Clinical trial NCT00887315: The Synergistic Metastases Annihilation With Radiotherapy and Docetaxel (Taxotere) [SMART] Trial for Non-Small Cell Lung Cancer (NSCLC)
Official title: 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
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE2
Conditions: Non-small Cell Lung Cancer
Keywords: NSCLC
Metastatic Stage IV NSCLC
Limited Volume Stage IV Non-small Cell Lung Cancer
Lead sponsor: University of Chicago
Sponsor class: OTHER
First posted: 2009-04-23
Enrollment: 11
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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.

Primary outcomes:
measure: 1-Year Overall Survival
timeFrame: Baseline to death from any cause, 1 year
Secondary outcomes:
measure: Overall PFS and CT Rate
timeFrame: >90 days
Other outcomes:
Locations:
city: Chicago
country: United States
facility: The University of Chicago
state: Illinois
Study officials:
affiliation: University of Chicago
name: Everett E Vokes, MD
role: PRINCIPAL_INVESTIGATOR
References: