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Integrating patient-specific clinical and biological factors towards individualizing utilization of proton and photon radiation therapy.

Award Number: P01CA261669
ORGANIZATION: NATIONAL CANCER INSTITUTE
OPDIV: NIH
AWARD CLASS: DISCRETIONARY
AWARD ACTIVITY TYPE: SCIENTIFIC/HEALTH RESEARCH (INCLUDES SURVEYS)
PERIOD OF PERFORMANCE START DATE: 09/21/2021
PERIOD OF PERFORMANCE END DATE: 08/31/2026

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Integrating patient-specific clinical and biological factors towards individualizing utilization of proton and photon radiation therapy. - OVERALL - SUMMARY This is a joint application for a program project grant by Massachusetts General Hospital and MD Anderson Cancer Center. The progress we made in our most recent program projects (a P01 and a U19) has been criti- cal to the clinical, physical, and biological aspects of proton therapy and its significance as an important cancer treatment modality. The main achievements of the recently completed U19 (end date 8/31/20) were (1) the de- velopment and activation of definitive esophagus, liver and glioma randomized proton vs. photon therapy trials in cooperation with NRG, NCI and NCTN; (2) understanding and modeling the differences in response of nor- mal tissues to highly disparate proton and photon dose distribution patterns; (3) understanding the complexities of the biological effects of protons relative to photons; and (4) the development of advanced intensity modu- lated proton therapy incorporating physical uncertainties and the variable biological effectiveness of protons. Our research also revealed major gaps in the knowledge of the biological effects of protons, significant limita- tions of the current population-based models of normal tissue and tumor response to protons vs. photons, and uncertainty in the appropriateness of proton therapy in the face of heterogeneities in patient characteristics and treatment techniques in unselected groups of patients. On the bright side, our research also discovered the strong potential of proton therapy to reduce suppression of the immune system, which is commonly associated with photon therapy and has been shown to lead to adverse outcomes. The overall goals of the proposed P01 are (a) understanding relative clinical, biological and immunosuppressive effects of proton therapy vs. photon therapy; (b) enhancing outcomes based on the physical, biological and immunological properties of protons and photons; and (c) applying individualized (as opposed to population-based) approaches for the se- lection of the optimum radiation modality for each patient and to enhance the potential for outcomes with the use of radiation dose distributions tailored to the individual patient’s baseline and tumor characteristics. The achievement of these goals will be carried out in three projects. Project 1: Understanding Normal Tissue Tox- icity to Identify Patients Most Likely to Benefit from Proton vs. Photon Therapy; Project 2: Radiation-Induced Lymphopenia (RIL): Understanding, Predictive Modeling and Developing Photon and Proton-Based Mitigation Strategies; and Project 3: Investigating Enhanced Sensitivity of Tumors to Proton Beam Therapy: Mechanisms and Biomarkers. The projects are highly integrated in that decisions regarding treatment modality selection, treatment technique and optimization to maximally enhance the therapeutic ratio cannot be accomplished by any one project alone. Such decisions must consider and balance normal tissue complications, tumor re- sponse based on genotypic factors, and radiation-induced immunosuppression. The three projects will be sup- ported by an Administrative Core and three resource cores: Core 1: Data Management and Computational Support; Core 2: Translational Biospecimens and Imaging Biomarkers; and Core 3: Biostatistics.


Issue Date FY	Funding FY	Legal Entity Name	Legal Entity Address	Legal Entity City	Legal Entity State	Legal Entity Zip Code	Legal Entity COUNTY	Legal Entity COUNTRY	Assistance Listing	Award Code	Budget Year	Action Date	Action Type	Action Amount

Issue Date FY: 2026 ( Subtotal = $0 )
2026	2025	THE GENERAL HOSPITAL CORPORATION	55 FRUIT ST	BOSTON	MA	02114	SUFFOLK	USA	Cancer Treatment Research	000	5	12/10/2025	NON-COMPETING CONTINUATION	$0
														Subtotal = $0

Issue Date FY: 2025 ( Subtotal = $2,749,617 )
2025	2025	THE GENERAL HOSPITAL CORPORATION	55 FRUIT ST	BOSTON	MA	02114	SUFFOLK	USA	Cancer Treatment Research	001	5	9/9/2025	NON-COMPETING CONTINUATION	$2,749,617
2025	2024	THE GENERAL HOSPITAL CORPORATION	55 FRUIT ST	BOSTON	MA	02114	SUFFOLK	USA	21st Century Cures Act - Beau Biden Cancer Moonshot	000	4	10/18/2024	SUPPLEMENT FOR EXPANSION	$0
														Subtotal = $2,749,617

Issue Date FY: 2024 ( Subtotal = $2,863,084 )
2024	2024	THE GENERAL HOSPITAL CORPORATION	55 FRUIT ST	BOSTON	MA	02114	SUFFOLK	USA	Cancer Treatment Research	000	4	9/5/2024	NON-COMPETING CONTINUATION	$2,613,084
2024	2024	THE GENERAL HOSPITAL CORPORATION	55 FRUIT ST	BOSTON	MA	02114	SUFFOLK	USA	21st Century Cures Act - Beau Biden Cancer Moonshot	001	4	9/20/2024	SUPPLEMENT FOR EXPANSION	$250,000
														Subtotal = $2,863,084

Issue Date FY: 2023 ( Subtotal = $2,722,827 )
2023	2023	THE GENERAL HOSPITAL CORPORATION	55 FRUIT ST	BOSTON	MA	02114	SUFFOLK	USA	Cancer Treatment Research	000	3	9/15/2023	NON-COMPETING CONTINUATION	$2,722,827
														Subtotal = $2,722,827

Issue Date FY: 2022 ( Subtotal = $2,701,684 )
2022	2022	MASSACHUSETTS GENERAL HOSPITAL, THE	55 FRUIT ST	BOSTON	MA	02114	SUFFOLK	USA	Cancer Treatment Research	001	2	8/26/2022	NON-COMPETING CONTINUATION	$2,701,684
2022	2021	MASSACHUSETTS GENERAL HOSPITAL, THE	55 FRUIT ST	BOSTON	MA	02114	SUFFOLK	USA	Cancer Treatment Research	000	1	1/13/2022	NEW	$0
														Subtotal = $2,701,684

Issue Date FY: 2021 ( Subtotal = $2,940,354 )
2021	2021	MASSACHUSETTS GENERAL HOSPITAL, THE	55 FRUIT ST	BOSTON	MA	02114	SUFFOLK	USA	Cancer Treatment Research	000	1	9/21/2021	NEW	$2,940,354
														Subtotal = $2,940,354

Grand Total All Awards = $13,977,566

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Integrating patient-specific clinical and biological factors towards individualizing utilization of proton and photon radiation therapy.

Award Number: P01CA261669

ORGANIZATION: NATIONAL CANCER INSTITUTE

OPDIV: NIH

AWARD CLASS: DISCRETIONARY

AWARD ACTIVITY TYPE: SCIENTIFIC/HEALTH RESEARCH (INCLUDES SURVEYS)

PERIOD OF PERFORMANCE START DATE: 09/21/2021

PERIOD OF PERFORMANCE END DATE: 08/31/2026

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