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

Non-small Cell Lung Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04210492
• Other study ID #: 2000025868
• Status: Recruiting
• Phase: Phase 1/Phase 2
• Start date: March 2, 2020
• Est. completion date: January 2030

Study information

• Verified date: July 2023
• Source: Yale University
• Contact: Henry S. Park, MD, MPH
• Phone: 203-200-2100
• Email: henry.park[@]yale.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 36
• Est. completion date: January 2030
• Est. primary completion date: January 2030
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion 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.

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

• May not be pregnant or lactating

• No other medical condition or reason that, in the opinion of the investigator, would preclude study participation

Related Conditions & MeSH terms

• Lung Neoplasms
• Non-small Cell Lung Cancer

Intervention

Radiation:
• 45 Gray (Gy) regimen
Deescalated 3-fraction stereotactic body radiotherapy regimen to 45 Gy in 3 fractions.

Locations

Country	Name	City	State
United States	Smilow Cancer Hospital	New Haven	Connecticut

Sponsors (1)

Lead Sponsor	Collaborator
Yale University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	organ at risk (OAR) dosimetry		Up to 10 years post-enrollment.
Other	quality of life (QOL)	QOL will be measured by the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30). Each item of this 30-item questionnaire is measured on a scale ranging from 1-4, with higher scores signaling lower quality of life. The total possible score is 120. Quality of life will be measured longitudinally, as one outcome. This outcome will be measured at baseline, on the last day of treatment and at 1, 4, 8, and 12 months post-treatment. Thereafter, quality of life will be measured every 6 months, up to 5 years.	baseline and up to 5 years.
Primary	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
Primary	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	lobar control	Absence of primary tumor failure or involved lobe failure or both.	Up to 10 years post-enrollment.
Secondary	regional control	Absence of measurable tumor within lymph nodes along the natural lymphatic drainage typical for the location of the treated primary disease only with dimension of at least 1.0 cm on imaging studies (preferably computer tomography scans) within the lung, bronchial hilum, or the mediastinum.	Up to 10 years post-enrollment.
Secondary	distant control		Up to 10 years post-enrollment.
Secondary	overall survival		Up to 10 years post-enrollment.
Secondary	progression-free survival		Up to 10 years post-enrollment.