Non-Small Cell Lung Cancer
Conditions
Keywords
Non-small cell lung Cancer, Proton Radiation, Stage III
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.
Interventions
RADIATIONPET positive nodal disease measuring 15 mm or greater
Proton radiation at 2 cobalt gray equivalent per fraction to a total of 74 cobalt gray equivalent with concomitant weekly chemotherapy.
RADIATIONPET positive nodal disease measuring less than 15 mm
Proton radiation at 2 cobalt gray equivalent per fraction to a total of 60 cobalt gray equivalent with concomitant weekly chemotherapy.
RADIATIONPatients considered resectable
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.
Sponsors
University of Florida
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Grade 3 or Higher Rate of Non-hematologic, Acute Treatment-related Toxicities | Six months after end of radiation therapy |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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. |
| 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 | — |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| PET Positive Nodal Disease Measuring 15 mm or Greater Proton radiation with concomitant chemotherapy
PET positive nodal disease measuring 15 mm or greater: Proton radiation at 2 cobalt gray equivalent per fraction to a total of 74 cobalt gray equivalent with concomitant weekly chemotherapy. | 13 |
| PET Positive Nodal Disease Measuring Less Than 15 mm Proton radiation
PET positive nodal disease measuring less than 15 mm: Proton radiation at 2 cobalt gray equivalent per fraction to a total of 60 cobalt gray equivalent with concomitant weekly chemotherapy. | 0 |
| Patients Considered Resectable Proton radiation plus surgery
Patients considered resectable: 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. | 0 |
| Total | 13 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 |
|---|---|---|---|---|
| Overall Study | Death | 1 | 0 | 0 |
| Overall Study | Withdrawal by Subject | 1 | 0 | 0 |
Baseline characteristics
| Characteristic | Total | PET Positive Nodal Disease Measuring 15 mm or Greater |
|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 6 Participants | 6 Participants |
| Age, Categorical Between 18 and 65 years | 7 Participants | 7 Participants |
| Age, Continuous | 62 Years | 62 Years |
| Region of Enrollment United States | 13 participants | 13 participants |
| Sex: Female, Male Female | 4 Participants | 4 Participants |
| Sex: Female, Male Male | 9 Participants | 9 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — | — / — |
| other Total, other adverse events | 13 / 13 | 0 / 0 | 0 / 0 |
| serious Total, serious adverse events | 2 / 13 | 0 / 0 | 0 / 0 |
Outcome results
Primary
Grade 3 or Higher Rate of Non-hematologic, Acute Treatment-related Toxicities
Time frame: Six months after end of radiation therapy
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| PET Positive Nodal Disease Measuring 15 mm or Greater | Grade 3 or Higher Rate of Non-hematologic, Acute Treatment-related Toxicities | 1 participants |
Secondary
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
Population: This data was not collected as study was terminated early.
Secondary
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
Population: This data was not collected as study was terminated early.
Secondary
Percentage of Patients Alive at 5 Years
Time frame: Five years following radiation treatment
Population: Thirteen enrolled patients that completed treatment.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| PET Positive Nodal Disease Measuring 15 mm or Greater | Percentage of Patients Alive at 5 Years | 69 percentage of patients |
Secondary
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.
Population: Thirteen enrolled patients that completed treatment
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| PET Positive Nodal Disease Measuring 15 mm or Greater | Percentage of Patients With Disease Control | 69 percentage of participants |