Clinical trial NCT01746810: IR-guided Ablation (IRGA) Combined With Stereotactic Ablative Radiation (SABR) for Large Lung Tumors
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
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE1
Conditions: Recurrent Non-small Cell Lung Cancer
Keywords: Metastatic
Lung Cancer
NSCLC
Lead sponsor: New Mexico Cancer Research Alliance
Sponsor class: OTHER
First posted: 2012-12-11
Enrollment: 1
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: 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.

Detailed 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.

Eligibility criteria: 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

Primary outcomes:
measure: Maximum Tolerated Dose (MTD)
timeFrame: 30 to 90 days
Secondary outcomes:
measure: Survival
timeFrame: Up to 6 years
measure: Biomarker testing
timeFrame: 2 weeks
measure: Pathological Response
timeFrame: Up to 6 years
measure: Quality of Life
timeFrame: Up to 6 years
Other outcomes:
Locations:
city: Albuquerque
country: United States
facility: University of New Mexico Cancer Center
state: New Mexico
Study officials:
affiliation: UNM Cancer Center
name: Thomas Schroeder, MD
role: PRINCIPAL_INVESTIGATOR
References: