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The Synergistic Metastases Annihilation With Radiotherapy and Docetaxel (Taxotere) [SMART] Trial for Non-Small Cell Lung Cancer (NSCLC) (SMART)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00887315
Recruitment Status : Terminated (Slow accrual and loss of sponsor)
First Posted : April 23, 2009
Results First Posted : December 6, 2013
Last Update Posted : December 6, 2013
Information provided by (Responsible Party):
University of Chicago

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.

Condition or disease Intervention/treatment Phase
Non-small Cell Lung Cancer Drug: Docetaxel and cisplatin Radiation: Docetaxel and cisplatin Plus Hypofractionated Radiotherapy Phase 2

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 11 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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 Start Date : April 2009
Actual Primary Completion Date : March 2011
Actual Study Completion Date : June 2011

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Lung Cancer

Arm Intervention/treatment
Active Comparator: Group 1
Chemotherapy only
Drug: Docetaxel and cisplatin
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

Active Comparator: 2
Chemotherapy and hypofractionated image guided radiotherapy
Radiation: Docetaxel 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

Primary Outcome Measures :
  1. 1-Year Overall Survival [ Time Frame: 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 Outcome Measures :
  1. Overall PFS and CT Rate [ Time Frame: >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

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00887315

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United States, Illinois
The University of Chicago
Chicago, Illinois, United States, 60637
Sponsors and Collaborators
University of Chicago
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Principal Investigator: Everett E Vokes, MD University of Chicago

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Responsible Party: University of Chicago Identifier: NCT00887315     History of Changes
Other Study ID Numbers: 16574B
First Posted: April 23, 2009    Key Record Dates
Results First Posted: December 6, 2013
Last Update Posted: December 6, 2013
Last Verified: November 2013
Keywords provided by University of Chicago:
Metastatic Stage IV NSCLC
Limited Volume Stage IV Non-small Cell Lung Cancer
Additional relevant MeSH terms:
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Lung Neoplasms
Carcinoma, Non-Small-Cell Lung
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Lung Diseases
Respiratory Tract Diseases
Carcinoma, Bronchogenic
Bronchial Neoplasms
Antineoplastic Agents
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action