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

Not Applicable

Terminated

Interventions: Radiation: PET positive nodal disease measuring less than 15 mm
Radiation: PET positive nodal disease measuring 15 mm or greater
Radiation: Patients considered resectable

Brief Summary: 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.

Recruitment & Eligibility

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.

Arm && Interventions

Group	Intervention	Description
PET positive nodal disease measuring less than 15 mm	PET positive nodal disease measuring less than 15 mm	Proton radiation
PET positive nodal disease measuring 15 mm or greater	PET positive nodal disease measuring 15 mm or greater	Proton radiation with concomitant chemotherapy
Patients considered resectable	Patients considered resectable	Proton radiation plus surgery

Primary Outcome Measures

Name	Time	Method
Grade 3 or Higher Rate of Non-hematologic, Acute Treatment-related Toxicities	Six months after end of radiation therapy

Secondary Outcome Measures

Name	Time	Method
Percentage of Patients With Disease Control	Following treatment every 6 months for 2 years, then annually for 4 years.	Disease control rate is defined as Complete Response (CR) + Partial Response (PR) + Stable Disease (SD). As per RECIST version 1.1, Complete Response (CR): Disappearance of all target lesions, Partial Response (PR): At least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters, Stable Disease (SD): Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum diameters while on study."), as accurate.
Feasibility, Safety and Efficacy of Delivering Proton Radiotherapy With Concomitant Chemotherapy	Weekly during treatment, then every 3 months for 1 year, every 4 months for 2 years, every 6 months for 2 years, then annually
Correlation of Functional CT-PET Imaging With Treatment Outcomes	Prestudy, before surgery (if applicable) between days 18-22 if needed, then during follow-up every 6 months for 2 years, then annually for 4 years
Percentage of Patients Alive at 5 Years	Five years following radiation treatment