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

Primary Purpose

Recurrent Non-small Cell Lung Cancer

Status

Terminated

Phase

Phase 1

Locations

United States

Study Type

Interventional

Intervention

Stereotactic body RT and IRGA

About this trial

This is an interventional treatment trial for Recurrent Non-small Cell Lung Cancer focused on measuring Metastatic, Lung Cancer, NSCLC

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

University of New Mexico Cancer Center

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Stereotactic Body RT and IRGA

Arm Description

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.

Outcomes

Primary Outcome Measures

Maximum Tolerated Dose (MTD)

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

Rates of local control, disease-free survival, and overall survival

Biomarker testing

Size of tissue samples sufficient for DNA analyses

Pathological Response

Pathological response, changes in protein expression, and biomarker correlations with clinical outcome

Quality of Life

Quality of life (European Organization for the Research and Treatment of Cancer [EORTC])

Full Information

NCT ID

NCT01746810

First Posted

November 26, 2012

Last Updated

November 15, 2017

Sponsor

New Mexico Cancer Care Alliance

1. Study Identification

Unique Protocol Identification Number

NCT01746810

Brief Title

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

2. Study Status

Record Verification Date

November 2017

Overall Recruitment Status

Terminated

Why Stopped

Closed study as requested by PI due to lack of accruals

Study Start Date

July 2012 (Actual)

Primary Completion Date

October 2015 (Actual)

Study Completion Date

October 13, 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

New Mexico Cancer Care Alliance

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Recurrent Non-small Cell Lung Cancer

Keywords

Metastatic, Lung Cancer, NSCLC

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 1

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

1 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Stereotactic Body RT and IRGA

Arm Type

Experimental

Arm Description

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.

Intervention Type

Radiation

Intervention Name(s)

Stereotactic body RT and IRGA

Other Intervention Name(s)

Radiofrequency ablation, Microwave ablation

Intervention Description

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 Outcome Measure Information:

Title

Maximum Tolerated Dose (MTD)

Description

Time Frame

30 to 90 days

Secondary Outcome Measure Information:

Title

Survival

Description

Rates of local control, disease-free survival, and overall survival

Time Frame

Up to 6 years

Title

Biomarker testing

Description

Size of tissue samples sufficient for DNA analyses

Time Frame

2 weeks

Title

Pathological Response

Description

Pathological response, changes in protein expression, and biomarker correlations with clinical outcome

Time Frame

Up to 6 years

Title

Quality of Life

Description

Quality of life (European Organization for the Research and Treatment of Cancer [EORTC])

Time Frame

Up to 6 years

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Thomas Schroeder, MD

Organizational Affiliation

UNM Cancer Center

Official's Role

Principal Investigator

Facility Information:

Facility Name

University of New Mexico Cancer Center

City

Albuquerque

State/Province

New Mexico

ZIP/Postal Code

87131

Country

United States

12. IPD Sharing Statement

Plan to Share IPD

Links:

URL

http://www.cancer.unm.edu

Description

UNM Cancer Center

URL

http://www.nmcca.org

Description

New Mexico Cancer Care Alliance

Learn more about this trial

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

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