NCT01746810

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

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

• Status: Terminated
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 1 (actual)
• Sponsor: New Mexico Cancer Research Alliance · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Recurrent Non-small Cell Lung Cancer

Interventions

Type	Name	Description
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

Timeline

• Start date: 2012-07-01
• Primary completion: 2015-10-01
• Completion: 2015-10-13
• First posted: 2012-12-11
• Last updated: 2017-11-17

Locations

1 site across 1 country: United States