Non-small Cell Lung Cancer
Conditions
Keywords
NSCLC, Metastatic Stage IV NSCLC, Limited Volume Stage IV Non-small Cell Lung Cancer
Brief summary
Primary goal of the study is to assess the overall survival of the addition of hypofractionated image guided radiotherapy concurrently with Docetaxel and cisplatin. Survival will be assessed at 1 year from the date of study enrollment to date of death.
Interventions
Docetaxel 75 mg/m2 and cisplatin 75 mg/m2 IV repeated every 21 days for 2 additional cycles. For patients randomized to group 1, the chemotherapy is identical to that administered for the first 2 cycles
RADIATIONDocetaxel and cisplatin Plus Hypofractionated Radiotherapy
Docetaxel 75 mg/m2 and cisplatin 75 mg/m2 IV for 2 cycles along with hypofractionated radiotherapy to all known sites of disease
Sponsors
University of Chicago
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Age 18 years or older 2. Life expectancy \> 6 months 3. Histologically or cytologically confirmed diagnosis of NSCLC 4. Patients with AJCC stage IV cancer with distant metastases and without malignant pleural or pericardial effusion at diagnosis and before start of study 1. Patients with pleural effusion that is transudative, cytologically negative, and non-bloody are eligible as long as they are stable and do not impair the ability to define tumor volumes. 2. If a pleural effusion is too small for diagnostic thoracentesis, the patient will be eligible. 5. Primary and regional nodal disease that is encompassable in a reasonable radiotherapy portal: 6. Patients with 1-5 sites of disease and amenable to RT therapy as seen on standard imaging (CT, MRI, bone scan, PET scan) 7. Unidimensionally measurable disease (based on RECIST) is desirable but not strictly required. 8. Patients with brain metastases are allowed as long as they meet all other inclusion criteria. Brain metastases must be treated with whole brain radiotherapy and stereotactic radiosurgery or surgical resection followed by whole brain radiotherapy. 9. ECOG performance status \<2 10. No prior RT to currently involved tumor sites 11. Baseline peripheral neuropathy \< grade 1 12. Room air saturation (SaO2) \> 90% 13. Patients must have normal organ and marrow function 14. Men and women of childbearing potential must be willing to consent to using effective contraception while on treatment and for at least 3 months thereafter. 15. Signed Informed consent 16. Inclusion of Women and Minorities 17. RT: Patient must have a completed treatment plan approved by the protocol review team
Exclusion criteria
1. Uncontrolled intercurrent illness including, but not limited to, ongoing active infection, symptomatic congestive heart failure (CHF), unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with the study requirements 2. Patients with clinically significant pulmonary dysfunction, cardiomyopathy, or any history of clinically significant CHF are excluded. The exclusion of patients with active coronary heart disease will be at the discretion of the attending physician. 3. Patients with significant atelectasis such that CT definition of the gross tumor volume (GTV) is difficult to determine. 4. \< 1000 cc of tumor free lung. 5. Tumor volume and location which requires a lung volume-PTV \>40% to receive \>20 Gy (V20 \<40%). 6. Patients with exudative, bloody, or cytologically malignant effusions are not eligible. 7. Pregnancy or breast feeding (Women of child-bearing potential are eligible, but must consent to using effective contraception during therapy and for at least 3 months after completing therapy) 8. Patients must have no uncontrolled active infection other than that not curable without treatment of their cancer. 9. Patients with a history of severe hypersensitivity reaction to docetaxel or other drugs formulated with polysorbate 80. 10. Patient may not be receiving any other investigational agents.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 1-Year Overall Survival | Baseline to death from any cause, 1 year | Overall survival is assessed at 1 year from the date of study enrollment to date of death. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Overall PFS and CT Rate | >90 days | Overall PFS and CT rate is assessed response with PET and CT. Toxicity of addition of high dose focused RT to systemic therapy.Late (\>90 day) radiotherapy toxicity will be assessed with RTOG/EORTC late RT toxicity guidelines |
Countries
United States
Participant flow
Recruitment details
Funding was withdrawn before conclusions were reached so the study was terminated.
Participants by arm
| Arm | Count |
|---|---|
| Chemo Only Chemotherapy only | 7 |
| Chemo and Radiation Chemotherapy and radiotherapy | 4 |
| Total | 11 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Study termination | 7 | 4 |
Baseline characteristics
| Characteristic | Chemo Only | Chemo and Radiation | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 4 Participants | 4 Participants | 8 Participants |
| Age, Categorical Between 18 and 65 years | 3 Participants | 0 Participants | 3 Participants |
| Age Continuous | 66.4 years STANDARD_DEVIATION 10.6 | 74 years STANDARD_DEVIATION 3.2 | 69.1 years STANDARD_DEVIATION 9.2 |
| Sex: Female, Male Female | 5 Participants | 2 Participants | 7 Participants |
| Sex: Female, Male Male | 2 Participants | 2 Participants | 4 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
1-Year Overall Survival
Overall survival is assessed at 1 year from the date of study enrollment to date of death.
Time frame: Baseline to death from any cause, 1 year
Population: The study was terminated before conclusions were reached so no data was analyzed.
Secondary
Overall PFS and CT Rate
Overall PFS and CT rate is assessed response with PET and CT. Toxicity of addition of high dose focused RT to systemic therapy.Late (\>90 day) radiotherapy toxicity will be assessed with RTOG/EORTC late RT toxicity guidelines
Time frame: >90 days
Population: The study was terminated before conclusions were reached so no data was analyzed.