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

NCT04210492 | Recruiting Phase 1 DMC

• 1 other identifier: 2000025868
• Study Type: interventional
• Target: 36
• Locations: 1 country
• Sites: 6

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.

Conditions

Non-small Cell Lung Cancer

Outcome Measures

Primary Outcomes (2)

• 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

  From administration of SBRT up to 2 years post-SBRT

• 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%.

  Up to 10 years post-enrollment.

Secondary Outcomes (5)

• lobar control

  Up to 10 years post-enrollment.

• regional control

  Up to 10 years post-enrollment.

• distant control

  Up to 10 years post-enrollment.

• overall survival

  Up to 10 years post-enrollment.

• progression-free survival

  Up to 10 years post-enrollment.

Other Outcomes (2)

• organ at risk (OAR) dosimetry

  Up to 10 years post-enrollment.

• quality of life (QOL)

  baseline and up to 5 years.

Study Arms (1)

45 Gy

EXPERIMENTAL

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

Radiation: 45 Gray (Gy) regimen

Interventions

45 Gray (Gy) regimen RADIATION

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

45 Gy

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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%
• Active systemic, pulmonary, or pericardial infection
• Interstitial pneumonia or extensive and symptomatic interstitial fibrosis of the lung
• Pregnant or lactating
• Any other medical condition or reason that, in the opinion of the investigator, would preclude study participation

Sponsors & Collaborators

• Yale University: lead

Study Sites (6)

Smilow Cancer Hospital Care Center at Greenwich

Greenwich, Connecticut, 06830, United States

RECRUITING

Smilow Cancer Hospital Care Center - Guilford

Guilford, Connecticut, 06437, United States

RECRUITING

Smilow Cancer Hospital - Hamden Care Center

Hamden, Connecticut, 06518, United States

RECRUITING

Smilow Cancer Hospital

New Haven, Connecticut, 06511, United States

RECRUITING

Smilow Cancer Hospital Care Center - Trumbull

Trumbull, Connecticut, 06611, United States

RECRUITING

Smilow Cancer Hospital Care Center - Waterford

Waterford, Connecticut, 06385, United States

RECRUITING

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell Lung

Interventions

Clinical Protocols

Condition Hierarchy (Ancestors)

Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Therapeutics; Epidemiologic Study Characteristics; Health Care Evaluation Mechanisms; Quality of Health Care; Health Care Quality, Access, and Evaluation

Study Officials

• Henry S. Park, MD, MPH

  Yale University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Henry S. Park, MD, MPH

CONTACT

203-200-2100; henry.park@yale.edu

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: The intervention group will be compared with historical controls.

Study Record Dates

• First Submitted: December 10, 2019
• First Posted: December 24, 2019
• Study Start: August 26, 2020
• Primary Completion (Estimated): January 1, 2030
• Study Completion (Estimated): January 1, 2030
• Last Updated: May 14, 2025

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (6)