A Randomized Phase II Trial of Docetaxel, Cisplatin, and Hypofractionated Radiotherapy Versus Docetaxel and Cisplatin for Limited Volume Stage IV Non-small Cell Lung Cancer: The Synergistic Metastases Annihilation With Radiotherapy and Docetaxel (Taxotere) [SMART] Trial
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
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
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
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
6. Patients with exudative, bloody, or cytologically malignant effusions are not
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.