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

• Status: Unknown
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 60 (estimated)
• Sponsor: Xinhua Hospital, Shanghai Jiao Tong University School of Medicine · Academic / Other
• Sex: All
• Age: 3 Years – 12 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Medulloblastoma

Interventions

Type	Name	Description
DRUG	Temozolomide	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).
RADIATION	Craniospinal Radiation	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).

Timeline

• Start date: 2010-01-01
• Primary completion: 2016-12-01
• Completion: 2016-12-01
• First posted: 2016-02-12
• Last updated: 2016-08-17

Locations

1 site across 1 country: China