Clinical trial NCT00881712: Proton Therapy With Chemotherapy for Stage III Non-Small Cell Lung Cancer (LU02)
Official title: A Phase II Trial of 3 Dimensional Proton Radiotherapy With Concomitant Chemotherapy for Patients With Initially Unresectable Stage III Non-Small Cell Lung Cancer
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Non-Small Cell Lung Cancer
Keywords: Non-small cell lung Cancer
Proton Radiation
Stage III
Lead sponsor: University of Florida
Sponsor class: OTHER
First posted: 2009-04-15
Enrollment: 15
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Grade 3 or Higher Rate of Non-hematologic, Acute Treatment-related Toxicities
timeFrame: Six months after end of radiation therapy
Secondary outcomes:
measure: Percentage of Patients With Disease Control
timeFrame: Following treatment every 6 months for 2 years, then annually for 4 years.
measure: Percentage of Patients Alive at 5 Years
timeFrame: Five years following radiation treatment
measure: Feasibility, Safety and Efficacy of Delivering Proton Radiotherapy With Concomitant Chemotherapy
timeFrame: Weekly during treatment, then every 3 months for 1 year, every 4 months for 2 years, every 6 months for 2 years, then annually
measure: Correlation of Functional CT-PET Imaging With Treatment Outcomes
timeFrame: 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
Other outcomes:
Locations:
city: Jacksonville
country: United States
facility: University of Florida Proton Therapy Institute
state: Florida
Study officials:
affiliation: University of Florida Proton Therapy Institute
name: Bradford S Hoppe, MD, MPH
role: PRINCIPAL_INVESTIGATOR
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