Lung Cancer Clinical Trial

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

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.

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Full 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 60 NSLCsubjects 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.

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Eligibility Criteria

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

Study is for people with:

Lung Cancer

Phase:

Phase 1

Estimated Enrollment:

60

Study ID:

NCT04210492

Recruitment Status:

Recruiting

Sponsor:

Yale University

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There is 1 Location for this study

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Smilow Cancer Hospital
New Haven Connecticut, 06511, United States More Info
Kwasi Boateng
Contact
203-314-7948
[email protected]

How clear is this clinincal trial information?

Study is for people with:

Lung Cancer

Phase:

Phase 1

Estimated Enrollment:

60

Study ID:

NCT04210492

Recruitment Status:

Recruiting

Sponsor:


Yale University

How clear is this clinincal trial information?

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