RecruitingEarly Phase 1NCT02619448

Concurrent Chemotherapy Plus HFR Radiation Therapy in Inoperable NSCLC

Pilot Study of the Safety and Feasibility of Administering Concurrent Chemotherapy and Accelerated Hypofractionated Radiation Therapy in the Treatment of Medically Inoperable T2A-T4 N0 Non-small Cell Lung Cancer.


Sponsor

State University of New York - Upstate Medical University

Enrollment

12 participants

Start Date

Dec 1, 2014

Study Type

INTERVENTIONAL

Conditions

Summary

The standard treatment for patients with Non-Small Cell Lung Cancer (NSCLC) and clinically negative lymph nodes remains surgery per current guidelines. Five year survival for patients with stage I non-small cell lung cancer is generally greater than 50% after surgery. Many of these patients have heart and lung issues or other diseases which keep them from undergoing curative surgery. Studies have shown that majority of these patients die from their cancer and not from their other diseases. This is the reason for treating early stage lung cancer patients with definitive therapy, when they cannot have surgery. This study will enroll twelve subjects to evaluate the side effects of this treatment, and decide if it is a good option for the patients that cannot have surgery.


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is testing a specific radiation therapy approach called hypofractionated radiation (fewer, larger doses given over a shorter time) combined with chemotherapy for patients with lung cancer that cannot be treated with surgery. **You may be eligible if...** - You have been diagnosed with non-small cell lung cancer (NSCLC), confirmed by a tissue or cell sample - Your tumor is a single lesion between 2–7 cm in size - Your cancer has not spread to lymph nodes or other parts of the body - You are considered a good candidate for this type of radiation therapy - Your lungs are functioning well enough to tolerate treatment - You are able to perform basic daily activities (measured by performance score) **You may NOT be eligible if...** - You have more than one tumor or the cancer has spread - Your lung function is too poor to safely receive radiation - You have already received radiation to the chest area - You have a serious heart condition or other illness that would make treatment unsafe - You are pregnant Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGCarboplatin

chemotherapy

DRUGPaclitaxel

chemotherapy

RADIATION70 Gy in 20 fractions over 4 weeks

accelerated hypofractionated RT


Locations(1)

SUNY Upstate Medical University

Syracuse, New York, United States

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NCT02619448


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