Clinical trial NCT02681705: Radiation Therapy and Combination Chemotherapy for Medulloblastoma
Official title: Phase 2 Study of Radiation Therapy and Combination Chemotherapy Following Surgery in Treating Children With Newly Diagnosed Medulloblastoma
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
Conditions: Medulloblastoma
Lead sponsor: Xinhua Hospital, Shanghai Jiao Tong University School of Medicine
Sponsor class: OTHER
First posted: 2016-02-12
Enrollment: 60
Sex: ALL
Minimum age (years): 3
Maximum age (years): 12
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This phase II trial is studying giving radiation therapy together with combination chemotherapy after surgery to see how well it works in treating children with newly diagnosed medulloblastoma.

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.

Eligibility criteria: Inclusion Criteria:

1. Histologically confirmed posterior fossa medulloblastoma
2. 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
3. Must begin radiotherapy on study within 28 days after surgery

Exclusion Criteria:

1. Prior radiotherapy and anti-tumor chemotherapy other than corticosteroids are not allowed.
2. Patients must begin radiotherapy on protocol within 28 days of completion of surgery. Exceptions need to be approved by the Principal Investigator.
3. 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

Primary outcomes:
measure: Number of participants with treatment-related adverse events as assessed by CTCAE v4.0
timeFrame: first analysis will occur 1 month after accrual of all patients
Secondary outcomes:
measure: Progression free survival(PFS)
timeFrame: 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
measure: Overall survival (OS)
timeFrame: 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
measure: Evaluate Rate of Late Neurotoxic Effects
timeFrame: 3 years
Other outcomes:
Locations:
city: Shanghai
country: China
facility: The Department of Radiation Oncology, Xin Hua Hospital Affiliated to Shanghai Jiao Tong University School of Medicine
state: Shanghai
Study officials:
affiliation: The Department of Radiation Oncology, Xin Hua Hospital affiliated to Shanghai Jiaotong University School of Medicine
name: mawei jiang, MD
role: PRINCIPAL_INVESTIGATOR
References: