ifosfamideDrug
vinblastine sulfateDrug
adjuvant therapyProcedure or surgery
conventional surgeryProcedure or surgery
What is being measured
The primary outcome is the main question the study is designed to answer.
Event-free survival
Continuation of treatment
Development of common and follow-up strategies
Registration of all cases of mature and immature teratoma
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jan 2006 (estimated)
- Study startMay 2005
- Primary completionMay 2010 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Childhood 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 3
- Primary purpose
- Treatment
- Masking
- None (open label)
- Enrolment
- 105 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Children's Cancer and Leukaemia Group
- Sponsor type
- University, hospital or other
- Investigators
- Juliet Hale, MD, Principal investigator, Sir James Spence Institute of Child Health at Royal Victoria Infirmary
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00274950
- Sponsor's protocol ID
- CDR0000454553
- Other IDs
- CCLG-GC-2005-04, EUDRACT-2004-002503-33, EU-20584
- Status last verified
- Jun 2009
- First submitted
- 10 Jan 2006
- Last updated
- 17 Sep 2013
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Sep 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Protocol for the Treatment of Extracranial Germ Cell Tumours in Children and Adolescents (GC III)
- ClinicalTrials.gov ID
- NCT00274950
- Acronym / sponsor ID
- CDR0000454553
- Keywords
- childhood extragonadal germ cell tumor, childhood malignant ovarian germ cell tumor, childhood malignant testicular germ cell tumor, recurrent childhood malignant germ cell tumor, childhood teratoma, childhood extracranial germ cell tumor
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 105 participants (estimated)
- Lead sponsor
- Children's Cancer and Leukaemia GroupUniversity, hospital or other
- Study start
- May 2005
- Primary completion
- May 2010 (estimated)
- First posted
- 11 Jan 2006 (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.
RATIONALE: Sometimes, after surgery, the tumor may not need additional treatment until it progresses. In this case, observation may be sufficient. Drugs used in chemotherapy work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving more than one drug (combination chemotherapy) may kill more tumor cells. Giving combination chemotherapy after surgery may kill any remaining tumor cells.
PURPOSE: This phase III trial is studying how well observation and/or combination chemotherapy works after surgery or biopsy in treating young patients with extracranial germ cell tumors.
Detailed description
OBJECTIVES:
- Stratify and reduce treatment for pediatric patients with extracranial germ cell tumors while maintaining event-free survival.
- Treat newly diagnosed patients with extracranial germ cell tumors requiring chemotherapy with a carboplatin-based strategy.
- Develop a common strategy for the treatment of patients with recurrent or progressive extracranial germ cell tumors.
- Register all cases of mature and immature teratoma.
- Develop a common strategy for the management of immature and mature teratoma, including follow-up strategies to permit early detection of yolk sac recurrence.
OUTLINE: This is a multicenter study.
Patients who have not had prior biopsy or surgical resection undergo biopsy (if feasible) or surgical resection. Patients with mature or immature teratoma undergo observation. These patients who relapse (i.e., tumor regrowth) may undergo further surgical resection unless tumor markers are significantly elevated. If the tumor markers are significantly elevated, these patients proceed to JEB chemotherapy according to risk group. Patients with all other malignant germ cell tumors are assigned to 1 of 3 treatment groups according to risk.
- Low-risk group: Patients with normal tumor markers undergo observation. Patients with rising tumor markers only AND no imageable tumor proceed to treatment as in the intermediate-risk group. Patients with rising tumor markers AND/OR imageable tumor are considered to have relapsed and proceed to treatment as in the intermediate- or high-risk group.
- Intermediate-risk group: Patients receive JEB chemotherapy comprising etoposide IV over 4 hours on days 1-3, carboplatin IV over 1 hour on day 2, and bleomycin IV over 30 minutes on day 3. Treatment repeats every 21 days for 4 courses. Patients with residual tumors after completion of chemotherapy may undergo second-look surgery.
- High-risk group: Patients receive JEB chemotherapy as in the intermediate-risk group for 6 courses. Patients with residual tumors after completion of chemotherapy may undergo second-look surgery.
- Relapse therapy: Patients in the intermediate- or high-risk group who relapse after completion of JEB chemotherapy receive vinblastine IV on days 1 and 2, ifosfamide IV over 1 hour on days 1-5, and cisplatin IV on days 1-5. Treatment repeats every 21 days for 6 courses.
PROJECTED ACCRUAL: A total of 105 patients will be accrued for this study.
Study design
- Primary purpose
- Treatment
- Masking
- None (open label)
Who may qualify
- Ages
- Up to 17 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
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 |
|---|---|---|
| bleomycin sulfate | Biological | – |
| carboplatin | Drug | – |
| cisplatin | Drug | – |
| etoposide | Drug | – |
| ifosfamide | Drug | – |
| vinblastine sulfate | Drug | – |
| adjuvant therapy | Procedure or surgery | – |
| conventional surgery | Procedure or surgery | – |
Primary outcome
Event-free survival
Continuation of treatment
Development of common and follow-up strategies
Registration of all cases of mature and immature teratoma
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Sep 2013.
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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.
Juliet Hale, MD principal investigator
Sir James Spence Institute of Child Health at Royal Victoria Infirmary
20 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing bleomycin sulfate, carboplatin and cisplatin in people with Childhood Germ Cell Tumor and Extragonadal Germ Cell Tumor, run by Children's Cancer and Leukaemia Group at 20 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
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 17 Sep 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 20 sites in United Kingdom, Ireland. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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?
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?
Event-free survival. The study lists 4 primary outcomes in all. 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 17 Sep 2013.