Clinical Trial: Radiation Therapy and Combination Chemotherapy for Medulloblastoma

Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Interventional

Official Title: Phase 2 Study of Radiation Therapy and Combination Chemotherapy Following Surgery in Treating Children With Newly Diagnosed Medulloblastoma

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 Summary:

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.


Sponsor: Xinhua Hospital, Shanghai Jiao Tong University School of Medicine

Current Primary Outcome: 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 ]

Original Primary Outcome: Same as current

Current Secondary Outcome:

  • 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 ]
  • 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 ]
  • Evaluate Rate of Late Neurotoxic Effects [ Time Frame: 3 years ]
    Evaluate the late neurotoxic effects of low dose craniospinal radiation, including cognitive, endocrinologic and auditory function.


Original Secondary Outcome: Same as current

Information By: Xinhua Hospital, Shanghai Jiao Tong University School of Medicine

Dates:
Date Received: February 10, 2016
Date Started: January 2010
Date Completion: December 2016
Last Updated: August 16, 2016
Last Verified: August 2016