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

This study is currently recruiting participants. (see Contacts and Locations)
Verified April 2014 by New Mexico Cancer Care Alliance
Sponsor:
Information provided by (Responsible Party):
New Mexico Cancer Care Alliance
ClinicalTrials.gov Identifier:
NCT01746810
First received: November 26, 2012
Last updated: April 2, 2014
Last verified: April 2014
  Purpose

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.


Condition Intervention
Recurrent Non-small Cell Lung Cancer
Radiation: Stereotactic body RT and IRGA

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

Resource links provided by NLM:


Further study details as provided by New Mexico Cancer Care Alliance:

Primary Outcome Measures:
  • Maximum Tolerated Dose (MTD) [ Time Frame: 30 to 90 days ] [ Designated as safety issue: Yes ]
    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.


Secondary Outcome Measures:
  • Survival [ Time Frame: Up to 6 years ] [ Designated as safety issue: No ]
    Rates of local control, disease-free survival, and overall survival

  • Biomarker testing [ Time Frame: 2 weeks ] [ Designated as safety issue: No ]
    Size of tissue samples sufficient for DNA analyses

  • Pathological Response [ Time Frame: Up to 6 years ] [ Designated as safety issue: No ]
    Pathological response, changes in protein expression, and biomarker correlations with clinical outcome

  • Quality of Life [ Time Frame: Up to 6 years ] [ Designated as safety issue: No ]
    Quality of life (European Organization for the Research and Treatment of Cancer [EORTC])


Estimated Enrollment: 12
Study Start Date: July 2012
Estimated Study Completion Date: July 2019
Estimated Primary Completion Date: July 2018 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Stereotactic Body RT and IRGA
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.
Radiation: Stereotactic body RT and IRGA
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
Other Names:
  • Radiofrequency ablation
  • Microwave ablation

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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01746810

Locations
United States, New Mexico
University of New Mexico Cancer Center Recruiting
Albuquerque, New Mexico, United States, 87131
Contact: Valerie Parks, RN    505-925-0390    vparks@salud.unm.edu   
Principal Investigator: Thomas Schroeder, MD         
Sponsors and Collaborators
New Mexico Cancer Care Alliance
Investigators
Principal Investigator: Thomas Schroeder, MD UNM Cancer Center
  More Information

Additional Information:
No publications provided

Responsible Party: New Mexico Cancer Care Alliance
ClinicalTrials.gov Identifier: NCT01746810     History of Changes
Other Study ID Numbers: INST 1206
Study First Received: November 26, 2012
Last Updated: April 2, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by New Mexico Cancer Care Alliance:
Metastatic
Lung Cancer
NSCLC

Additional relevant MeSH terms:
Carcinoma, Non-Small-Cell Lung
Lung Neoplasms
Bronchial Neoplasms
Carcinoma, Bronchogenic
Lung Diseases
Neoplasms
Neoplasms by Site
Respiratory Tract Diseases
Respiratory Tract Neoplasms
Thoracic Neoplasms

ClinicalTrials.gov processed this record on October 22, 2014