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

NCT01746810 | Terminated Phase 1 DMC

• 1 other identifier: INST 1206
• Study Type: interventional
• Target: 1
• Locations: 1 country
• Sites: 1

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.

Conditions

Recurrent Non-small Cell Lung Cancer

Keywords

Metastatic; Lung Cancer; NSCLC

Outcome Measures

Primary Outcomes (1)

• 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.

  30 to 90 days

Secondary Outcomes (4)

• Survival

  Up to 6 years

• Biomarker testing

  2 weeks

• Pathological Response

  Up to 6 years

• Quality of Life

  Up to 6 years

Study Arms (1)

Stereotactic Body RT and IRGA

EXPERIMENTAL

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

Interventions

Stereotactic body RT and IRGA RADIATION

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

Also known as: Radiofrequency ablation, Microwave ablation

Stereotactic Body RT and IRGA

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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

Sponsors & Collaborators

• New Mexico Cancer Research Alliance: lead

Study Sites (1)

University of New Mexico Cancer Center

Albuquerque, New Mexico, 87131, United States

Location

Related Links

• UNM Cancer Center
• New Mexico Cancer Care Alliance

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell Lung; Neoplasm Metastasis; Lung Neoplasms

Interventions

Radiofrequency Ablation

Condition Hierarchy (Ancestors)

Carcinoma, Bronchogenic; Bronchial Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases; Neoplastic Processes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Radiofrequency Therapy; Therapeutics; Ablation Techniques; Surgical Procedures, Operative

Study Officials

• Thomas Schroeder, MD

  UNM Cancer Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 26, 2012
• First Posted: December 11, 2012
• Study Start: July 1, 2012
• Primary Completion: October 1, 2015
• Study Completion: October 13, 2015
• Last Updated: November 17, 2017

Record last verified: 2017-11

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)