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Palliative Spatially Fractionated (GRID) Radiotherapy Using Intensity Modulated Proton Therapy

Primary Purpose

Unresectable Solid Tumor, Metastatic Cancer

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Proton GRID Radiotherapy
Sponsored by
Washington University School of Medicine
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Unresectable Solid Tumor focused on measuring proton, palliative radiotherapy, spatially fractionated radiotherapy, GRID, stereotactic body radiotherapy (SBRT), stereotactic ablative radiotherapy (SABR), cancer

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: Histologically or cytologically confirmed cancer diagnosis. Planning to undergo palliative radiotherapy to unresectable or metastatic target lesion ≥ 4.5 cm in any dimension as measured with radiographic imaging or with calipers by clinical exam. Cohort A: 10 patients with lesions that have been previously irradiated. Cohort B: 10 patients with lesions that have not been previously irradiated. ECOG performance status ≤ 3 At least 18 years of age. Radiotherapy is known to be teratogenic. For this reason, women of childbearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control, abstinence) prior to study entry and for the duration of study participation. Should a woman become pregnant or suspect she is pregnant while participating in this study, she must inform her treating physician immediately. Men treated or enrolled on this protocol must also agree to use adequate contraception prior to the study, for the duration of the study, and 6 months after completion of the study Ability to understand and willingness to sign an IRB approved written informed consent document (or that of legally authorized representative, if applicable). Exclusion Criteria: Patients with tumors in need of urgent surgical intervention, such as life-threatening bleeding or those at high risk for pathologic fracture and amenable to surgical intervention. Patients with a superficial target lesion ≤ 1 cm deep to skin surface who initially had a superficial lesion irradiated, if the target lesion was in the area of the prior irradiation. Currently receiving any cytotoxic cancer therapy regimens or VEGF inhibitors that will overlap with the proton GRID administration. Cytotoxic chemotherapy and VEGF inhibitors prior to radiotherapy or planned after radiotherapy delivery are allowed at the discretion of the treating radiation oncologist. This includes continuing a treatment plan which was initiated prior to the start of radiotherapy. A 2-week washout is recommended, but not required. Pregnant. Women of childbearing potential must have a negative pregnancy test within 20 days of study entry. Patients with HIV are eligible unless their CD4+ T-cell counts are < 350 cells/mcL or they have a history of AIDS-defining opportunistic infection within the 12 months prior to registration. Concurrent treatment with effective ART according to DHHS treatment guidelines is recommended.

Sites / Locations

  • Washington University School of MedicineRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Cohort A: Reirradiation of Treatment Fields

Cohort B: De Novo Radiation Treatment Fields

Arm Description

Radiotherapy will consist of 20 Gy proton GRID radiotherapy x 3 fractions.

Radiotherapy will consist of 20 Gy proton GRID radiotherapy x 3 fractions.

Outcomes

Primary Outcome Measures

Rate of treatment-related acute toxicity
-Grade per CTCAE v5.0.
Rate of treatment-related late toxicity
-Grade per CTCAE v5.0.

Secondary Outcome Measures

Change in PRO-CTCAE assessment
PRO-CTCAE is a standardized inventory to collected patient reported symptomatic adverse events in clinical trials.
Change in PROMIS Global Health
PROMIS Global Health is a 10-item patient-reported questionnaire that assesses health related quality of life compared with normal values for the general population with the response options presented as a 5-point (as well as a single 11-point) rating scale. The question that uses an 11-point scale uses a response scale of 0-10 that is recoded to 5 categories (0 = 1; 1-3 = 2; 4-6 = 3; 7-9 = 4; 10 = 5). The results of the questions are used to calculate two summary scores: a Global Physical Health Score and a Global Mental Health score. These scores are then standardized to the general population, using the "T-Score". The average "T-Score" for the United States population is 50 points, with a standard deviation of 10 points. Higher scores are indicative of a healthier patient.
Rate of target lesion local control

Full Information

First Posted
April 13, 2023
Last Updated
October 2, 2023
Sponsor
Washington University School of Medicine
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1. Study Identification

Unique Protocol Identification Number
NCT05831579
Brief Title
Palliative Spatially Fractionated (GRID) Radiotherapy Using Intensity Modulated Proton Therapy
Official Title
A Phase I Trial of Palliative Spatially Fractionated (GRID) Radiotherapy Using Intensity Modulated Proton Therapy
Study Type
Interventional

2. Study Status

Record Verification Date
October 2023
Overall Recruitment Status
Recruiting
Study Start Date
May 12, 2023 (Actual)
Primary Completion Date
May 31, 2025 (Anticipated)
Study Completion Date
May 31, 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Washington University School of Medicine

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
Spatially fractionated radiotherapy (SFRT or GRID) addresses some limitations of traditional stereotactic body radiation therapy by relying on beam collimation to create high-dose "peaks" and intervening low-dose "valleys" throughout the target volume. Standard palliative radiotherapy regimens provide limited durability of response, and there are challenges with delivery to large tumors or in previously irradiated fields. In this study, Proton GRID radiotherapy will be used to deliver three-fraction palliative radiotherapy to patients with tumors needing palliative radiation. The safety and efficacy of this approach will be assessed. It is hypothesized that GRID is highly effective, immunogenic, and associated with low rates of toxicity.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Unresectable Solid Tumor, Metastatic Cancer
Keywords
proton, palliative radiotherapy, spatially fractionated radiotherapy, GRID, stereotactic body radiotherapy (SBRT), stereotactic ablative radiotherapy (SABR), cancer

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Sequential Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
20 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Cohort A: Reirradiation of Treatment Fields
Arm Type
Experimental
Arm Description
Radiotherapy will consist of 20 Gy proton GRID radiotherapy x 3 fractions.
Arm Title
Cohort B: De Novo Radiation Treatment Fields
Arm Type
Experimental
Arm Description
Radiotherapy will consist of 20 Gy proton GRID radiotherapy x 3 fractions.
Intervention Type
Radiation
Intervention Name(s)
Proton GRID Radiotherapy
Intervention Description
The proton GRID radiotherapy prescription dose is 20 Gy x 3 fractions to the tumor, with an integrated dose of 6 Gy x 3 fractions to the PTV. Treatment to multiple lesions within the PTV is allowed (ex. a dominant lesion plus satellites). Multiple proton GRID radiotherapy plans may be delivered on the same day or different days, but they cannot overlap.
Primary Outcome Measure Information:
Title
Rate of treatment-related acute toxicity
Description
-Grade per CTCAE v5.0.
Time Frame
From start of treatment through 90 days
Title
Rate of treatment-related late toxicity
Description
-Grade per CTCAE v5.0.
Time Frame
From day 91 through 12 months
Secondary Outcome Measure Information:
Title
Change in PRO-CTCAE assessment
Description
PRO-CTCAE is a standardized inventory to collected patient reported symptomatic adverse events in clinical trials.
Time Frame
Baseline, 14 days, 30 days, 3 months, 6 months, and 12 months
Title
Change in PROMIS Global Health
Description
PROMIS Global Health is a 10-item patient-reported questionnaire that assesses health related quality of life compared with normal values for the general population with the response options presented as a 5-point (as well as a single 11-point) rating scale. The question that uses an 11-point scale uses a response scale of 0-10 that is recoded to 5 categories (0 = 1; 1-3 = 2; 4-6 = 3; 7-9 = 4; 10 = 5). The results of the questions are used to calculate two summary scores: a Global Physical Health Score and a Global Mental Health score. These scores are then standardized to the general population, using the "T-Score". The average "T-Score" for the United States population is 50 points, with a standard deviation of 10 points. Higher scores are indicative of a healthier patient.
Time Frame
Baseline, 14 days, 30 days, 3 months, 6 months, and 12 months
Title
Rate of target lesion local control
Time Frame
3 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Histologically or cytologically confirmed cancer diagnosis. Planning to undergo palliative radiotherapy to unresectable or metastatic target lesion ≥ 4.5 cm in any dimension as measured with radiographic imaging or with calipers by clinical exam. Cohort A: 10 patients with lesions that have been previously irradiated. Cohort B: 10 patients with lesions that have not been previously irradiated. ECOG performance status ≤ 3 At least 18 years of age. Radiotherapy is known to be teratogenic. For this reason, women of childbearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control, abstinence) prior to study entry and for the duration of study participation. Should a woman become pregnant or suspect she is pregnant while participating in this study, she must inform her treating physician immediately. Men treated or enrolled on this protocol must also agree to use adequate contraception prior to the study, for the duration of the study, and 6 months after completion of the study Ability to understand and willingness to sign an IRB approved written informed consent document (or that of legally authorized representative, if applicable). Exclusion Criteria: Patients with tumors in need of urgent surgical intervention, such as life-threatening bleeding or those at high risk for pathologic fracture and amenable to surgical intervention. Patients with a superficial target lesion ≤ 1 cm deep to skin surface who initially had a superficial lesion irradiated, if the target lesion was in the area of the prior irradiation. Currently receiving any cytotoxic cancer therapy regimens or VEGF inhibitors that will overlap with the proton GRID administration. Cytotoxic chemotherapy and VEGF inhibitors prior to radiotherapy or planned after radiotherapy delivery are allowed at the discretion of the treating radiation oncologist. This includes continuing a treatment plan which was initiated prior to the start of radiotherapy. A 2-week washout is recommended, but not required. Pregnant. Women of childbearing potential must have a negative pregnancy test within 20 days of study entry. Patients with HIV are eligible unless their CD4+ T-cell counts are < 350 cells/mcL or they have a history of AIDS-defining opportunistic infection within the 12 months prior to registration. Concurrent treatment with effective ART according to DHHS treatment guidelines is recommended.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Anthony Apicelli, M.D.
Phone
314-362-8610
Email
apicella@wustl.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Anthony Apicelli, M.D.
Organizational Affiliation
Washington University School of Medicine
Official's Role
Principal Investigator
Facility Information:
Facility Name
Washington University School of Medicine
City
Saint Louis
State/Province
Missouri
ZIP/Postal Code
63110
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Anthony Apicelli, M.D.
Phone
314-362-8610
Email
apicella@wustl.edu
First Name & Middle Initial & Last Name & Degree
Anthony Apicelli, M.D.
First Name & Middle Initial & Last Name & Degree
Clifford Robinson, M.D.
First Name & Middle Initial & Last Name & Degree
Stephanie Perkins, M.D.
First Name & Middle Initial & Last Name & Degree
Jeff Szymanski, M.D., Ph.D.
First Name & Middle Initial & Last Name & Degree
Justin Barnes, M.D.
First Name & Middle Initial & Last Name & Degree
Nels Knutson, Ph.D.
First Name & Middle Initial & Last Name & Degree
Yi Huang, M.S.
First Name & Middle Initial & Last Name & Degree
Michael Prusator, Ph.D.
First Name & Middle Initial & Last Name & Degree
Tianyu Zhao, Ph.D.
First Name & Middle Initial & Last Name & Degree
Xiandong Zhao, Ph.D.

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
Available data will include de-identified individual participant data collected during the trial.
IPD Sharing Time Frame
Beginning 3 months after publication. No end date
IPD Sharing Access Criteria
Researchers who provide a methodologically sound proposal may be granted data access. Proposals should be directed to apicellia@wustl.edu. To gain access, data requestors will need to sign a data access agreement.
Links:
URL
http://www.siteman.wustl.edu
Description
Alvin J. Siteman Cancer Center at Barnes-Jewish Hospital and Washington University School of Medicine

Learn more about this trial

Palliative Spatially Fractionated (GRID) Radiotherapy Using Intensity Modulated Proton Therapy

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