LET Optimized IMPT in Treating Pediatric Patients With Ependymoma

Ependymoma Clinical Trial

Official title:

Pilot Trial of LET Optimized IMPT for Pediatric Patients With Ependymoma

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03750513
• Other study ID #: 2018-0344
• Secondary ID: NCI-2018-0251920
• Status: Recruiting
• Phase: Phase 1
• Start date: April 1, 2019
• Est. completion date: December 31, 2027

Study information

• Verified date: May 2024
• Source: M.D. Anderson Cancer Center
• Contact: David Grosshans
• Phone: 713-563-2300
• Email: dgrossha[@]mdanderson.org
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This phase I trial studies the side effects of linear energy transfer (LET) optimized image modulated proton therapy (IMPT) in treating pediatric patients with ependymoma. Radiation therapy such as LET optimized IMPT, uses proton beams to kill tumor cells and shrink tumors without damaging surrounding normal tissues.

Description:

PRIMARY OBJECTIVES: I. To evaluate the safety of linear energy transfer (LET) optimized image modulated proton therapy (IMPT) (bio-IMPT) for pediatric patients with ependymoma. SECONDARY OBJECTIVES: I. To utilize advanced multiparametric magnetic resonance (MR) imaging to identify imaging biomarkers of structural and biological changes after proton therapy in pediatric ependymoma patients. II. To compare quantitative image biomarkers in patients treated with bio-IMPT and standard proton therapy using a voxel level analysis. III. To test and evaluate the validity of relative biological effectiveness (RBE) models and enhance their precision based on prospectively collected clinical image biomarkers. IV. To evaluate acute and late toxicities, including pseudoprogression and symptom burden, in patients treated with bio-IMPT. V. To estimate progression-free survival (PFS) and overall survival (OS). VI. To evaluate disease outcomes following the use of a simultaneous integrated boost (SIB) for pediatric ependymoma patients with gross residual disease following surgery. OUTLINE: Patients receive LET optimized IMPT for up to 6 weeks. After completion of study treatment, patients are followed up at 1 month, then every 3 months for up to 24 months.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 48
• Est. completion date: December 31, 2027
• Est. primary completion date: December 31, 2027
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A to 22 Years

Eligibility

Inclusion Criteria:

• Previous pathologic confirmation of ependymoma, World Health Organization (WHO) grade II or III
• Disease must be confined to the brain (no evidence of spread on MR imaging of the spine or on staging lumbar puncture)
• Patient may not receive chemotherapy concurrent with radiation
• Signed informed consent by patient and/or parents or legal guardian
• Lansky performance status score of 50 -100

Exclusion Criteria:

• Patients with previous radiation therapy to the brain
• Ependymoma of the spine
• Disseminated ependymoma requiring craniospinal radiation therapy
• Pregnancy
• Inability to undergo MR imaging
• Inability to receive gadolinium-based contrast agent

Related Conditions & MeSH terms

• Anaplastic Ependymoma
• Ependymoma

Intervention

Radiation:
• Linear Energy Transfer-Optimized Intensity Modulated Proton Therapy
Given LET optimized IMPT

Other:
• Quality-of-Life Assessment
Ancillary studies
• Questionnaire Administration
Ancillary studies

Locations

Country	Name	City	State
United States	Massachusetts General Hospital Cancer Center	Boston	Massachusetts
United States	M D Anderson Cancer Center	Houston	Texas

Sponsors (2)

Lead Sponsor	Collaborator
M.D. Anderson Cancer Center	National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Incidence of adverse events	The safety of linear energy transfer-optimized intensity modulated proton therapy will be defined by treatment failures which include imaging changes consistent with necrosis in the presence of Common Terminology Criteria for Adverse Events version 4.03 symptoms of grade 3 brain necrosis and/or local recurrence within the first 6 months from the end of proton therapy.	Up to 6 months post treatment
Secondary	Identify imaging biomarkers of structural and biological changes after proton therapy	Descriptive statistics will be used to summarize the study data.	Up to 24 months post-treatment
Secondary	Quantitative image biomarkers	Descriptive statistics will be used to summarize the study data.	Up to 24 months post-treatment
Secondary	Validity of relative biological effectiveness models	Descriptive statistics will be used to summarize the study data.	Up to 24 months post-treatment
Secondary	Incidence of late and acute toxicities	Descriptive statistics will be used to summarize the study data. For each study cohort, we will tabulate treatment- failures and other relevant clinically-related features. Interval estimates for proportions will be provided using exact 95% confidence intervals.	Up to 24 months post treatment
Secondary	Progression-free survival	The method of Kaplan and Meier will be used to provide estimates.	Up to 24 months post treatment
Secondary	Overall survival	The method of Kaplan and Meier will be used to provide estimates.	Up to 24 months post treatment
Secondary	Disease outcomes following the use of a simultaneous integrated boost	Descriptive statistics will be used to summarize the study data.	Up to 24 months post-treatment

External Links

•   MD Anderson Cancer Center Website