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

Yale University

Status and phase: Enrolling; Phase 2; Phase 1

Conditions: Non-small Cell Lung Cancer

Treatments: Radiation: 45 Gray (Gy) regimen

Study type: Interventional

Funder types: Other

Identifiers

NCT04210492

2000025868

Details and patient eligibility

About

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.

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 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.

Enrollment: 36 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. 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.
2. ECOG Performance Status of 0-2
3. Age > 18
4. Patients must sign a study-specific consent form.

Exclusion criteria

1. Prior history of radiotherapy near target lesion resulting in overlapping treatment fields. Previously irradiated will be defined as OAR structures receiving the following doses (in <3Gy 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 > 45Gy
   • Brainstem previously irradiated to > 50 Gy
   • Lung previously irradiated with prior V20Gy > 35%

2. Active systemic, pulmonary, or pericardial infection

3. Interstitial pneumonia or extensive and symptomatic interstitial fibrosis of the lung

4. Pregnant or lactating

5. Any other medical condition or reason that, in the opinion of the investigator, would preclude study participation

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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36 participants in 1 patient group

45 Gy

Experimental group

Description:

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

Treatment:

Radiation: 45 Gray (Gy) regimen