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Radiation Therapy and Combination Chemotherapy for Medulloblastoma

Primary Purpose

Medulloblastoma

Status

Unknown status

Phase

Phase 2

Locations

China

Study Type

Interventional

Intervention

Temozolomide

Craniospinal Radiation

About this trial

This is an interventional treatment trial for Medulloblastoma

Eligibility Criteria

3 Years - 12 Years (Child)All SexesDoes not accept healthy volunteers

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

Sites / Locations

The Department of Radiation Oncology, Xin Hua Hospital Affiliated to Shanghai Jiao Tong University School of MedicineRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Study Treatment

Arm Description

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.

Outcomes

Primary Outcome Measures

Number of participants with treatment-related adverse events as assessed by CTCAE v4.0

Secondary Outcome Measures

Progression free survival(PFS)

Overall survival (OS)

Evaluate Rate of Late Neurotoxic Effects

Evaluate the late neurotoxic effects of low dose craniospinal radiation, including cognitive, endocrinologic and auditory function.

Full Information

NCT ID

NCT02681705

First Posted

February 10, 2016

Last Updated

August 16, 2016

Sponsor

Xinhua Hospital, Shanghai Jiao Tong University School of Medicine

1. Study Identification

Unique Protocol Identification Number

NCT02681705

Brief Title

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

2. Study Status

Record Verification Date

August 2016

Overall Recruitment Status

Unknown status

Study Start Date

January 2010 (undefined)

Primary Completion Date

December 2016 (Anticipated)

Study Completion Date

December 2016 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Xinhua Hospital, Shanghai Jiao Tong University School of Medicine

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Medulloblastoma

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

60 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Study Treatment

Arm Type

Experimental

Arm Description

Intervention Type

Drug

Intervention Name(s)

Temozolomide

Other Intervention Name(s)

brand names Temodar and Temodal and Temcad

Intervention Description

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).

Intervention Type

Radiation

Intervention Name(s)

Craniospinal Radiation

Other Intervention Name(s)

Radiation

Intervention Description

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).

Primary Outcome Measure Information:

Title

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

Secondary Outcome Measure Information:

Title

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

Title

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

Title

Evaluate Rate of Late Neurotoxic Effects

Description

Evaluate the late neurotoxic effects of low dose craniospinal radiation, including cognitive, endocrinologic and auditory function.

Time Frame

3 years

10. Eligibility

Sex

All

Minimum Age & Unit of Time

3 Years

Maximum Age & Unit of Time

12 Years

Accepts Healthy Volunteers

Eligibility Criteria

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

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

chuanying zhu, MD

Phone

862125076994

sdnanhai123@163.com

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

mawei jiang, MD

Organizational Affiliation

The Department of Radiation Oncology, Xin Hua Hospital affiliated to Shanghai Jiaotong University School of Medicine

Official's Role

Principal Investigator

Facility Information:

Facility Name

The Department of Radiation Oncology, Xin Hua Hospital Affiliated to Shanghai Jiao Tong University School of Medicine

City

Shanghai

State/Province

Shanghai

ZIP/Postal Code

200092

Country

China

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Chuanying zhu, MD

Phone

862125076994

sdnanhai123@163.com

First Name & Middle Initial & Last Name & Degree

Mawei Jiang, MD

12. IPD Sharing Statement

Plan to Share IPD

Yes

Learn more about this trial

Radiation Therapy and Combination Chemotherapy for Medulloblastoma

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