Lung Cancer
Conditions
Keywords
Lung Cancer
Brief summary
The purpose of this study is to evaluate the efficacy and toxicity stereotactic body radiation (SBRT) as consolidation following standard chemoradiation for patients with stage III non-small cell lung cancer.
Detailed description
This protocol will investigate the potential role of SBRT for patients with stage 3 NSCLC. Eligible patients will first have received standard 50.4 Gy chemoradiation. Patients entering the study will have the opportunity to receive SBRT as a noninvasive option as compared to surgical resection. For patients who are not surgical candidates, SBRT after 50.4 Gy chemoradiation represents a technique of radiation consolidation that may be more effective and less toxic than standard conventional fractionated radiation
Interventions
RADIATIONStereotactic radiation Arm 1
Dose Levels Dose per Fraction Total Dose 1 8 Gy 16 Gy
RADIATIONStereotactic radiation Arm 2
Dose Levels Dose per Fraction Total Dose 2 10 Gy 20 Gy
RADIATIONStereotactic radiation Arm 3
Dose Levels Dose per Fraction Total Dose 3 12 Gy 24 Gy
RADIATIONStereotactic radiation Arm 4
Dose Levels Dose per Fraction Total Dose 4 14 Gy 28 Gy
Sponsors
Memorial Hospital of Rhode Island
Dr Thomas DiPetrillo
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
PATIENT ELIGIBILITY Conditions for Patient Eligibility (Inclusion) * Pathologically or cytologically confirmed NSCLC * Stage III NSCLC according to the AJCC 7th edition staging criteria. Stage II (T1-3N1) patient that are deemed medically inoperable are also eligible. * Concurrent chemoradiation to a radiation dose of 50.4 Gy. * residual tumor volume after concurrent chemoradiation that is appropriate for SBRT: * Primary tumor \<120cc (approximately 6cm diameter). * Mediastinal/Hilar disease: 1-2 involved regions \<60cc (approximately 5cmx3cmx3cm) * Absolute neutrophil count ≥ 1,000/uL, platelet ≥ 60,000/uL. * Total bilirubin ≤ 2x upper institutional limit of normal (ULN), and AST or ALT ≤5x ULN. * ECOG performance status 0 to 2 * Minimum life expectancy of 12 weeks. * Age older than 18 years. * Voluntary, signed written informed consent. * Women of childbearing potential must have a negative pregnancy test * Men and women of childbearing potential must be willing to consent to using effective contraception while on treatment and for at least 1 months thereafter. Conditions for Patient Ineligibility (Exclusion) * Disease progression during or after standard chemoradiation to 50.4 Gy * Prior thoracic radiation other than the pre-operative radiation not greater than 50.4 * Metastatic disease * Uncontrolled severe, intercurrent illness. * Women who are breast-feeding. * No chemotherapy within 2 weeks from the first SBRT treatment. * Concurrent anticancer therapy. * Prior complete resection of all NSCLC.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Early and Intermediate Toxicity for Dose Limiting Toxicity | 3 months | Any toxicity related to the radiation treatment will be scored and graded using National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) v4.0. Serious adverse events will be captured from the time the patient signs consent until 12 weeks after the last SBRT. DLTS: defined in protocol as: Dose limiting toxicities will be defined as grade 3 or greater treatment related pneumonitis, cardiac toxicity, bronchial injury or chest wall pain during or within 4 weeks of completion of SBRT. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Stereotactic Radiation stereotactic | 12 |
| Total | 12 |
Baseline characteristics
| Characteristic | Stereotactic Radiation |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 7 Participants |
| Age, Categorical Between 18 and 65 years | 5 Participants |
| Age, Continuous | 63.9 years |
| Region of Enrollment United States | 12 participants |
| Sex: Female, Male Female | 4 Participants |
| Sex: Female, Male Male | 8 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk |
|---|---|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — | — / — | — / — |
| other Total, other adverse events | 3 / 3 | 2 / 3 | 3 / 3 | 3 / 3 |
| serious Total, serious adverse events | 1 / 3 | 0 / 3 | 1 / 3 | 2 / 3 |
Outcome results
Primary
Early and Intermediate Toxicity for Dose Limiting Toxicity
Any toxicity related to the radiation treatment will be scored and graded using National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) v4.0. Serious adverse events will be captured from the time the patient signs consent until 12 weeks after the last SBRT. DLTS: defined in protocol as: Dose limiting toxicities will be defined as grade 3 or greater treatment related pneumonitis, cardiac toxicity, bronchial injury or chest wall pain during or within 4 weeks of completion of SBRT.
Time frame: 3 months
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Arm 1-Stereotactic Radiation Dose Level 1 | Early and Intermediate Toxicity for Dose Limiting Toxicity | 0 participants |
| Arm 2-Stereotactic Radiation Dose Level 2 | Early and Intermediate Toxicity for Dose Limiting Toxicity | 0 participants |
| Arm 3-Stereotactic Radiation Dose Level 3 | Early and Intermediate Toxicity for Dose Limiting Toxicity | 0 participants |
| Arm 4-Stereotactic Radiation Dose Level 4 | Early and Intermediate Toxicity for Dose Limiting Toxicity | 0 participants |