IR-guided Ablation (IRGA) Combined With Stereotactic Ablative Radiation (SABR) for Large Lung Tumors

Stopped early · Phase 1

Conditions studied: Recurrent Non-small Cell Lung Cancer

In brief

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.

Key facts

Study ID

NCT01746810

Run by

New Mexico Cancer Research Alliance

People needed

1

Starts

2012-07-01

Expected to finish

2015-10-13

Last updated by the study team

2017-11-17

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• University of New Mexico Cancer Center — Albuquerque, New Mexico, United States

Full record on ClinicalTrials.gov

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