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Sponsored by: |
University of Chicago |
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Information provided by: | University of Chicago |
ClinicalTrials.gov Identifier: | NCT00887315 |
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 |
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Non-Small Cell Lung Cancer |
Drug: Docetaxel and cisplatin Radiation: Docetaxel and cisplatin Plus Hypofractionated Radiotherapy |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Open Label, Parallel Assignment, Safety/Efficacy Study |
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 |
Estimated Enrollment: | 40 |
Study Start Date: | April 2009 |
Estimated Primary Completion Date: | June 2011 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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Group 1: Active Comparator
Chemotherapy only
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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
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2: Active Comparator
Chemotherapy and hypofractionated image guided radiotherapy
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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
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Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Patients with AJCC stage IV cancer with distant metastases and without malignant pleural or pericardial effusion at diagnosis and before start of study
Exclusion Criteria:
Contact: Everett E. Vokes, M.D. | 773-702-9306 | evokes@medicine.bsd.uchicago.edu |
Contact: Joseph Salama, M.D. | (773) 702-6870 | jsalama@radonc.uchicago.edu |
United States, Illinois | |
The University of Chicago | Recruiting |
Chicago, Illinois, United States, 60637 | |
Contact: Livia Szeto 773-834-0783 lszeto@medicine.bsd.uchicago.edu | |
Principal Investigator: Everett E. Vokes, MD | |
Sub-Investigator: Joseph K. Salama, MD |
Responsible Party: | Section of Hematology/ Oncology, The University of chicago ( Everett E. Vokes, M.D. ) |
Study ID Numbers: | SMART NSCLC |
Study First Received: | April 22, 2009 |
Last Updated: | April 22, 2009 |
ClinicalTrials.gov Identifier: | NCT00887315 History of Changes |
Health Authority: | United States: Institutional Review Board |
NSCLC Metastatic Stage IV NSCLC Limited Volume Stage IV Non-small Cell Lung Cancer |
Docetaxel Thoracic Neoplasms Radiation-Sensitizing Agents Cisplatin Respiratory Tract Diseases Lung Neoplasms |
Lung Diseases Neoplasm Metastasis Non-small Cell Lung Cancer Carcinoma, Non-Small-Cell Lung Neoplasms, Glandular and Epithelial Carcinoma |
Thoracic Neoplasms Respiratory Tract Neoplasms Neoplasms by Histologic Type Antineoplastic Agents Physiological Effects of Drugs Pharmacologic Actions Carcinoma Docetaxel Neoplasms |
Neoplasms by Site Radiation-Sensitizing Agents Respiratory Tract Diseases Cisplatin Lung Neoplasms Therapeutic Uses Lung Diseases Carcinoma, Non-Small-Cell Lung Neoplasms, Glandular and Epithelial |