NCT01345851

Image-Guided Hypofractionated Radiation Therapy With Stereotactic Body Radiation Therapy Boost and Combination Chemotherapy in Treating Patients With Stage II-III Non-Small Cell Lung Cancer That Cannot Be Removed By Surgery

Image-Guided Hypofractionated Radiotherapy With Stereotactic Boost and Chemotherapy for Inoperable Stage II-III Non-Small Cell Lung Cancer

• Status: Active Not Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 29 (actual)
• Sponsor: Jonsson Comprehensive Cancer Center · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This clinical trial studies image-guided hypofractionated radiation therapy (RT) when given together with hypofractionated RT boost and combination chemotherapy in treating patients with stage II-III non-small cell lung cancer (NSCLC) that cannot be removed by surgery. RT uses high energy x-rays to kill tumor cells. Hypofractionated RT may be able to send x-rays directly to the tumor and cause less damage to normal tissue. 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 RT together with combination chemotherapy may kill more tumor cells and allow doctors to save the part of the body where the cancer started

Detailed description

PRIMARY OBJECTIVES: I. To determine the maximum tolerated dose (MTD) using hypofractionated RT in patients with stage II-III NSCLC. SECONDARY OBJECTIVES: I. To determine the dose-limiting toxicity, if the MTD is reached. II. To determine the tumor local control (LC). III. To determine the lung cancer disease specific survival (DSS). IV. To determine the overall survival (OS). V. To assess the transforming growth factor-beta (TGF-B), interleukin (IL)-1, and IL-6 levels as predictive biomarkers for treatment induced tissue injury. OUTLINE: This is a dose-escalation study of image-guided hypofractionated RT. Patients undergo image-guided hypofractionated RT over 35 minutes 5 days a week for 2 weeks followed by 5 fractions of hypofractionated RT boost. Patients also receive standard carboplatin and paclitaxel for 3 weeks. After completion of study treatment, patients are followed up at 4-6 weeks, every 3 months for the first 2 years, and then periodically thereafter.

Conditions

• Adenocarcinoma of the Lung
• Adenosquamous Cell Lung Cancer
• Large Cell Lung Cancer
• Recurrent Non-small Cell Lung Cancer
• Squamous Cell Lung Cancer
• Stage IIA Non-small Cell Lung Cancer
• Stage IIB Non-small Cell Lung Cancer
• Stage IIIA Non-small Cell Lung Cancer
• Stage IIIB Non-small Cell Lung Cancer

Interventions

Type	Name	Description
RADIATION	hypofractionated radiation therapy	Undergo image-guided hypofractionated Radiation Therapy over 35 minutes 5 days a week for 2 weeks
OTHER	laboratory biomarker analysis	Correlative studies
RADIATION	image-guided radiation therapy	Undergo 5 fractions of image-guided hypofractionated Radiation Therapy boost.
DRUG	carboplatin	The maximal chemotherapy treatment dose for carboplatin during the 3 week radiation therapy is AUC 2.
DRUG	paclitaxel	The maximal chemotherapy treatment dose for paclitaxel during the 3 week radiation therapy is 45mg/m2.
RADIATION	stereotactic body radiation therapy	Undergo hypofractionated RT

Timeline

• Start date: 2011-03-23
• Primary completion: 2027-01-31
• Completion: 2028-01-31
• First posted: 2011-05-02
• Last updated: 2026-02-25

Locations

1 site across 1 country: United States