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

Study Overview
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Brief Summary
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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.

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

Conditions
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Non-Small Cell Lung Cancer

Intervention / Treatment
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* Radiation: PET positive nodal disease measuring 15 mm or greater
* Radiation: PET positive nodal disease measuring less than 15 mm
* Radiation: Patients considered resectable


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: PET positive nodal disease measuring 15 mm or greater<br>Proton radiation with concomitant chemotherapy | Radiation: PET positive nodal disease measuring 15 mm or greater<br>* Proton radiation at 2 cobalt gray equivalent per fraction to a total of 74 cobalt gray equivalent with concomitant weekly chemotherapy.<br>* Other names: Proton Radiation;|
| Experimental: PET positive nodal disease measuring less than 15 mm<br>Proton radiation | Radiation: PET positive nodal disease measuring less than 15 mm<br>* Proton radiation at 2 cobalt gray equivalent per fraction to a total of 60 cobalt gray equivalent with concomitant weekly chemotherapy.<br>* Other names: Proton Radiation;|
| Experimental: Patients considered resectable<br>Proton radiation plus surgery | Radiation: Patients considered resectable<br>* Proton radiation at 2 cobalt gray per fraction. Re-evaluation performed between days 18-22 of treatment. If considered resectable after re-evaluation, radiotherapy will discontinue after a total of 50 cobalt gray equivalent and surgery will be performed.<br>* Other names: Proton Radiation;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Grade 3 or Higher Rate of Non-hematologic, Acute Treatment-related Toxicities |  | Six months after end of radiation therapy | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of Patients With Disease Control | 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. | Following treatment every 6 months for 2 years, then annually for 4 years. | 
| Percentage of Patients Alive at 5 Years |  | Five years following radiation treatment | 
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Non-small cell lung Cancer, Proton Radiation, Stage III