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

NCT ID: NCT04210492

Last Updated: 2025-05-14

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

PHASE1/PHASE2

Total Enrollment

36 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-08-26

Study Completion Date

2030-01-31

Brief Summary

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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

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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.

Conditions

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Non-small Cell Lung Cancer

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

The intervention group will be compared with historical controls.
Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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45 Gy

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

Group Type EXPERIMENTAL

45 Gray (Gy) regimen

Intervention Type RADIATION

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

Interventions

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45 Gray (Gy) regimen

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

Intervention Type RADIATION

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Yale University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Henry S. Park, MD, MPH

Role: PRINCIPAL_INVESTIGATOR

Yale University

Locations

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Smilow Cancer Hospital Care Center at Greenwich

Greenwich, Connecticut, United States

Site Status RECRUITING

Smilow Cancer Hospital Care Center - Guilford

Guilford, Connecticut, United States

Site Status RECRUITING

Smilow Cancer Hospital - Hamden Care Center

Hamden, Connecticut, United States

Site Status RECRUITING

Smilow Cancer Hospital

New Haven, Connecticut, United States

Site Status RECRUITING

Smilow Cancer Hospital Care Center - Trumbull

Trumbull, Connecticut, United States

Site Status RECRUITING

Smilow Cancer Hospital Care Center - Waterford

Waterford, Connecticut, United States

Site Status RECRUITING

Countries

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United States

Central Contacts

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Henry S. Park, MD, MPH

Role: CONTACT

203-200-2100

Facility Contacts

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Jennifer Pope

Role: primary

203-494-3732

Jennifer Pope

Role: primary

203-494-3732

Jennifer Pope

Role: primary

203-494-3732

Jennifer Pope

Role: primary

203) 494-3732

Jennifer Pope

Role: primary

203-494-3732

Jennifer Pope

Role: primary

203-494-3732

Other Identifiers

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2000025868

Identifier Type: -

Identifier Source: org_study_id

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