Clinical trial NCT04210492: Dose-Deescalated 3-Fraction Stereotactic Body Radiotherapy For Centrally Located Lung Cancer
Official title: Phase IB/II Trial Of Dose-Deescalated 3-Fraction Stereotactic Body Radiotherapy For Centrally Located Lung Cancer
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE1
PHASE2
Conditions: Non-small Cell Lung Cancer
Lead sponsor: Yale University
Sponsor class: OTHER
First posted: 2019-12-24
Enrollment: 36
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: The intervention group will be compared with historical controls.
Primary purpose: TREATMENT

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.

Detailed 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.

Eligibility criteria: 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

Primary outcomes:
measure: Safety of the stereotactic body radiotherapy regimen (SBRT)
timeFrame: From administration of SBRT up to 2 years post-SBRT
measure: local control (LC) of 3-fraction stereotactic body radiotherapy
timeFrame: Up to 10 years post-enrollment.
Secondary outcomes:
measure: lobar control
timeFrame: Up to 10 years post-enrollment.
measure: regional control
timeFrame: Up to 10 years post-enrollment.
measure: distant control
timeFrame: Up to 10 years post-enrollment.
measure: overall survival
timeFrame: Up to 10 years post-enrollment.
measure: progression-free survival
timeFrame: Up to 10 years post-enrollment.
Other outcomes:
measure: organ at risk (OAR) dosimetry
timeFrame: Up to 10 years post-enrollment.
measure: quality of life (QOL)
timeFrame: baseline and up to 5 years.
Locations:
city: Greenwich
country: United States
facility: Smilow Cancer Hospital Care Center at Greenwich
state: Connecticut
city: Guilford
country: United States
facility: Smilow Cancer Hospital Care Center - Guilford
state: Connecticut
city: Hamden
country: United States
facility: Smilow Cancer Hospital - Hamden Care Center
state: Connecticut
city: New Haven
country: United States
facility: Smilow Cancer Hospital
state: Connecticut
city: Trumbull
country: United States
facility: Smilow Cancer Hospital Care Center - Trumbull
state: Connecticut
city: Waterford
country: United States
facility: Smilow Cancer Hospital Care Center - Waterford
state: Connecticut
Study officials:
affiliation: Yale University
name: Henry S. Park, MD, MPH
role: PRINCIPAL_INVESTIGATOR
References: