Bronchoscopic Laser Ablation of Solid Peripheral Lung Tumors Followed by Surgical Resection (BLAST-SR Trial)
Phase: NA
Conditions: Lung Carcinoid Tumor, Lung Non-Small Cell Carcinoma, Metastatic Lung Carcinoma, Stage IV Lung Cancer AJCC v8, Stage IVA Lung Cancer AJCC v8, Stage IVB Lung Cancer AJCC v8
Sponsor: M.D. Anderson Cancer Center

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Bronchoscopic Laser Ablation of Solid Peripheral Lung Tumors 
followed by Surgical Resection (BLAST-SR Trial) 
 
Background and Rationale 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

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Study Objectives 
 
Primary objective 
1. To assess the pathologic changes that result from bronchoscopic laser ablation of 
peripheral lung tumors focusing on the degree of tumor ablation which will be 
categorized as complete, quasi-complete, or incomplete. 
 
Secondary Objectives 
2a. To assess the safety of this technique by describing both procedure-related 
complications such as bleeding or pneumothorax and post-procedure adverse effects 
such as fever or pneumonitis. 
2b. To assess the pathologic changes observed in the lung tissue surrounding the 
treated lung tumor.  
2c. To assess radiographic changes observed by cone-beam CT immediately after the 
application of bronchoscopic laser ablation. 
 
DESIGN AND PROCEDURE 
 
Overall Study Description 
 
 
 
 
 
 
 
 
 
 

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Study Design 
 
This is a prospective observational pilot study in which patients with peripheral 
lung tumors will undergo bronchoscopic laser ablation followed by surgical resection 
and pathologic evaluation of ablative changes. 
 
 
Study Setting 
 
The University of Texas MD Anderson Cancer Center. 
 
Study Population 
Inclusion Criteria: 
- 
Written informed consent  
- 
Performance status 0-2 (Eastern Cooperative Oncology Group classification) 
- 
≥ 18 years old 
- 
Subject is considered a candidate for bronchoscopy 
- 
Subject is considered a candidate for surgery (either lobar or sub-lobar resection) 
based on radiographic staging and functional evaluation 

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- 
Lung lesion that is either biopsy-proven cancer or is suspicious for cancer 
- 
Both non-small cell lung cancer (including carcinoid tumors) and metastatic 
disease 
- 
The lesions should be: ≤ 3 cm, located in the outer 2/3 of the lung, and leave ≥1 
cm of tumor-free lung parenchyma between target tumor and pleura or fissure 
Exclusion Criteria: 
- 
Tumors greater than 3 cm, located in the inner 1/3 of the lung, invading a major 
vessel, or located < 1 cm from the pleural or fissure 
- 
Tumors qualified as non-resectable 
- 
Tumors that cannot be reached bronchoscopically 
- 
Patients declared non-surgical candidates 
- 
Patients who are not candidates for bronchoscopy 
- 
Patients with lung cancer who are found to have N2-3 disease 
- 
Patient with lung metastases who are found to have any malignant mediastinal 
lymph node 
- 
Patients in which the target lesion is confirmed as benign or small cell lung 
cancer 
- 
Patients without a prior diagnosis of the target lesion whose diagnosis cannot be 
made during bronchoscopy 
- 
Patients who have received chemotherapy within 60 days prior to bronchoscopic 
laser ablation 
- 
Patients who were previously treated for the target lesion 
- 
Pregnant patients 
 
 
 
 
 
 
 
 

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We will conduct extensive descriptive analyses of the data collected. We will 
calculate the appropriate summary statistics and 90% confidence intervals (CIs) for the 
measures of interest described in primary and secondary objectives. For example, we 
will obtain frequencies and proportions of the three tumor ablation outcome categories 
(complete, quasi-complete, and incomplete) for the primary objective, and record the 
number of each type of SAE at each level of laser power. Our goal is to simply assess 
the magnitude and obtain preliminary estimates of this technique to proceed to our next 
project which is the development of a large multicenter randomized trial comparing the 
effectiveness of this new bronchoscopic laser ablative technique vs. the standard of 
care for these patients, SBRT, in patients with medically inoperable early lung cancer. 
 
Sample Size Justification. This is a pilot trial to assess whether a new technique can be 
delivered safely to humans and provide complete ablation of lung tumors, and is not 
powered for significance in statistical comparison as there is insufficient existing 
evidence to predict the likely outcomes. A total of 15 patients will be recruited from UT 
MD Anderson Cancer Center. With this sample size, the 90% confidence interval for an 
expected 70% of complete ablation rate can be estimated with a maximum width of 
0.195. This power was based on nQuery Advisor. 
 
Toxicity Monitoring 
 
We will monitor patients for unacceptable toxicity in cohorts of size 5 [11].  An 
unacceptable toxicity in this study is defined as pneumothorax requiring chest tube, 
bleeding requiring balloon tamponade or leading to respiratory failure, and hypoxemia 
(SpaO2 <90% for > 1 min) during bronchoscopy, post-bronchoscopy pneumonitis with 
need of supplemental oxygen. 
 
If we find Pr[πT > 0.3 | data] > 0.85, where πT is the true proportion of patients who 
experience unacceptable toxicities and follows a beta(0.6, 1.4) distribution, we will stop 
the trial for toxicity.     
 

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The stopping boundaries for toxicity are found in Table 1. Table 2 shows the operating 
characteristics for this design. The stopping boundaries and operating characteristics 
were created based upon 1,000 simulations using Multc Lean Desktop V2.1. 
 
Other Considerations 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

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