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IR-guided Ablation (IRGA) Combined With Stereotactic Ablative Radiation (SABR) for Lung Tumors Larger Than 3 cm: Phase I Dose Escalation and Pilot Study With Companion Biomarker Analysis

18 Years
Open (Enrolling)
Recurrent Non-small Cell Lung Cancer

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Trial Information

IR-guided Ablation (IRGA) Combined With Stereotactic Ablative Radiation (SABR) for Lung Tumors Larger Than 3 cm: Phase I Dose Escalation and Pilot Study With Companion Biomarker Analysis

This is a dose-escalation study of stereotactic body radiation therapy.

Patients undergo stereotactic body radiation therapy once daily (QD) for a total of 5
fractions and then undergo IRGA (either radiofrequency ablation or microwave ablation) 1
week later.

After completion of study treatment, patients are followed up at 4 weeks, every 3 months for
1 year, every 4 months for 1 year, every 6 months for 3 years, and then annually thereafter.

Inclusion Criteria:

- Pathological (histologically or cytologically) diagnosis of non-small cell lung
cancer (NSCLC); or if lung tumor is considered to be metastases (even from primary
NSCLC), then clinical diagnosis is sufficient

- For NSCLC: Staging workup at initial diagnosis demonstrates T2-T4N0M0, or
T2-T4,N1-3,M1; node-positive patients will be allowed on study only if they have M1
disease; clinical diagnosis of M1 disease is sufficient

- Patient is deemed (a) to be medically inoperable after evaluation by thoracic surgeon
based on, but not limited to the following: baseline forced expiratory volume in one
second (FEV1) < 40% predicted, post-operative FEV1 < 30% predicted, severely reduced
diffusion capacity, baseline hypoxemia/hypercapnia, coronary artery disease,
end-organ damage, or (b): patient has refused surgery after thoracic surgery

- Eastern Cooperative Oncology Group (ECOG) performance status 0-2

- NSCLC only: pleural effusion, if present, will undergo routine assessment for
malignancy; inability to obtain fluid or non-diagnostic cytology will not preclude

- Negative serum or urine pregnancy test within 4 weeks prior to registration in women
with childbearing potential

- Able to provide written, informed consent

- Minimum of 4 weeks from last dose of chemotherapy to start of treatment

Exclusion Criteria:

- For NSCLC only: prior invasive malignancy (except non-melanoma skin cancer) unless
disease-free for a minimum of 2 years, including previous history of lung cancer

- Prior radiation to the region of current cancer that would result in > 50% overlap of
the old treatment field on the new treatment area based on radiation oncologist

- International normalization ratio (INR) of > 1.5

- Platelets of < 50,000 /uL

- Inability to meet maximum point dose constraints

Type of Study:


Study Design:

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Maximum Tolerated Dose (MTD)

Outcome Description:

The MTD will be defined as the highest dose level where less than or equal to 33% patients incurred a dose-limiting toxicity (DLT). A DLT will be defined as an acute (within 30 days) or subacute (31-90 days) irreversible grade 3 or any grade 4-5 toxicity (using National Cancer Institute [NCI]-Common Toxicity Criteria [CTC] version 4.0 criteria) that is possibly, probably, and definitely attributed to the therapy.

Outcome Time Frame:

30 to 90 days

Safety Issue:


Principal Investigator

Thomas Schroeder, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

UNM Cancer Center


United States: Institutional Review Board

Study ID:

INST 1206



Start Date:

July 2012

Completion Date:

July 2019

Related Keywords:

  • Recurrent Non-Small Cell Lung Cancer
  • Metastatic
  • Lung Cancer
  • Carcinoma, Non-Small-Cell Lung
  • Lung Neoplasms



University of New Mexico Cancer CenterAlbuquerque, New Mexico  87131-5636