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RecruitingInterventionalPhase 1/Phase 2

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

NCT ID: NCT04210492Sponsor: Yale UniversityLast updated: 2026-06-17

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.

Arms & interventions

  • Radiation45 Gray (Gy) regimen

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

Outcome measures

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

    Time frame: 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%.

    Time frame: Up to 10 years post-enrollment.

Secondary

  • lobar control

    Time frame: Up to 10 years post-enrollment.

  • regional control

    Time frame: Up to 10 years post-enrollment.

  • distant control

    Time frame: Up to 10 years post-enrollment.

  • overall survival

    Time frame: Up to 10 years post-enrollment.

  • progression-free survival

    Time frame: Up to 10 years post-enrollment.

Eligibility criteria

Sex: AllAge: 18 Years and olderHealthy volunteers: No
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

Study locations (6)

Smilow Cancer Hospital Care Center at Greenwich

Greenwich, Connecticut, 06830

Recruiting
Jennifer Pope · Contact

Smilow Cancer Hospital Care Center - Guilford

Guilford, Connecticut, 06437

Recruiting
Jennifer Pope · Contact

Smilow Cancer Hospital - Hamden Care Center

Hamden, Connecticut, 06518

Recruiting
Jennifer Pope · Contact

Smilow Cancer Hospital

New Haven, Connecticut, 06511

Recruiting
Jennifer Pope · Contact

Smilow Cancer Hospital Care Center - Trumbull

Trumbull, Connecticut, 06611

Recruiting
Jennifer Pope · Contact

Smilow Cancer Hospital Care Center - Waterford

Waterford, Connecticut, 06385

Recruiting
Jennifer Pope · Contact