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R01CA249988

Project Grant

Overview

Grant Description
Comparison of Symptom Burden/Toxicity, Neurocognitive Change, and Functional Outcomes in Pediatric Brain Tumor Patients Treated with Proton vs. Photon Radiotherapy - Project Summary

Most children treated for cancer in the US will achieve long-term survival, presenting unique challenges for this growing population. Pediatric brain tumor survivors are particularly at risk for neurocognitive impairments, educational difficulties, social problems, and medical disabilities. Cranial radiation therapy is an essential lifesaving treatment but is associated with cognitive decline.

Proton beam radiation therapy (PBRT) is one of the most promising recent advances in pediatric brain tumor treatment. The proposed medical advantage of PBRT lies in the precision of radiation delivery with proton beams, depositing maximum dose to clinical targets while minimizing radiation to surrounding tissues. By reducing dose to healthy brain tissue, PBRT may spare cognitive functioning and reduce symptom burden better than conventional photon or X-ray irradiation (XRT), leading to greater functional independence in survivorship.

Using a model-based, accelerated longitudinal cohort comparison design, we will compare symptom burden/toxicity, neurocognitive change, and functional outcomes at multiple data points from the start of radiation through late survivorship in patients treated with PBRT versus XRT. The following aims are proposed:

(1) To compare symptom burden and toxicity by RT type in pediatric brain tumor patients and survivors,
(2) To compare change in neurocognitive outcomes over time by RT type,
(3) To compare functional outcomes in early and late survivorship by RT type, and
(4) To examine relations among symptom burden/toxicity, neurocognitive function, and functional outcomes as a function of RT type.

This proposal is consistent with NCI's objective to "reduce the long-term adverse effects of cancer and its treatment" in children and to "improve the quality of life for cancer patients, survivors, and their families." Neurocognitive late effects lead to significant educational, social, and occupational limitations for many survivors, greatly affecting their quality of life and functional independence long-term. Research is needed to determine which treatments are best able to limit the suffering associated with symptom burden and post-treatment neurocognitive decline.

Our results will have clinical value, providing a timely comparison of symptoms, neurocognitive changes, and functional outcomes between PBRT and XRT groups that will guide clinicians and families on the range of outcomes to expect after PBRT.
Funding Goals
TO DEVELOP THE MEANS TO CURE AS MANY CANCER PATIENTS AS POSSIBLE AND TO CONTROL THE DISEASE IN THOSE PATIENTS WHO ARE NOT CURED. CANCER TREATMENT RESEARCH INCLUDES THE DEVELOPMENT AND EVALUATION OF IMPROVED METHODS OF CANCER TREATMENT THROUGH THE SUPPORT AND PERFORMANCE OF BOTH FUNDAMENTAL AND APPLIED LABORATORY AND CLINICAL RESEARCH. RESEARCH IS SUPPORTED IN THE DISCOVERY, DEVELOPMENT, AND CLINICAL TESTING OF ALL MODES OF THERAPY INCLUDING: SURGERY, RADIOTHERAPY, CHEMOTHERAPY, AND BIOLOGICAL THERAPY INCLUDING MOLECULARLY TARGETED THERAPIES, BOTH INDIVIDUALLY AND IN COMBINATION. IN ADDITION, RESEARCH IS CARRIED OUT IN AREAS OF NUTRITIONAL SUPPORT, STEM CELL AND BONE MARROW TRANSPLANTATION, IMAGE GUIDED THERAPIES AND STUDIES TO REDUCE TOXICITY OF CYTOTOXIC THERAPIES, AND OTHER METHODS OF SUPPORTIVE CARE THAT MAY SUPPLEMENT AND ENHANCE PRIMARY TREATMENT. SMALL BUSINESS INNOVATION RESEARCH (SBIR) PROGRAM: TO EXPAND AND IMPROVE THE SBIR PROGRAM, TO INCREASE PRIVATE SECTOR COMMERCIALIZATION OF INNOVATIONS DERIVED FROM FEDERAL RESEARCH AND DEVELOPMENT, TO INCREASE SMALL BUSINESS PARTICIPATION IN FEDERAL RESEARCH AND DEVELOPMENT, AND TO FOSTER AND ENCOURAGE PARTICIPATION OF SOCIALLY AND ECONOMICALLY DISADVANTAGED SMALL BUSINESS CONCERNS AND WOMEN-OWNED SMALL BUSINESS CONCERNS IN TECHNOLOGICAL INNOVATION. SMALL BUSINESS TECHNOLOGY TRANSFER (STTR) PROGRAM: TO STIMULATE AND FOSTER SCIENTIFIC AND TECHNOLOGICAL INNOVATION THROUGH COOPERATIVE RESEARCH AND DEVELOPMENT CARRIED OUT BETWEEN SMALL BUSINESS CONCERNS AND RESEARCH INSTITUTIONS, TO FOSTER TECHNOLOGY TRANSFER BETWEEN SMALL BUSINESS CONCERNS AND RESEARCH INSTITUTIONS, TO INCREASE PRIVATE SECTOR COMMERCIALIZATION OF INNOVATIONS DERIVED FROM FEDERAL RESEARCH AND DEVELOPMENT, AND TO FOSTER AND ENCOURAGE PARTICIPATION OF SOCIALLY AND ECONOMICALLY DISADVANTAGED SMALL BUSINESS CONCERNS AND WOMEN-OWNED SMALL BUSINESS CONCERNS IN TECHNOLOGICAL INNOVATION.
Grant Program (CFDA)
Place of Performance
Houston, Texas 770303411 United States
Geographic Scope
Single Zip Code
Analysis Notes
Amendment Since initial award the End Date has been extended from 02/28/26 to 08/31/26 and the total obligations have increased 381% from $1,406,970 to $6,769,276.
Baylor College Of Medicine was awarded Pediatric Brain Tumor Patients: Proton vs. Photon Radiotherapy Project Grant R01CA249988 worth $6,769,276 from National Cancer Institute in March 2021 with work to be completed primarily in Houston Texas United States. The grant has a duration of 5 years 5 months and was awarded through assistance program 93.395 Cancer Treatment Research. The Project Grant was awarded through grant opportunity Research Project Grant (Parent R01 Clinical Trial Not Allowed).

Status
(Ongoing)

Last Modified 9/24/25

Period of Performance
3/1/21
Start Date
8/31/26
End Date
86.0% Complete

Funding Split
$6.8M
Federal Obligation
$0.0
Non-Federal Obligation
$6.8M
Total Obligated
100.0% Federal Funding
0.0% Non-Federal Funding

Activity Timeline

Interactive chart of timeline of amendments to R01CA249988

Subgrant Awards

Disclosed subgrants for R01CA249988

Transaction History

Modifications to R01CA249988

Additional Detail

Award ID FAIN
R01CA249988
SAI Number
R01CA249988-3073002203
Award ID URI
SAI UNAVAILABLE
Awardee Classifications
Private Institution Of Higher Education
Awarding Office
75NC00 NIH National Cancer Institute
Funding Office
75NC00 NIH National Cancer Institute
Awardee UEI
FXKMA43NTV21
Awardee CAGE
9Z482
Performance District
TX-09
Senators
John Cornyn
Ted Cruz

Budget Funding

Federal Account Budget Subfunction Object Class Total Percentage
National Cancer Institute, National Institutes of Health, Health and Human Services (075-0849) Health research and training Grants, subsidies, and contributions (41.0) $2,559,149 100%
Modified: 9/24/25