Proton Beam Radiation Therapy in Treating Young Patients Who Have Undergone Biopsy or Surgery for Medulloblastoma or Pineoblastoma

NCT00105560 | Completed Results DMC

• 3 other identifiers: CDR0000415841P01CA021239MGH-99-271
• Study Type: interventional
• Target: 59
• Locations: 1 country
• Sites: 1

Brief Summary

RATIONALE: Specialized radiation therapy that delivers radiation directly to the area where a tumor was surgically removed may kill any remaining tumor cells and cause less damage to normal tissue. PURPOSE: This phase II trial is studying how well proton beam radiation therapy works in treating young patients who have undergone biopsy or surgery for medulloblastoma or pineoblastoma.

Conditions

Brain and Central Nervous System Tumors; Long-term Effects Secondary to Cancer Therapy in Children

Keywords

long-term effects secondary to cancer therapy in children; untreated childhood medulloblastoma; untreated childhood pineoblastoma

Outcome Measures

Primary Outcomes (1)

• Cumulative Incidence of Ototoxicity

  Percentage participants who experienced ototoxicity as measured by Common Toxicity Criteria for Adverse Events (CTCAE) v3.0 after the completion of radiation therapy in the overall participant population and by baseline measure subgroups. Incidence is shown after follow-up of 3 years, 5 years, 7 years, and 10 years.

  3 Years, 5 years, 7 years, 10 years

Secondary Outcomes (7)

• Cumulative Incidence of Endocrine Dysfunction (Neuroendocrine and End Organ Defects) at 3 Years

  3 years

• Cumulative Incidence of Endocrine Dysfunction (Neuroendocrine and End Organ Defects) at 5 Years

  5 years

• Cumulative Incidence of Endocrine Dysfunction (Neuroendocrine and End Organ Defects) at 7 Years

  7 years

• Cumulative Incidence of Endocrine Dysfunction (Neuroendocrine and End Organ Defects) at 7 Years

  3 years, 5 years, 7 years

• Mean Change Per-Year in Neurocognitive Outcomes

  Baseline, 1, 3, 5, 7 years

Study Arms (1)

Radiation therapy

EXPERIMENTAL

This is a single arm study of radiation therapy with protons to standard doses.

Radiation: radiation therapy

Interventions

radiation therapy RADIATION

Radiation therapy with proton beam to standard doses

Radiation therapy

Eligibility Criteria

• Age: 3 Years - 21 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

DISEASE CHARACTERISTICS: * Histologically confirmed medulloblastoma or pineoblastoma * Standard-risk or high-risk disease * Must have undergone biopsy or attempted surgical resection of the tumor within the past 35 days * Requires craniospinal irradiation PATIENT CHARACTERISTICS: Age * 3 to 21 Performance status * Not specified Life expectancy * Not specified Hematopoietic * Not specified Hepatic * Not specified Renal * Not specified Other * Not pregnant or nursing * Negative pregnancy test * Fertile patients must use effective contraception PRIOR CONCURRENT THERAPY: Biologic therapy * Not specified Chemotherapy * No more than 1 prior chemotherapy regimen * No prior IV or intrathecal methotrexate * No prior intrathecal thiotepa * Concurrent cisplatin-based chemotherapy, including chemotherapy administered on another study, allowed Endocrine therapy * Not specified Radiotherapy * No prior radiotherapy Surgery * See Disease Characteristics

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• Massachusetts General Hospital: lead
• National Cancer Institute (NCI): collaborator

Study Sites (1)

Massachusetts General Hospital

Boston, Massachusetts, 02114, United States

Location

Related Publications (2)

• Yock TI, Yeap BY, Ebb DH, Weyman E, Eaton BR, Sherry NA, Jones RM, MacDonald SM, Pulsifer MB, Lavally B, Abrams AN, Huang MS, Marcus KJ, Tarbell NJ. Long-term toxic effects of proton radiotherapy for paediatric medulloblastoma: a phase 2 single-arm study. Lancet Oncol. 2016 Mar;17(3):287-298. doi: 10.1016/S1470-2045(15)00167-9. Epub 2016 Jan 30.

  PMID: 26830377 RESULT

• Vatner RE, Niemierko A, Misra M, Weyman EA, Goebel CP, Ebb DH, Jones RM, Huang MS, Mahajan A, Grosshans DR, Paulino AC, Stanley T, MacDonald SM, Tarbell NJ, Yock TI. Endocrine Deficiency As a Function of Radiation Dose to the Hypothalamus and Pituitary in Pediatric and Young Adult Patients With Brain Tumors. J Clin Oncol. 2018 Oct 1;36(28):2854-2862. doi: 10.1200/JCO.2018.78.1492. Epub 2018 Aug 17.

  PMID: 30118397 DERIVED

MeSH Terms

Conditions

Central Nervous System Neoplasms

Interventions

Radiotherapy

Condition Hierarchy (Ancestors)

Nervous System Neoplasms; Neoplasms by Site; Neoplasms; Nervous System Diseases

Intervention Hierarchy (Ancestors)

Therapeutics

Results Point of Contact

• Title: Dr. Nancy Tarbell, Pediatric Radiation Oncologist
• Organization: Massachusetts General Hospital

NTARBELL@mgh.harvard.edu

617-724-1836

Study Officials

• Nancy J. Tarbell, MD

  Massachusetts General Hospital

  STUDY CHAIR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Attending Radiation Oncologist

Study Record Dates

• First Submitted: March 15, 2005
• First Posted: March 16, 2005
• Study Start: May 1, 2002
• Primary Completion: December 1, 2012
• Study Completion: December 1, 2020
• Last Updated: December 28, 2021
• Results First Posted: August 21, 2017

Record last verified: 2021-12

Locations

US (1)