Proton Therapy With Chemotherapy for Stage III Non-Small Cell Lung Cancer (LU02)

A Phase II Trial of 3 Dimensional Proton Radiotherapy With Concomitant Chemotherapy for Patients With Initially Unresectable Stage III Non-Small Cell Lung Cancer

The purpose of this study is to find out what effects, good and/or bad, proton radiation at a higher tumor dose (and lower normal surrounding lung dose) combined with standard chemotherapy has on lung cancer. The dose you receive to the tumor will be higher than the standard dose. This may be able to increase the control of the tumor. Due to the accuracy of radiation given with protons, the dose to the normal lung tissue that surrounds the tumor will be lower than standard. This may be able to reduce the frequency and severity of the usual radiation side effects.

Inclusion Criteria:

• Histologically or cytologically documented non-small cell carcinoma of the lung diagnosed within 16 weeks prior to study enrollment.
• Patient must be at least 18 years old at the time of consent.
• Stage III A or III B disease.
• Patients must be able to start study treatment within 6 weeks of study enrollment.
• Induction chemotherapy is allowed.
• Marginally resectable or unresectable at presentation.
• If the patient had exploratory thoracotomy, it must be done at least 3 weeks prior to enrollment.

Exclusion Criteria:

• Evidence of distant metastasis.
• Prior thoracic radiotherapy.
• Any history of allergic reaction to taxanes.
• Prior tumor resection. Candidate for upfront curative surgery.
• Pleural effusion visible on chest x-ray or the scout view of the CT chest.
• Unintentional weight loss within the month prior to diagnosis ≥ 10%.
• Previous or concomitant malignancy other than early stage tumor treated more than 3 years ago for cure.
• The presence of PET positive contralateral hilar disease.