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Dose-Deescalated 3-Fraction Stereotactic Body Radiotherapy For Centrally Located Lung Cancer

Primary Purpose

Non-small Cell Lung Cancer

Status
Recruiting
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
45 Gray (Gy) regimen
Sponsored by
Yale University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Non-small Cell Lung Cancer

Eligibility Criteria

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

Inclusion Criteria:

  • Tumors will be ≤ 5 cm and centrally located, meaning any portion of gross tumor volume located within 2 cm of (but not abutting) the proximal bronchial tree (trachea, carina, right and left main bronchi, right and left upper lobe bronchi, bronchus intermedius, right middle lobe bronchus, lingular bronchus, right and left lower lobe bronchi), or within 2 cm of (whether abutting or not) major vessels, esophagus, or heart (based on Radiation Therapy Oncology Group (RTOG) and MD Anderson Cancer Center definitions). The principal investigator (PI) will review and prospectively approve any lesions abutting these organs.
  • Only one isocenter may be used during the treatment course. This may include separate tumor
  • ECOG Performance Status of 0-2
  • Age > 18
  • Patients must sign a study-specific consent form.

Exclusion Criteria:

  • prior history of radiotherapy near target lesion resulting in overlapping treatment fields. Previously irradiated will be defined as organ at risk (OAR) structures in the receiving the following doses ( in <3 Gray (Gy) per fraction): Spinal cord previously irradiated to > 40 Gy, Brachial plexus previously irradiated to > 50 Gy, Small intestine, large intestine, or stomach previously irradiated to > 45 Gy, Brainstem previously irradiated to > 50 Gy, Lung previously irradiated with prior V20Gy > 35%.
  • No active systemic, pulmonary, or pericardial infection
  • No interstitial pneumonia or extensive and symptomatic interstitial fibrosis of the lung
  • No significant cardiac disease, including the following: unstable angina, New York Heart Association class II-IV congestive heart failure, myocardial infarction within six months prior to study enrollment
  • No plan for the patient to receive other concomitant antineoplastic treatment (including chemotherapy, biological therapy, vaccine therapy, and surgery)
  • May not be pregnant or lactating
  • No history of SARS-CoV-2 diagnosis or presumed diagnosis in the previous 3 months
  • No other medical condition or reason that, in the opinion of the investigator, would preclude study participation

Sites / Locations

  • Smilow Cancer HospitalRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

45 Gy

Arm Description

Deescalated 3-fraction stereotactic body radiotherapy regimen to 45 Gy in 3 fractions.

Outcomes

Primary Outcome Measures

Safety of the stereotactic body radiotherapy regimen (SBRT)
Safety will be assessed by acute (defined as within 90 days of stereotactic body radiotherapy (SBRT)) and late (from 91 days through 2 years post-SBRT) toxicities. Toxicities are based on (Common Terminology Criteria for adverse events) CTCAE v. 5 criteria
local control (LC) of 3-fraction stereotactic body radiotherapy
The absence of primary tumor failure. Primary tumor failure is defined as Increase in tumor dimension of 20%.

Secondary Outcome Measures

lobar control
Absence of primary tumor failure or involved lobe failure or both.
regional control
Absence of measurable tumor within lymph nodes along the natural lymphatic drainage typical for the location of the treated primary disease only with dimension of at least 1.0 cm on imaging studies (preferably computer tomography scans) within the lung, bronchial hilum, or the mediastinum.
distant control
overall survival
progression-free survival

Full Information

First Posted
December 10, 2019
Last Updated
July 13, 2023
Sponsor
Yale University
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1. Study Identification

Unique Protocol Identification Number
NCT04210492
Brief Title
Dose-Deescalated 3-Fraction Stereotactic Body Radiotherapy For Centrally Located Lung Cancer
Official Title
Phase IB/II Trial Of Dose-Deescalated 3-Fraction Stereotactic Body Radiotherapy For Centrally Located Lung Cancer
Study Type
Interventional

2. Study Status

Record Verification Date
July 2023
Overall Recruitment Status
Recruiting
Study Start Date
March 2, 2020 (Actual)
Primary Completion Date
January 2030 (Anticipated)
Study Completion Date
January 2030 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Yale University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
The purpose of this trial is to test a deescalated 3-fraction stereotactic body radiotherapy (SBRT) regimen to 45 Gray (Gy) in 3 fractions for centrally located thoracic tumors.
Detailed Description
The purpose of this trial is to test a deescalated 3-fraction SBRT regimen to 45 Gy in 3 fractions for centrally located thoracic tumors in a phase II trial. This will provide prospectively collected data on the safety and efficacy of a three-fraction regimen in the previously defined "No Fly Zone" for both primary non-small cell lung cancer (NSCLC) and for lung metastases of any histology. This registration describes the design and eligibility criteria for the 36 NSCLC subjects the investigators plan to enroll. Local control, cancer-specific survival, and overall survival results from the NSCLC patients will be compared to both 3- and 5-fraction historical controls, specifically RTOG 0236 and 0813 results. The outcomes of the metastatic patients will also be reported. There will also be a quality-of-life component to the study to assess the impact of a shorter overall treatment time and the clinical impact of radiation side effects.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Non-small Cell Lung Cancer

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Interventional Study Model
Single Group Assignment
Model Description
The intervention group will be compared with historical controls.
Masking
None (Open Label)
Allocation
N/A
Enrollment
36 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
45 Gy
Arm Type
Experimental
Arm Description
Deescalated 3-fraction stereotactic body radiotherapy regimen to 45 Gy in 3 fractions.
Intervention Type
Radiation
Intervention Name(s)
45 Gray (Gy) regimen
Intervention Description
Deescalated 3-fraction stereotactic body radiotherapy regimen to 45 Gy in 3 fractions.
Primary Outcome Measure Information:
Title
Safety of the stereotactic body radiotherapy regimen (SBRT)
Description
Safety will be assessed by acute (defined as within 90 days of stereotactic body radiotherapy (SBRT)) and late (from 91 days through 2 years post-SBRT) toxicities. Toxicities are based on (Common Terminology Criteria for adverse events) CTCAE v. 5 criteria
Time Frame
From administration of SBRT up to 2 years post-SBRT
Title
local control (LC) of 3-fraction stereotactic body radiotherapy
Description
The absence of primary tumor failure. Primary tumor failure is defined as Increase in tumor dimension of 20%.
Time Frame
Up to 10 years post-enrollment.
Secondary Outcome Measure Information:
Title
lobar control
Description
Absence of primary tumor failure or involved lobe failure or both.
Time Frame
Up to 10 years post-enrollment.
Title
regional control
Description
Absence of measurable tumor within lymph nodes along the natural lymphatic drainage typical for the location of the treated primary disease only with dimension of at least 1.0 cm on imaging studies (preferably computer tomography scans) within the lung, bronchial hilum, or the mediastinum.
Time Frame
Up to 10 years post-enrollment.
Title
distant control
Time Frame
Up to 10 years post-enrollment.
Title
overall survival
Time Frame
Up to 10 years post-enrollment.
Title
progression-free survival
Time Frame
Up to 10 years post-enrollment.
Other Pre-specified Outcome Measures:
Title
organ at risk (OAR) dosimetry
Time Frame
Up to 10 years post-enrollment.
Title
quality of life (QOL)
Description
QOL will be measured by the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30). Each item of this 30-item questionnaire is measured on a scale ranging from 1-4, with higher scores signaling lower quality of life. The total possible score is 120. Quality of life will be measured longitudinally, as one outcome. This outcome will be measured at baseline, on the last day of treatment and at 1, 4, 8, and 12 months post-treatment. Thereafter, quality of life will be measured every 6 months, up to 5 years.
Time Frame
baseline and up to 5 years.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Lung tumors will be ≤ 5 cm and centrally located, meaning any portion of gross tumor volume located within 2 cm of (but not abutting) the proximal bronchial tree (trachea, carina, right and left main bronchi, right and left upper lobe bronchi, bronchus intermedius, right middle lobe bronchus, lingular bronchus, right and left lower lobe bronchi), or within 2 cm of (whether abutting or not) major vessels, esophagus, or heart (based on RTOG and MD Anderson Cancer Center definitions 33,34). Multiple concurrent isocenters are allowed if at least one tumor meets the above criteria, and if all dose constraints for the plan summation can be met. These concurrent tumors other than study target lesion can be treated as per SOC and does not necessarily have to meet the above size limit. The PI will review and prospectively approve any lesions abutting these organs ECOG Performance Status of 0-2 Age > 18 Patients must sign a study-specific consent form. Exclusion Criteria: prior history of radiotherapy near target lesion resulting in overlapping treatment fields. Previously irradiated will be defined as organ at risk (OAR) structures in the receiving the following doses ( in <3 Gray (Gy) per fraction): Spinal cord previously irradiated to > 40 Gy, Brachial plexus previously irradiated to > 50 Gy, Small intestine, large intestine, or stomach previously irradiated to > 45 Gy, Brainstem previously irradiated to > 50 Gy, Lung previously irradiated with prior V20Gy > 35%. No active systemic, pulmonary, or pericardial infection No interstitial pneumonia or extensive and symptomatic interstitial fibrosis of the lung No significant cardiac disease, including the following: unstable angina, New York Heart Association class II-IV congestive heart failure, myocardial infarction within six months prior to study enrollment May not be pregnant or lactating No other medical condition or reason that, in the opinion of the investigator, would preclude study participation
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Henry S. Park, MD, MPH
Phone
203-200-2100
Email
henry.park@yale.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Henry S. Park, MD, MPH
Organizational Affiliation
Yale University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Smilow Cancer Hospital
City
New Haven
State/Province
Connecticut
ZIP/Postal Code
06511
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Kwasi Boateng
Phone
203-314-7948
Email
kwasi.boateng@yale.edu

12. IPD Sharing Statement

Plan to Share IPD
No

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Dose-Deescalated 3-Fraction Stereotactic Body Radiotherapy For Centrally Located Lung Cancer

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