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A Study of Reduced-dose Radiation in People With Metastatic Tumors With a Genetic Change

Primary Purpose

Metastatic Cancer

Status
Recruiting
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Palliative radiotherapy
Sponsored by
Memorial Sloan Kettering Cancer Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Metastatic Cancer focused on measuring Reduced-dose Radiation, Pathogenic Mutations, ATM (ataxia telangiectasia mutated), 21-310

Eligibility Criteria

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

Inclusion Criteria:

  • Histologically confirmed malignancy with at least one metastatic lesion referred for palliative radiotherapy
  • Pathogenic mutation in ATM (somatic and germline allowed)
  • ECOG performance status 0-2
  • Age ≥ 18 years.
  • Able to provide informed consent.
  • Patients at reproductive potential must agree to practice an effective contraceptive method during radiation treatments.
  • Expected life expectancy of at least 6 months

Exclusion Criteria:

  • Previous radiotherapy to the intended treatment site that precludes developing a treatment plan that respects normal tissue tolerances.
  • Serious medical co-morbidities precluding radiotherapy.
  • Pregnant or breast-feeding women.
  • Concomitant pathogenic mutation in p53
  • Lesions excluded from de-escalation include regions in which the risk of local disease progression is unacceptably high, including CNS disease and cord compression, and areas in which re-irradiation would not be feasible, including spinal cord overlap.

Sites / Locations

  • Memorial Sloan Kettering Basking Ridge (All Protocol Activities)Recruiting
  • Memorial Sloan Kettering Monmouth (All protocol activities)Recruiting
  • Memorial Sloan Kettering Bergen (All protocol activities)Recruiting
  • Memorial Sloan Kettering Commack (All protocol activities)Recruiting
  • Memorial Sloan Kettering Westchester (All Protocol Activities)Recruiting
  • Memorial Sloan Kettering Cancer Center (All Protocol Activities)Recruiting
  • Memorial Sloan Kettering Nassau (All protocol activities)Recruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

radiation

Arm Description

Subjects will receive reduced dose radiation to radiographically progressive lesions identified on imaging (including asymptomatic bone metastases).

Outcomes

Primary Outcome Measures

Treatment failure rate of irradiated lesion
Defined as (i) radiographic progression or (ii) re-irradiation to the treated site. If PET is performed, radiographic criteria will be evaluated per PERCIST

Secondary Outcome Measures

Full Information

First Posted
August 11, 2021
Last Updated
July 6, 2023
Sponsor
Memorial Sloan Kettering Cancer Center
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1. Study Identification

Unique Protocol Identification Number
NCT05010031
Brief Title
A Study of Reduced-dose Radiation in People With Metastatic Tumors With a Genetic Change
Official Title
Phase II Study to Examine Precision Radiation in Patients With Pathogenic Mutations in ATM
Study Type
Interventional

2. Study Status

Record Verification Date
July 2023
Overall Recruitment Status
Recruiting
Study Start Date
August 11, 2021 (Actual)
Primary Completion Date
August 2024 (Anticipated)
Study Completion Date
August 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Memorial Sloan Kettering Cancer Center

4. Oversight

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

5. Study Description

Brief Summary
This study will test whether reduced-dose radiotherapy is an effective treatment for metastatic tumors with an ATM mutation. The researchers want to find the lowest dose of radiation that would still be effective to treat these tumors.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Metastatic Cancer
Keywords
Reduced-dose Radiation, Pathogenic Mutations, ATM (ataxia telangiectasia mutated), 21-310

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Model Description
Single arm, phase II noninferiority, prospective trial
Masking
None (Open Label)
Allocation
N/A
Enrollment
58 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
radiation
Arm Type
Experimental
Arm Description
Subjects will receive reduced dose radiation to radiographically progressive lesions identified on imaging (including asymptomatic bone metastases).
Intervention Type
Radiation
Intervention Name(s)
Palliative radiotherapy
Intervention Description
The first cohort of 26 evaluable patients will be treated with 4Gyx2, followed by a 6 month observation period post-RT to assess for treatment failures. If 7 or more failures are observed, cohort 1 will be closed and 4Gyx3 will be explored in the second cohort. If at most 6 failures are detected in the first cohort, dose will be further reduced to 4Gyx1 for the second cohort. Radiation therapy will be delivered according to department standards, including normal tissue constraints per hypofractionated guidelines. All techniques including conventional, 3D-CRT, or IMRT technique may be used. Image guidance at the time of treatment delivery to verify patient positioning may be chosen at the discretion of the treating radiation oncologist according to department standards.
Primary Outcome Measure Information:
Title
Treatment failure rate of irradiated lesion
Description
Defined as (i) radiographic progression or (ii) re-irradiation to the treated site. If PET is performed, radiographic criteria will be evaluated per PERCIST
Time Frame
6 month

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Histologically confirmed malignancy with at least one metastatic lesion referred for palliative radiotherapy Pathogenic mutation in ATM (somatic and germline allowed) ECOG performance status 0-2 Age ≥ 18 years. Able to provide informed consent. Patients at reproductive potential must agree to practice an effective contraceptive method during radiation treatments. Expected life expectancy of at least 6 months Exclusion Criteria: Previous radiotherapy to the intended treatment site that precludes developing a treatment plan that respects normal tissue tolerances. Serious medical co-morbidities precluding radiotherapy. Pregnant or breast-feeding women. Concomitant pathogenic mutation in p53 Lesions excluded from de-escalation include regions in which the risk of local disease progression is unacceptably high, including CNS disease and cord compression, and areas in which re-irradiation would not be feasible, including spinal cord overlap.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Amy Xu, MD, PhD
Phone
646-888-6863
Email
xua@mskcc.org
First Name & Middle Initial & Last Name or Official Title & Degree
Daniel Gomez, MD
Phone
212-639-2087
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Amy Xu, MD, PhD
Organizational Affiliation
Memorial Sloan Kettering Cancer Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Memorial Sloan Kettering Basking Ridge (All Protocol Activities)
City
Basking Ridge
State/Province
New Jersey
ZIP/Postal Code
10065
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Amy Xu, MD, PhD
Phone
646-888-6863
Facility Name
Memorial Sloan Kettering Monmouth (All protocol activities)
City
Middletown
State/Province
New Jersey
ZIP/Postal Code
07748
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Amy Xu, MD, PhD
Phone
646-888-6863
Facility Name
Memorial Sloan Kettering Bergen (All protocol activities)
City
Montvale
State/Province
New Jersey
ZIP/Postal Code
07645
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Amy Xu, MD, PhD
Phone
646-888-6863
Facility Name
Memorial Sloan Kettering Commack (All protocol activities)
City
Commack
State/Province
New York
ZIP/Postal Code
11725
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Amy Xu, MD, PhD
Phone
646-888-6863
Facility Name
Memorial Sloan Kettering Westchester (All Protocol Activities)
City
Harrison
State/Province
New York
ZIP/Postal Code
10604
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Amy Xu, MD, PhD
Phone
646-888-6863
Facility Name
Memorial Sloan Kettering Cancer Center (All Protocol Activities)
City
New York
State/Province
New York
ZIP/Postal Code
10065
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Amy Xu, MD, PhD
Phone
646-888-6863
First Name & Middle Initial & Last Name & Degree
Daniel Gomez, MD
Phone
212-639-2087
First Name & Middle Initial & Last Name & Degree
Amy Xu, MD, PhD
Facility Name
Memorial Sloan Kettering Nassau (All protocol activities)
City
Uniondale
State/Province
New York
ZIP/Postal Code
11553
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Amy Xu, MD, PhD
Phone
646-888-6863

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
Memorial Sloan Kettering Cancer Center supports the international committee of medical journal editors (ICMJE) and the ethical obligation of responsible sharing of data from clinical trials. The protocol summary, a statistical summary, and informed consent form will be made available on clinicaltrials.gov when required as a condition of Federal awards, other agreements supporting the research and/or as otherwise required. Requests for deidentified individual participant data can be made beginning 12 months after publication and for up to 36 months post publication. Deidentified individual participant data reported in the manuscript will be shared under the terms of a Data Use Agreement and may only be used for approved proposals. Requests may be made to: crdatashare@mskcc.org.
Links:
URL
https://www.mskcc.org/
Description
Memorial Sloan Kettering Cancer Center

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A Study of Reduced-dose Radiation in People With Metastatic Tumors With a Genetic Change

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