RECRUITING

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

Conditions

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

Phase IB/II Trial Of Dose-Deescalated 3-Fraction Stereotactic Body Radiotherapy For Centrally Located Lung Cancer

Quick Facts

Study Start:2020-03-02

Study Completion:2030-01

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT04210492

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion 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.	* 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

Inclusion Criteria

Exclusion 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.

* 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

Contacts and Locations

Study Contact

Henry S. Park, MD, MPH

CONTACT

203-200-2100

henry.park@yale.edu

Principal Investigator

Henry S. Park, MD, MPH

PRINCIPAL_INVESTIGATOR

Yale University

Study Locations (Sites)

Smilow Cancer Hospital

New Haven, Connecticut, 06511

United States

Collaborators and Investigators

Sponsor: Yale University

Henry S. Park, MD, MPH, PRINCIPAL_INVESTIGATOR, Yale University

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2020-03-02

Study Completion Date2030-01

Study Record Updates

Study Start Date2020-03-02

Study Completion Date2030-01

Terms related to this study

Additional Relevant MeSH Terms

Non-small Cell Lung Cancer