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

University of Florida15 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

NON_RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Non-Small Cell Lung Cancer

Interventions

PET positive nodal disease measuring 15 mm or greaterRADIATION

Proton radiation at 2 cobalt gray equivalent per fraction to a total of 74 cobalt gray equivalent with concomitant weekly chemotherapy.

PET positive nodal disease measuring less than 15 mmRADIATION

Proton radiation at 2 cobalt gray equivalent per fraction to a total of 60 cobalt gray equivalent with concomitant weekly chemotherapy.

Patients considered resectableRADIATION

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.

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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.

Locations (1)

University of Florida Proton Therapy Institute

Jacksonville, Florida, United States

Outcomes

Primary Outcomes

Grade 3 or Higher Rate of Non-hematologic, Acute Treatment-related Toxicities

Time frame: Six months after end of radiation therapy

Secondary Outcomes

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.

Time frame: Following treatment every 6 months for 2 years, then annually for 4 years.

Percentage of Patients Alive at 5 Years

Time frame: Five years following radiation treatment

Feasibility, Safety and Efficacy of Delivering Proton Radiotherapy With Concomitant Chemotherapy

Time frame: 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

Time frame: 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

Data from ClinicalTrials.gov

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