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SBRT for Ultra-Central NonSmall Cell Lung Cancer

ConditionNonsmall Cell Lung Cancer Stage
Trial statusNot yet recruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18+
SponsorGeorgetown University

About this trial

The goal of this clinical trial is to find out if Five-fraction CyberKnife stereotactic body radiation therapy (SBRT) with real-time Synchrony® motion tracking can treat ultra-central nonsmall cell lung cancer while reducing the amount of serious side effects from SBRT. Participants will

* receive radiation treatment every other day over two weeks using a machine called the CyberKnife®, which uses a technology called Synchrony® motion management, which tracks your tumor in real time as it moves with your breathing. This allows the radiation beam to follow your tumor during treatment, helping to deliver the radiation more accurately to the tumor while reducing the dose to nearby healthy organs. * return for follow up visits after treatment at months 3, 6, 9, 12, 18, 24 and then every year for 5 years to be evaluated * complete questionnaires before and after treatment.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Patients aged 18 or older.

Patients with an Eastern Cooperative Oncology Group (ECOG) performance status of 0-2.

Patients with confirmed tumor location using advanced imaging to ensure accurate classification of ultra-central NSCLC.

Ability to undergo bronchoscopy and Endobronchial ultrasound (EBUS) with adequate fiducial placement

Disqualifiers

Patients with evidence of nodal involvement (N1-N3) or distant metastases (M1).

Patients with previous radiation therapy to the thorax that would result in overlap with the planned treatment field.

Patients with tumor-associated bronchial compression, defined as visible deformation or narrowing of the trachea, mainstem bronchus, or bronchus intermedius on diagnostic CT, simulation CT, or bronchoscopy.

Patients receiving concurrent chemotherapy, immunotherapy, or targeted therapy during SBRT.

Trial design

Design model

Single group

Treatments tested in this trial

  • SBRT

    Radiation

    50 Grays (Gy) delivered in 5 fractions, delivered using Cyberknife with Synchrony motion tracking, every other day over 2 weeks.

Treatment groups

35 Participants
are divided into 1 treatment group
Group A: Cyberknife with Synchrony Motion TrackingExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Cumulative incidence of grade 3 or higher toxicity following SBRT with CyberKnife regimen with real-time motion tracking for ultra-central NSCLC.

The primary safety endpoint is the cumulative incidence of acute or late grade ≥3 AEs occurring within 12 months and assessed as possibly, probably, or definitely related to protocol treatment. AEs will be graded using the NCI CTCAE version 6.0. Prespecified thoracic AEs include dyspnea, cough, pneumonitis, lung infection, atelectasis, bronchial stenosis or obstruction, bronchopulmonary hemorrhage or hemoptysis, fistula, dysphagia or esophagitis, pleural or pericardial effusion, and chest pain.

Time frame
Patients will be assessed for toxicity throughout treatment with radiation therapy (RT). Following RT, all participants will be evaluated through 12 months for the primary safety endpoint and will continue protocol safety follow-up through 5 years.

Secondary outcomes

1

Local control (LC)

LC will be calculated using the cumulative incidence method and reported along with a 95% exact binomial confidence interval (CI).

Time frame
Until Trial Completed (up to 5 years)
2

Regional nodal progression

The regional nodal progression is defined as the length of time from radiation completion of the first documented presence of enlarged lymph nodes \>1 cm \[short axis\] in the hilum or mediastinum and biopsy confirmed. The Kaplan-Meier method will be used for the analyses, and the median regional nodal progression free time with 95% CI will be reported, respectively, if available.

Time frame
Until Trial Completed (up to 5 years)
3

Distant metastasis-free survival (DMFS)

DMFS is defined as the length of time, from radiation completion to the first evidence of clinical distant metastatic spread of NSCLC outside of the lung cavity or death, whichever occurs first. Patients who are alive and free from clinical distant metastasis will be censored at the date of last follow-up for DMFS. The Kaplan-Meier method will be used for the analyses, and the median DMFS with 95% CI will be reported, respectively, if available.

Time frame
Until trial completed (up to 5 years)
4

Progression-free survival (PFS)

PFS is defined as the length of time, from radiation completion to the first evidence of clinical/radiographic progression, biopsy confirmation when feasible, distant metastasis, or death, whichever comes first. Patients who are alive and free from disease progression will be censored at the date of last follow-up or date of death, whichever occurs first. SOC PET/CT imaging results will be reviewed and collected. The Kaplan-Meier method will be used for the analyses, and the median PFS with 95% CI will be reported, respectively, if available.

Time frame
From baseline through the follow up period at 3, 6, 9, 12, 18, 24 months followed annually thereafter up to 5 years.

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Georgetown University

Lead sponsor

Accuray Incorporated

Collaborator

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: