Comparison of Radiation Therapy Regimens in Combination With Chemotherapy in Treating Young Patients With Newly Diagnosed Standard-Risk Medulloblastoma
This study is currently recruiting participants.
Verified November 2012 by National Cancer Institute (NCI)
Sponsor:
Children's Oncology Group
Collaborator:
Information provided by:
National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:
NCT00085735
First received: June 14, 2004
Last updated: November 22, 2012
Last verified: November 2012
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Purpose
RATIONALE: Radiation therapy uses high-energy x-rays to damage tumor cells. Drugs used in chemotherapy, such as vincristine, cisplatin, lomustine, and cyclophosphamide, work in different ways to stop tumor cells from dividing so they stop growing or die. Giving radiation therapy with chemotherapy after surgery may kill any remaining tumor cells. It is not yet known whether standard-dose radiation therapy combined with chemotherapy after surgery is more effective than reduced-dose craniospinal (head and spine) radiation therapy plus either posterior fossa (back of the brain) boost or tumor bed (site of the tumor) boost radiation therapy combined with chemotherapy in treating medulloblastoma.
PURPOSE: This randomized phase III trial is studying standard-dose radiation therapy to see how well it works compared to reduced-dose craniospinal radiation therapy AND posterior fossa boost radiation therapy to see how well it works compared to tumor bed boost radiation therapy when given together with chemotherapy in treating young patients who have undergone surgery for newly diagnosed standard-risk medulloblastoma.
| Condition | Intervention | Phase |
|---|---|---|
|
Brain and Central Nervous System Tumors |
Drug: cisplatin Drug: cyclophosphamide Drug: lomustine Drug: vincristine sulfate Radiation: radiation therapy |
Phase 3 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Primary Purpose: Treatment |
| Official Title: | A Study Evaluating Limited Target Volume Boost Irradiation and Reduced Dose Craniospinal Radiotherapy (18.00 Gy) and Chemotherapy in Children With Newly Diagnosed Standard Risk Medulloblastoma: A Phase III Double Randomized Trial |
Resource links provided by NLM:
Further study details as provided by National Cancer Institute (NCI):
Primary Outcome Measures:
- Time to event as measured by the time to disease progression, disease recurrence, death from any cause, or occurrence of a second malignant neoplasm at 3 years [ Designated as safety issue: No ]
Secondary Outcome Measures:
- Time to recurrence, progression, or death due to cancer at 3 years [ Designated as safety issue: No ]
- Time to death at 3 years [ Designated as safety issue: No ]
- Local Posterior Fossa (LPF) Failure as determined by tumor recurrence or progression within the tumor bed at 3 years [ Designated as safety issue: No ]
- Non-local Posterior Fossa (NLPF) Failure as determined by recurrence outside CTVboost but within CTVPF at 3 years [ Designated as safety issue: No ]
- Non-Posterior Fossa (NPF) Failure as determine by recurrence within the neuroaxis but outside of CTVPF at 3 years [ Designated as safety issue: No ]
- Post-treatment neurocognitive function as measured by Neuropsychometric battery at 3 years [ Designated as safety issue: No ]
- Post-treatment hearing loss as measure by Audiogram or brainstem auditory evoked response (BAER) at 3 years [ Designated as safety issue: No ]
- Post-treatment endocrine function (e.g., growth, sexual maturation, and need for hormone replacement) by laboratory assesment, clinical history, and exam at 3 years [ Designated as safety issue: No ]
- Quality of Life as measured by Pediatric Quality of Life Inventory (PedsQL), Behavior Assessment System for Children (BASC), Behavior Rating Inventory of Executive Function (BRIEF), and Adaptive Behavior Assessment System (ABAS) at 3 years [ Designated as safety issue: No ]
| Estimated Enrollment: | 510 |
| Study Start Date: | April 2004 |
| Estimated Primary Completion Date: | July 2016 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: Arm I
Patients undergo reduced-dose craniospinal radiotherapy with boost.
|
Radiation: radiation therapy
Given on days 1-5, 8-12, 15-19, 22-26, 29-33, 36-40, and 43-47 (weeks 0-6) at different doses.
|
|
Active Comparator: Arm II
Patients undergo standard-dose craniospinal radiotherapy with boost.
|
Radiation: radiation therapy
Given on days 1-5, 8-12, 15-19, 22-26, 29-33, 36-40, and 43-47 (weeks 0-6) at different doses.
|
|
Active Comparator: Arm III
Patients will undergo radiotherapy boost to the entire posterior fossa.
|
Radiation: radiation therapy
Given on days 1-5, 8-12, 15-19, 22-26, 29-33, 36-40, and 43-47 (weeks 0-6) at different doses.
|
|
Experimental: Arm IV
Patients will undergo radiotherapy boost to the tumor bed only.
|
Radiation: radiation therapy
Given on days 1-5, 8-12, 15-19, 22-26, 29-33, 36-40, and 43-47 (weeks 0-6) at different doses.
|
|
Experimental: Regimen A (courses 1, 2, 4, 5, 7, and 8)
Patients receive oral lomustine and cisplatin IV over 6 hours on day 1 and vincristine IV on days 1, 8, and 15 of weeks 11, 17, 27, 33, 43, and 49.
|
Drug: cisplatin
Given IV
Drug: lomustine
Given orally
Drug: vincristine sulfate
Given IV
|
|
Experimental: Regimen B (courses 3, 6, and 9)
Patients receive cyclophosphamide IV over 1 hour on days 1 and 2 and vincristine IV on days 1 and 8 of weeks 23, 39, and 55.
|
Drug: cyclophosphamide
Given IV
Drug: vincristine sulfate
Given IV
|
Show Detailed Description Eligibility| Ages Eligible for Study: | 3 Years to 21 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
DISEASE CHARACTERISTICS:
Histologically confirmed medulloblastoma located in the posterior fossa
- Standard-risk disease
Minimal volume, non-disseminated disease, defined by the following:
- Residual tumor ≤ 1.5 cm^2 confirmed by MRI with contrast imaging within 21 days after surgery
No metastatic disease in the head, spine, or cerebrospinal fluid (CSF) confirmed by both of the following:
- Enhanced MRI of the spine within 5 days before surgery OR within 28 days after surgery
- Negative cytological examination of CSF after surgery, but before study enrollment
- Brain stem involvement allowed
PATIENT CHARACTERISTICS:
Age
- 3 to 21 at diagnosis
Performance status
- Karnofsky 50-100% (> 16 years of age) OR
- Lansky 30-100% (≤ 16 years of age)
Life expectancy
- Not specified
Hematopoietic
- Absolute neutrophil count > 1,500/mm^3
- Platelet count > 100,000/mm^3 (transfusion independent)
- Hemoglobin > 10 g/dL (transfusions allowed)
Hepatic
- Bilirubin < 1.5 times upper limit of normal (ULN)
- AST or ALT < 1.5 times ULN
Renal
- Creatinine clearance OR radioisotope glomerular filtration rate ≥ 70 mL/min
Other
- Not pregnant or nursing
- Negative pregnancy test
- Fertile patients must use effective contraception
PRIOR CONCURRENT THERAPY:
Biologic therapy
- Not specified
Chemotherapy
- No prior chemotherapy
Endocrine therapy
- Prior corticosteroids allowed
Radiotherapy
- No prior radiotherapy
Surgery
- See Disease Characteristics
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00085735
Show 184 Study Locations
Show 184 Study LocationsSponsors and Collaborators
Children's Oncology Group
Investigators
| Study Chair: | Jeff M. Michalski, MD | Washington University Siteman Cancer Center |
More Information
Additional Information:
No publications provided
| Responsible Party: | Gregory H. Reaman, Children's Oncology Group - Group Chair Office |
| ClinicalTrials.gov Identifier: | NCT00085735 History of Changes |
| Other Study ID Numbers: | CDR0000365506, COG-ACNS0331 |
| Study First Received: | June 14, 2004 |
| Last Updated: | November 22, 2012 |
| Health Authority: | Unspecified |
Keywords provided by National Cancer Institute (NCI):
|
untreated childhood medulloblastoma |
Additional relevant MeSH terms:
|
Medulloblastoma Nervous System Neoplasms Central Nervous System Neoplasms Glioma Neoplasms, Neuroepithelial Neuroectodermal Tumors Neoplasms, Germ Cell and Embryonal Neoplasms by Histologic Type Neoplasms Neuroectodermal Tumors, Primitive Neoplasms, Glandular and Epithelial Neoplasms, Nerve Tissue Neoplasms by Site Nervous System Diseases Cisplatin |
Cyclophosphamide Lomustine Vincristine Antineoplastic Agents Therapeutic Uses Pharmacologic Actions Radiation-Sensitizing Agents Physiological Effects of Drugs Immunosuppressive Agents Immunologic Factors Antirheumatic Agents Antineoplastic Agents, Alkylating Alkylating Agents Molecular Mechanisms of Pharmacological Action Myeloablative Agonists |
ClinicalTrials.gov processed this record on May 16, 2013