The Synergistic Metastases Annihilation With Radiotherapy and Docetaxel (Taxotere) [SMART] Trial for Non-Small Cell Lung Cancer (NSCLC)
Condition: Non-small Cell Lung Cancer
MeSH terms: Lung Neoplasms; Carcinoma, Non-Small-Cell Lung
Intervention: Docetaxel and cisplatin; Docetaxel and cisplatin Plus Hypofractionated Radiotherapy
Intervention description: 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; Docetaxel 75 mg/m2 and cisplatin 75 mg/m2 IV for 2 cycles along with hypofractionated radiotherapy to all known sites of disease
Intervention MeSH terms: Cisplatin; Docetaxel
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 11.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: NSCLC; Metastatic Stage IV NSCLC; Limited Volume Stage IV Non-small Cell Lung Cancer

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.
    

Eligibility criteria:

        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.