Trials / Completed

CompletedNCT02073968

PET-Adjusted Intensity Modulated Radiation Therapy and Combination Chemotherapy in Treating Patients With Stage II-IV Non-small Cell Lung Cancer

PET-Adjusted IMRT for NSCLC Trial (PAINT)

Status: Completed
Phase: Phase 2
Study type: Interventional
Enrollment: 35 (actual)

Sponsor: Albert Einstein College of Medicine · Academic / Other
Sex: All
Age: 18 Years
Healthy volunteers: Not accepted

Summary

This phase II trial studies how well intensity modulated radiation therapy adjusted by positron emission tomography (PET) scanning together with combination chemotherapy works in treating patients with stage II-IV non-small cell lung cancer (NSCLC). Radiation therapy uses high energy x rays to kill tumor cells. In intensity-modulated radiotherapy, multiple beam angles and dozens of beam segments are used to deliver highly conformal radiation therapy. Drugs used in chemotherapy, such as carboplatin and paclitaxel, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving PET-adjusted IMRT together with combination chemotherapy may kill more tumor cells.

Detailed description

PRIMARY OBJECTIVES: I. To estimate the efficacy (based on post-treatment PET findings) of dose-painted intensity-modulated radiotherapy (IMRT) with concurrent chemotherapy for locally-advanced non-small cell lung cancer (LA-NSCLC). SECONDARY OBJECTIVES: I. To estimate the efficacy (based on clinical endpoints including locoregional control \[LRC\], disease-free survival \[DFS\], and overall survival \[OS\]) of dose-painted IMRT with concurrent chemotherapy for LA-NSCLC. II. To evaluate the safety of dose-painted IMRT with concurrent and adjuvant chemotherapy for LA-NSCLC. III. To evaluate the utility of post-treatment PET/computed tomography (CT) imaging as a predictor of clinical outcomes following treatment with this novel approach. IV. To explore, in a preliminary manner, whether metabolomic markers in the blood and urine prior to and during the course of treatment are associated with treatment response, clinical endpoints, and treatment-related adverse events such as radiation pneumonitis. OUTLINE: RADIATION THERAPY: Patients undergo PET-adjusted IMRT or proton beam radiation therapy five days a week for 5 weeks. CONCURRENT CHEMOTHERAPY: Patients receive carboplatin intravenously (IV) over 3 hours and paclitaxel IV over 1 hour once weekly for 5 weeks beginning week 1 of thoracic radiotherapy. CONSOLIDATION CHEMOTHERAPY: Beginning approximately 4-6 weeks after the completion of all radiation therapy and when esophagitis and chemotherapy-induced neuropathy are grade 1 or less, absolute neutrophil count (ANC) \> 1500, and platelet count \> 100,000, patients may receive carboplatin IV over 30 minutes and paclitaxel IV over 3 hours on day 1. Treatment may repeat every 21 days for up to 3 courses in the absence of disease progression or unacceptable toxicity at the discretion of the treating physicians. After completion of study treatment, patients are followed up at 12-16 weeks, 19 weeks, every 3 months for 2 years, and then every 6 months for a total of 5 years.

Conditions

Interventions

Type	Name	Description
DRUG	Carboplatin	Given IV
PROCEDURE	Computed Tomography	Undergo PET-adjusted IMRT
RADIATION	Intensity-Modulated Radiation Therapy	Undergo PET-adjusted IMRT
DRUG	Paclitaxel	Given IV
PROCEDURE	Positron Emission Tomography	Undergo PET-adjusted IMRT
RADIATION	Proton Beam Radiation Therapy	Undergo proton beam radiation therapy

Timeline

Start date: 2013-07-01
Primary completion: 2017-12-01
Completion: 2020-11-01
First posted: 2014-02-28
Last updated: 2024-01-25
Results posted: 2020-01-22

Locations

2 sites across 1 country: United States

Regulatory

FDA-regulated device study

Source: ClinicalTrials.gov record NCT02073968. Inclusion in this directory is not an endorsement.