NeuroblastomaNCT00287950
Combination Chemotherapy, Surgery, and Radiation Therapy in Treating Infants With Neuroblastoma
A study testing carboplatin, cisplatin and cyclophosphamide in people with Neuroblastoma, run by Children's Cancer and Leukaemia Group at 22 sites in 2 countries.
Trial summary
RATIONALE: 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. Radiation therapy uses high-energy x-rays to kill tumor cells. Read more about this study
- Who is it for?
- Ages Up to 1 year
- Conditions the study is for
- Neuroblastoma
- What is being tested?
- carboplatin, cisplatin and cyclophosphamide
- Type of treatment
- Surgery or procedure
- How many people
- 120 participants
- Where
- 22 sitesin 2 countries
- Study dates
- Sep 1992to not given
- Phase
- Interventional
- 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 1 year
- All sexes
- No healthy volunteers
- Child
DISEASE CHARACTERISTICS:
- Histologically or cytologically confirmed newly diagnosed neuroblastoma
- Any stage disease
- No previously treated disease
- Must be diagnosed before the first birthday
- Must be able to start treatment before reaching 13 months of age
PATIENT CHARACTERISTICS:
- Not specified
PRIOR CONCURRENT THERAPY:
- Not specified
Trial locations and contacts
22 sites in 2 countries.
22 sites in 2 countries
United Kingdom21 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 at Cambridge University Hospitals NHS Foundation Trust
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 NHS Trust
London, England, WC1N 3JH
Meyerstein Institute of Oncology at University College of London Hospitals
London, England, WIT 3AA
Central Manchester and Manchester Children's University Hospitals NHS Trust
Manchester, England, M27 4HA
Sir James Spence Institute of Child Health
Newcastle upon Tyne, England, NE1 4LP
Queen's Medical Centre
Nottingham, England, NG7 2UH
Oxford Radcliffe Hospital
Oxford, England, 0X3 9DU
Children's Hospital - Sheffield
Sheffield, England, S10 2TH
Southampton General Hospital
Southampton, England, SO16 6YD
Royal Marsden NHS Foundation Trust - Surrey
Sutton, England, SM2 5PT
About this study
Official title: Protocol for Infants With Neuroblastoma Diagnosed Under the Age of One Year
RATIONALE: 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. Radiation therapy uses high-energy x-rays to kill tumor cells. Giving combination chemotherapy before surgery may make the tumor smaller and reduce the amount of normal tissue that needs to be removed. Giving chemotherapy and radiation therapy after surgery may kill any tumor cells that remain after surgery. Sometimes, the tumor may not need any treatment until it progresses. In this case, observation may be sufficient.
PURPOSE: This clinical trial is studying how well giving combination chemotherapy together with surgery and radiation therapy works in treating infants with neuroblastoma.
Read the detailed description
OBJECTIVES:
- Register all children < 12 months of age diagnosed with neuroblastoma.
- Evaluate possible prognostic factors in these patients with particular reference to the collection of biological material.
- Correlate outcome with factors other than stage in these patients.
- Determine criteria to modify treatment for some children with advanced disease without impairing survival.
OUTLINE: This is a nonrandomized, multicenter study. Patients are assigned to 1 of 4 treatment groups according to disease stage.
- Group 1 (stage 1, 2A, or 2B disease): Patients undergo surgical resection of the tumor. Patients with paraspinal tumors may receive chemotherapy* to shrink the tumor before undergoing surgery. Patients with local recurrence after surgery proceed to treatment as in group 3. Patients with metastatic recurrence after surgery proceed to treatment as in group 4.
- Group 2 (stage 4S disease): Patients undergo observation only. Patients with hepatomegaly or progressive disease may receive chemotherapy*. Patients who do not respond to chemotherapy may undergo up to 4 courses of radiotherapy.
- Group 3 (stage 3 disease): Patients receive OPEC chemotherapy comprising vincristine IV and cyclophosphamide IV on day 1, cisplatin IV continuously over 24 hours on day 1, and etoposide IV over 4 hours on day 3 during courses 1, 3, and 5. Patients receive OJEC chemotherapy comprising vincristine IV, cyclophosphamide IV, etoposide IV over 4 hours, and carboplatin IV over 1 hour on day 1 during courses 2, 4, and 6. Courses repeat every 3 weeks with alternating OPEC and OJEC chemotherapy for 6 courses. Patients with residual disease then receive 4 additional courses of alternating OPEC and OJEC chemotherapy. Patients whose tumor becomes resectable after either 6 or 10 courses of chemotherapy undergo surgery. Patients with residual disease after 10 courses of chemotherapy are assessed by regular scans. Patients with disease progression on scans undergo radiotherapy. Patients with ganglioneuroma or total necrosis only with no evidence of neuroblastoma after either 6 or 10 courses of chemotherapy receive no further treatment.
- Group 4 (stage 4 disease): Patients receive alternating courses of OPEC and OJEC for 6 courses as in group 3. Patients who do not achieve metastatic complete response (CR) receive 4 additional courses of alternating OPEC and OJEC chemotherapy. Patients achieving metastatic CR after either 6 or 10 courses of chemotherapy undergo surgery to remove the tumor. Patients with macroscopic residual disease on resected specimen receive 4 additional courses of alternating OPEC and OJEC chemotherapy and then undergo biopsy. Patients with residual disease on biopsy are assessed by regular scans. Patients with disease progression on scans undergo radiotherapy. Patients with ganglioneuroma or total necrosis only after surgery with or without the 4 additional courses of chemotherapy receive no further treatment.
NOTE: * OJEC chemotherapy with a lower dose of carboplatin
After completion of study treatment, patients are followed periodically.
PROJECTED ACCRUAL: A total of 120 patients will be accrued for this study.
- Conditions
- Neuroblastoma
- Being tested
- carboplatin, cisplatin, cyclophosphamide, etoposide, vincristine sulfate
- Keywords
- disseminated neuroblastoma, localized resectable neuroblastoma, localized unresectable neuroblastoma, regional neuroblastoma, stage 4S neuroblastoma
- Medical subject headings
- Neuroblastoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
carboplatinDrug
cisplatinDrug
cyclophosphamideDrug
etoposideDrug
adjuvant therapyProcedure or surgery
conventional surgeryProcedure or surgery
neoadjuvant therapyProcedure or surgery
radiation therapyRadiation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Feb 2006 (estimated)
- Study startSep 1992
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for NeuroblastomaStudies 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 N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Masking
- None (open label)
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Children's Cancer and Leukaemia Group
- Sponsor type
- University, hospital or other
- Investigators
- Penelope Brock, MD, PhD, Study chair, University College London HospitalsMary P. Gerrard, MBChB, FRCP, FRCPCH, Children's Hospital - SheffieldAndrew David J. Pearson, MD, FRCP, DCh, University of Newcastle Upon-TyneS. J. Keith Holmes, DO, St. George's HospitalAnn Barrett, University of Glasgow
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00287950
- Sponsor's protocol ID
- CDR0000454726
- Other IDs
- CCLG-1992-05, EU-20593, CCLG-9205
- Status last verified
- Dec 2006
- First submitted
- 6 Feb 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 Infants With Neuroblastoma Diagnosed Under the Age of One Year
- ClinicalTrials.gov ID
- NCT00287950
- Acronym / sponsor ID
- CDR0000454726
- Conditions
- Neuroblastoma
- Keywords
- disseminated neuroblastoma, localized resectable neuroblastoma, localized unresectable neuroblastoma, regional neuroblastoma, stage 4S neuroblastoma
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- Children's Cancer and Leukaemia GroupUniversity, hospital or other
- Study start
- Sep 1992
- First posted
- 7 Feb 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: 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. Radiation therapy uses high-energy x-rays to kill tumor cells. Giving combination chemotherapy before surgery may make the tumor smaller and reduce the amount of normal tissue that needs to be removed. Giving chemotherapy and radiation therapy after surgery may kill any tumor cells that remain after surgery. Sometimes, the tumor may not need any treatment until it progresses. In this case, observation may be sufficient.
PURPOSE: This clinical trial is studying how well giving combination chemotherapy together with surgery and radiation therapy works in treating infants with neuroblastoma.
Detailed description
OBJECTIVES:
- Register all children < 12 months of age diagnosed with neuroblastoma.
- Evaluate possible prognostic factors in these patients with particular reference to the collection of biological material.
- Correlate outcome with factors other than stage in these patients.
- Determine criteria to modify treatment for some children with advanced disease without impairing survival.
OUTLINE: This is a nonrandomized, multicenter study. Patients are assigned to 1 of 4 treatment groups according to disease stage.
- Group 1 (stage 1, 2A, or 2B disease): Patients undergo surgical resection of the tumor. Patients with paraspinal tumors may receive chemotherapy* to shrink the tumor before undergoing surgery. Patients with local recurrence after surgery proceed to treatment as in group 3. Patients with metastatic recurrence after surgery proceed to treatment as in group 4.
- Group 2 (stage 4S disease): Patients undergo observation only. Patients with hepatomegaly or progressive disease may receive chemotherapy*. Patients who do not respond to chemotherapy may undergo up to 4 courses of radiotherapy.
- Group 3 (stage 3 disease): Patients receive OPEC chemotherapy comprising vincristine IV and cyclophosphamide IV on day 1, cisplatin IV continuously over 24 hours on day 1, and etoposide IV over 4 hours on day 3 during courses 1, 3, and 5. Patients receive OJEC chemotherapy comprising vincristine IV, cyclophosphamide IV, etoposide IV over 4 hours, and carboplatin IV over 1 hour on day 1 during courses 2, 4, and 6. Courses repeat every 3 weeks with alternating OPEC and OJEC chemotherapy for 6 courses. Patients with residual disease then receive 4 additional courses of alternating OPEC and OJEC chemotherapy. Patients whose tumor becomes resectable after either 6 or 10 courses of chemotherapy undergo surgery. Patients with residual disease after 10 courses of chemotherapy are assessed by regular scans. Patients with disease progression on scans undergo radiotherapy. Patients with ganglioneuroma or total necrosis only with no evidence of neuroblastoma after either 6 or 10 courses of chemotherapy receive no further treatment.
- Group 4 (stage 4 disease): Patients receive alternating courses of OPEC and OJEC for 6 courses as in group 3. Patients who do not achieve metastatic complete response (CR) receive 4 additional courses of alternating OPEC and OJEC chemotherapy. Patients achieving metastatic CR after either 6 or 10 courses of chemotherapy undergo surgery to remove the tumor. Patients with macroscopic residual disease on resected specimen receive 4 additional courses of alternating OPEC and OJEC chemotherapy and then undergo biopsy. Patients with residual disease on biopsy are assessed by regular scans. Patients with disease progression on scans undergo radiotherapy. Patients with ganglioneuroma or total necrosis only after surgery with or without the 4 additional courses of chemotherapy receive no further treatment.
NOTE: * OJEC chemotherapy with a lower dose of carboplatin
After completion of study treatment, patients are followed periodically.
PROJECTED ACCRUAL: A total of 120 patients will be accrued for this study.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Masking
- None (open label)
Who may qualify
- Ages
- Up to 1 year
- 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 |
|---|---|---|
| carboplatin | Drug | – |
| cisplatin | Drug | – |
| cyclophosphamide | Drug | – |
| etoposide | Drug | – |
| vincristine sulfate | Drug | – |
| adjuvant therapy | Procedure or surgery | – |
| conventional surgery | Procedure or surgery | – |
| neoadjuvant therapy | Procedure or surgery | – |
| radiation therapy | Radiation | – |
Primary outcome
Not reported in the source record.
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.
Penelope Brock, MD, PhD study chair
University College London Hospitals
Mary P. Gerrard, MBChB, FRCP, FRCPCH
Children's Hospital - Sheffield
Andrew David J. Pearson, MD, FRCP, DCh
University of Newcastle Upon-Tyne
22 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing carboplatin, cisplatin and cyclophosphamide in people with Neuroblastoma, run by Children's Cancer and Leukaemia Group at 22 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 22 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.
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.
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.