Radiation Therapy with Chemotherapy, Inoperable Lung Cancer

Clinical Trial: Lung Cancer

Study Evaluating Treatment Course Of A Short, Intense Radiation Therapy Along With Standard Chemotherapy For Medically Inoperable Lung Cancer

Technical Title: Image-Guided Hypofractionated Radiotherapy with Stereotactic Boost and Chemotherapy for Inoperable Stage II-III Non-Small Cell Lung Cancer

Basic Information

Advanced non-small cell lung cancer has a poor outcome with standard of care chemotherapy and radiation therapy (7 weeks). This is a study to test the safety and efficacy of a new schedule of radiation therapy and chemotherapy. Our goal is to improve patient outcomes through a new clinical trial using a more aggressive, compact (3 weeks) schedule of chemotherapy and radiation therapy where we give more daily radiation than standard of care, thoughtfully. We are able to do this at UCLA given our vast clinical experience in hypofractionated (shorter course) radiotherapy, our advanced treatment machines, our superb treatment team, and our expertise in using daily state-of-the-art real-time imaging to customize and individualize the radiation therapy for each patient. Our goal is to improve your outcome while living with advanced non-small cell lung cancer. However, this new schedule of radiation and chemotherapy is experimental with no guarantee that it will benefit individual subjects. To learn about clinical trials using this type of treatment, contact:

• Care Felix, Study Coordinator – (310) 825-6577
• Percy Lee, M.D., Principal Investigator

Procedures

Research Procedure:

The investigator will design a treatment plan following a PET/CT planning scan consisting of 15 radiation treatment sessions, each taking less than one hour. Standard chemotherapy treatment may be administered, during, and 14 days after treatment.

Follow-up Visits:

A three month post radiotherapy and an annual PET-CT scan will be required to monitor your progress. CT scans will be every three months when there is no scheduled PET-CT. Blood tests will be required 4 – 6 weeks post radiotherapy, and then every three months for the first two years.

Eligibility Criteria

Inclusion Criteria

• Eligible patients will have medically inoperable, non-metastatic Stage II or III Lung Cancer (squamous cell carcinoma, adenocarcinoma, squamousadeno carcinoma, large-cell carcinoma, and non-small cell carcinoma not otherwise specified).
• Age >18
• Must be able to care for self, but may be unable to carry on normal activity or to do active work.
• Negative serum pregnancy test must be documented
• Women of childbearing potential must agree to use adequate contraception (hormonal or barrier method of birth control; or abstinence) for duration of study treatment and for up to 4 weeks following the study treatment.
• The ability to understand and the willingness to sign a written informed consent are necessary.

Exclusion Criteria

• Patients with tumor parameters that fall outside of the inclusion criteria.
• Patients who have had prior radiation treatment to the chest.
• Active systemic, pulmonary, or pericardial infection.
• Use of concurrent chemotherapy other than a standard platinum-based medication during radiotherapy
• Pregnant women, or women of childbearing potential who are sexually active and not willing/able to use medically acceptable forms of contraception for the entire study period and for up to 4 weeks after the study treatment.
• Patients who are participating in a concurrent treatment protocol

For More Detailed Information Contact:

• Percy Lee, M.D., Principal Investigator (310) 825-9771
• Care Felix, Study Coordinator (310) 825-6577
• Clinical Research Team (310) 825-6577