Non Small Cell Lung Cancer
Conditions
Keywords
Non Small Cell Lung Cancer, Surgically inoperable, Radiation Therapy
Brief summary
This study will help researchers learn about the best dose of radiation to be used when treating large early stage non-small cell lung cancer (NSCLC) with a treatment called stereotactic ablative radiotherapy (SABR). Current treatments with SABR for early stage NSCLC show positive response. But, for large early stage NSCLC it may be better to give different SABR doses than what is used in routine early stage NSCLC treatment. It is not understood which dose is best for treating large early stage NSCLC. Therefore, this study can help researchers learn if giving a higher dose using SABR over a period of 5-10 treatment days can increase the chance of cure for large early stage NSCLC.
Detailed description
Treatment Plan: 7.5 Gy x 10 daily fractions delivered with volumetric modulated arc therapy (VMAT) or regular intensity-modulated radiation therapy (IMRT). * Optional schedule of 12 Gy x 5 daily fractions can may also be used ONLY in situations where dose constraints for organs at risk can be EASILY met while optimal planning target volume (PTV) coverage is achieved; but the 7.5 Gy x 10 daily fractions schedule is preferred. * All doses are prescribed to the tumor periphery. For this protocol, patients will be followed only up to 2 years post radiation therapy.
Interventions
RADIATIONImage Guided Stereotactic Ablative Radiotherapy
Sponsors
American Cancer Society, Inc.
West Virginia University
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
* Non-Small Cell Lung Cancer * T2N0M0 or T3(PL3)N0M0 or Locally recurrent ≤ 7 cm * Surgically inoperable * ECOG Performance 0-2
Exclusion criteria
* Pacemaker on the same side of the tumor * Pregnant * Infection that requires IV antibiotics * Concomitant or adjuvant anti-neoplastic chemotherapy
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Local Control Rate (Absence of Local Progression) Using SABR for Treatment of NSCLC | 2 years |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Best Response | 2 years | To determine the 2-year regional, and distant metastasis rates, progression-free survival (PFS), local progression free survival (L-PFS), overall survival (OS) |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| A - 7.5 Gy x 10 Daily Fractions Radiotherapy: 7.5 Gy x 10 daily fractions delivered with VMAT or regular IMRT at West Virginia University.
Image Guided Stereotactic Ablative Radiotherapy | 3 |
| B - 12 Gy x 5 Daily Fractions Radiotherapy: Optional schedule of 12 Gy x 5 daily fractions can may also be used ONLY in situations where dose constraints for organs at risk can be EASILY met while optimal PTV coverage is achieved
Image Guided Stereotactic Ablative Radiotherapy | 0 |
| Total | 3 |
Baseline characteristics
| Characteristic | A - 7.5 Gy x 10 Daily Fractions | Total |
|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 3 Participants | 3 Participants |
| Ethnicity (NIH/OMB) Hispanic or Latino | 0 Participants | 0 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 3 Participants | 3 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants | 0 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 3 Participants | 3 Participants |
| Region of Enrollment United States | 3 participants | 3 participants |
| Sex: Female, Male Female | 2 Participants | 2 Participants |
| Sex: Female, Male Male | 1 Participants | 1 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 0 | 0 / 0 |
| serious Total, serious adverse events | 0 / 0 | 0 / 0 |
Outcome results
Primary
Local Control Rate (Absence of Local Progression) Using SABR for Treatment of NSCLC
Time frame: 2 years
Population: Data is not available because the study was terminated and the original PI left the institution. All efforts were made to contact the PI/study team, but we were unsuccessful. No outcome measures data was available.
Secondary
Best Response
To determine the 2-year regional, and distant metastasis rates, progression-free survival (PFS), local progression free survival (L-PFS), overall survival (OS)
Time frame: 2 years
Population: Data is not available because the study was terminated and the original PI left the institution. All efforts were made to contact the PI/study team, but we were unsuccessful. No outcome measures data was available.