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

This study has been terminated.
(Slow accrual and loss of sponsor)
Sponsor:
Information provided by (Responsible Party):
Everett Vokes, University of Chicago
ClinicalTrials.gov Identifier:
NCT00887315
First received: April 22, 2009
Last updated: July 2, 2012
Last verified: July 2012
History of Changes
  Purpose

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 Intervention Phase
Non-small Cell Lung Cancer
 Drug: Docetaxel and cisplatin
Radiation: Docetaxel and cisplatin Plus Hypofractionated Radiotherapy
 Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: 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

Resource links provided by NLM:

MedlinePlus related topics: Cancer Lung Cancer
U.S. FDA Resources

Further study details as provided by University of Chicago:

Primary Outcome Measures:
  • 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. [ Time Frame: Survival will be assessed at 1 year from the date of study enrollment to date of death ] [ Designated as safety issue: No ]
  • 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. [ Time Frame: Survival will be assessed at 1 year from the date of study enrollment to date of death. ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Determine overall PFS;Assess 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 ] [ Designated as safety issue: Yes ]

Enrollment: 9
Study Start Date: April 2009
Study Completion Date: June 2011
Primary Completion Date: March 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00887315

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

No publications provided

Responsible Party: Everett Vokes, Chairman, Department of Medicine, University of Chicago
ClinicalTrials.gov Identifier: NCT00887315     History of Changes
Other Study ID Numbers: 16574B
Study First Received: April 22, 2009
Last Updated: July 2, 2012
Health Authority: United States: Institutional Review Board

Keywords provided by University of Chicago:
NSCLC
Metastatic Stage IV NSCLC
Limited Volume Stage IV Non-small Cell Lung Cancer

Additional relevant MeSH terms:
Carcinoma, Non-Small-Cell Lung
Lung Neoplasms
Neoplasm Metastasis
Carcinoma, Bronchogenic
Bronchial Neoplasms
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Neoplasms
Lung Diseases
 Respiratory Tract Diseases
Neoplastic Processes
Pathologic Processes
Docetaxel
Cisplatin
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Radiation-Sensitizing Agents
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on May 23, 2013