- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02681705
Radiation Therapy and Combination Chemotherapy for Medulloblastoma
Phase 2 Study of Radiation Therapy and Combination Chemotherapy Following Surgery in Treating Children With Newly Diagnosed Medulloblastoma
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
OUTLINE:
Adjuvant induction chemoradiotherapy: Beginning within 28 days after prior resection, patients undergo radiotherapy to the craniospinal axis 5 days a week for 4 weeks and then conformal radiotherapy to the tumor bed 5 days a week for 2 weeks. Beginning 1 week after the initiation of radiotherapy, Temozolomide is applied to these patients as a chemotherapy drug with a dosage of 75mg/m2, daily. The chemotherapy and radiation are combined as temozolomide is taken 1 hour prior to every fraction of radiotherapy.
Maintenance chemotherapy: Beginning 4 weeks after the completion of induction chemoradiotherapy, patients receive eight 4-week cycles of temozolomide (dosage: the 1st cycle, 150mg/m2, daily × 5 days, 4 weeks a cycle; the 2-8th cycle, 200mg/m2, daily × 5 days, 4 weeks a cycle and repeated again).
PROJECTED ACCRUAL: A total of 60 patients will be accrued for this study.
Study Type
Enrollment (Anticipated)
Phase
- Phase 2
Contacts and Locations
Study Locations
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Shanghai
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Shanghai, Shanghai, China, 200092
- Recruiting
- The Department of Radiation Oncology, Xin Hua Hospital Affiliated to Shanghai Jiao Tong University School of Medicine
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Contact:
- chuanying zhu, MD
- Phone Number: 862125076994
- Email: sdnanhai123@163.com
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Principal Investigator:
- Mawei Jiang, MD
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Histologically confirmed posterior fossa medulloblastoma
- No residual tumor greater than 1.5 cm^2 after resection by postoperative MRI No tumor in the spinal or cerebral subarachnoid space by MRI No tumor in the subarachnoid space by Cerebrospinal fluid (CSF) No failure to perform staging studies (spine MRI and CSF cytology) preoperatively or postoperatively
- Must begin radiotherapy on study within 28 days after surgery
Exclusion Criteria:
- Prior radiotherapy and anti-tumor chemotherapy other than corticosteroids are not allowed.
- Patients must begin radiotherapy on protocol within 28 days of completion of surgery. Exceptions need to be approved by the Principal Investigator.
- Patients with the following will not be eligible:
> 1.5cm3 residual tumor following resection as indicated by post-operative MRI. tumor in spinal or cerebral subarachnoid space either by MRI of brain and spine tumor in subarachnoid space by CSF cytology failure to perform staging studies (spine MRI, CSF cytology) either pre- or post- operatively
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Study Treatment
All subjects will undergo routine surgical staging of their tumor.
Treatment must begin within 28 days of surgery.
Craniospinal Radiation therapy will last for 6 weeks, five days per week.
Once a week during radiation, subjects will also be treated with Temozolomide.
Temozolomide is applied to these patients as a chemotherapy drug with a dosage of 75mg/m2, daily.
The chemotherapy and radiation therapy are combined as Temozolomide is taken 1 hour prior to every fraction of radiotherapy.
In 4 weeks after the completion of radiotherapy, temozolomide is given for 8 cycles.
|
Temozolomide is applied to these patients as a chemotherapy drug with a dosage of 75mg/m2, daily.
The chemotherapy and radiation are combined as temozolomide is taken 1 hour prior to every fraction of radiotherapy.
In 4 weeks after the completion of radiotherapy, temozolomide is given for 8 cycles (dosage: the 1st cycle, 150mg/m2, daily × 5 days, 4 weeks a cycle; the 2-8th cycle, 200mg/m2, daily × 5 days, 4 weeks a cycle and repeated again).
Other Names:
Craniospinal radiation will begin within 28 days of surgery.
Craniospinal Radiation therapy will last for 6 weeks, five days per week.
Once a week during radiation, subjects will also be treated with chemotherapy (Temozolomide).
Other Names:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Number of participants with treatment-related adverse events as assessed by CTCAE v4.0
Time Frame: first analysis will occur 1 month after accrual of all patients
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first analysis will occur 1 month after accrual of all patients
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Progression free survival(PFS)
Time Frame: From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 24 months
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From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 24 months
|
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Overall survival (OS)
Time Frame: From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 24 months
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From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 24 months
|
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Evaluate Rate of Late Neurotoxic Effects
Time Frame: 3 years
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Evaluate the late neurotoxic effects of low dose craniospinal radiation, including cognitive, endocrinologic and auditory function.
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3 years
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Collaborators and Investigators
Investigators
- Principal Investigator: mawei jiang, MD, The Department of Radiation Oncology, Xin Hua Hospital affiliated to Shanghai Jiaotong University School of Medicine
Study record dates
Study Major Dates
Study Start
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Neoplasms by Histologic Type
- Neoplasms
- Neoplasms, Glandular and Epithelial
- Glioma
- Neoplasms, Neuroepithelial
- Neuroectodermal Tumors
- Neoplasms, Germ Cell and Embryonal
- Neoplasms, Nerve Tissue
- Neuroectodermal Tumors, Primitive
- Medulloblastoma
- Molecular Mechanisms of Pharmacological Action
- Antineoplastic Agents
- Antineoplastic Agents, Alkylating
- Alkylating Agents
- Temozolomide
Other Study ID Numbers
- sanghaixinhua-003
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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