Clinical trial NCT03750513: LET Optimized IMPT in Treating Pediatric Patients With Ependymoma
Official title: Pilot Trial of LET Optimized IMPT for Pediatric Patients With Ependymoma
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE1
Conditions: Anaplastic Ependymoma
Ependymoma
Lead sponsor: M.D. Anderson Cancer Center
Sponsor class: OTHER
Collaborators: name: National Cancer Institute (NCI)
First posted: 2018-11-23
Enrollment: 48
Sex: ALL
Maximum age (years): 22
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief 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.

Detailed 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.

Eligibility criteria: 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

Primary outcomes:
measure: Incidence of adverse events
timeFrame: Up to 6 months post treatment
Secondary outcomes:
measure: Identify imaging biomarkers of structural and biological changes after proton therapy
timeFrame: Up to 24 months post-treatment
measure: Quantitative image biomarkers
timeFrame: Up to 24 months post-treatment
measure: Validity of relative biological effectiveness models
timeFrame: Up to 24 months post-treatment
measure: Incidence of late and acute toxicities
timeFrame: Up to 24 months post treatment
measure: Progression-free survival
timeFrame: Up to 24 months post treatment
measure: Overall survival
timeFrame: Up to 24 months post treatment
measure: Disease outcomes following the use of a simultaneous integrated boost
timeFrame: Up to 24 months post-treatment
Other outcomes:
Locations:
city: Boston
country: United States
facility: Massachusetts General Hospital Cancer Center
state: Massachusetts
city: Houston
country: United States
facility: M D Anderson Cancer Center
state: Texas
Study officials:
affiliation: M.D. Anderson Cancer Center
name: David R Grosshans
role: PRINCIPAL_INVESTIGATOR
References: