This trial is active, not recruiting.

Condition recurrent non-small cell lung cancer
Treatment stereotactic body rt and irga
Phase phase 1
Sponsor New Mexico Cancer Care Alliance
Start date July 2012
End date November 2013
Trial size 12 participants
Trial identifier NCT01746810, INST 1206


This phase I trial studies the side effects and best dose of stereotactic body radiation therapy when given together with ablation therapy in treating patients with non-small cell lung cancer or lung metastases. Ablation therapy, such as radiofrequency ablation uses a high-frequency, electric current to kill tumor cells. Ablation therapy, such as microwave ablation kills tumor cells by heating them to several degrees above normal body temperature. Stereotactic body radiation therapy may be able to send x-rays directly to the tumor and cause less damage to normal tissue. Giving ablation therapy together with stereotactic body radiation therapy may kill more tumor cells.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Endpoint classification safety/efficacy study
Intervention model single group assignment
Masking open label
Primary purpose treatment
Patients undergo stereotactic body radiation therapy QD for a total of 5 fractions and then undergo IRGA (either radiofrequency ablation or microwave ablation) 1 week later.
stereotactic body rt and irga Radiofrequency ablation
SABR Treatment with Dose escalation: Group 1: 40 Gy/5 fractions Group 2: 45 Gy/5 fractions Group 3: 50 Gy/5 fractions then IRGA procedure 1 week later with repeat lung biopsies, serum studies

Primary Outcomes

Maximum Tolerated Dose (MTD)
time frame: 30 to 90 days

Secondary Outcomes

time frame: Up to 6 years
Biomarker testing
time frame: 2 weeks
Pathological Response
time frame: Up to 6 years
Quality of Life
time frame: Up to 6 years

Eligibility Criteria

Male or female participants at least 18 years old.

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 consultation - 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 eligibility - 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 evaluation - International normalization ratio (INR) of > 1.5 - Platelets of < 50,000 /uL - Inability to meet maximum point dose constraints

Additional Information

Official title 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
Principal investigator Thomas Schroeder, MD
Description 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.
Trial information was received from ClinicalTrials.gov and was last updated in June 2016.
Information provided to ClinicalTrials.gov by New Mexico Cancer Care Alliance.