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| Tracking Information | |||||||||||||||||||||||||
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| First Received Date ICMJE | June 5, 2003 | ||||||||||||||||||||||||
| Last Updated Date | April 14, 2009 | ||||||||||||||||||||||||
| Start Date ICMJE | July 2003 | ||||||||||||||||||||||||
| Estimated Primary Completion Date | March 2009 (final data collection date for primary outcome measure) | ||||||||||||||||||||||||
| Current Primary Outcome Measures ICMJE |
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| Original Primary Outcome Measures ICMJE |
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| Change History | Complete list of historical versions of study NCT00062439 on ClinicalTrials.gov Archive Site | ||||||||||||||||||||||||
| Current Secondary Outcome Measures ICMJE | |||||||||||||||||||||||||
| Original Secondary Outcome Measures ICMJE | |||||||||||||||||||||||||
| Descriptive Information | |||||||||||||||||||||||||
| Brief Title ICMJE | Chemoradiotherapy Followed By Surgery and Docetaxel in Treating Patients With Pancoast Tumors | ||||||||||||||||||||||||
| Official Title ICMJE | A Phase II Trial of Induction Chemoradiotherapy With Cisplatin/Etoposide Followed by Surgical Resection, Followed by Docetaxel, for Non-Small Cell Lung Cancer Involving the Superior Sulcus (Pancoast Tumors) | ||||||||||||||||||||||||
| Brief Summary | RATIONALE: Drugs used in chemotherapy, such as cisplatin, etoposide, and docetaxel, use different ways to stop tumor cells from dividing so they stop growing or die. Radiation therapy uses high-energy x-rays to damage tumor cells. Combining cisplatin and etoposide with radiation therapy may shrink the tumor so it can be removed by surgery. Giving docetaxel after surgery may kill any remaining tumor cells. PURPOSE: This phase II trial is studying how well giving chemoradiotherapy together with cisplatin and etoposide followed by surgery and docetaxel works in treating patients with newly diagnosed Pancoast tumors, a type of non-small cell lung cancer. |
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| Detailed Description | OBJECTIVES:
OUTLINE:
Within 2-4 weeks after completion of induction chemoradiotherapy, patients undergo disease evaluation. Patients with no evidence of local or overall disease progression undergo a thoracotomy within 3-7 weeks. Patients who do not qualify for surgery proceed to consolidation chemotherapy within 3-8 weeks after chemoradiotherapy is complete.
Patients are followed at 4-6 weeks, every 3 months for 2 years, and then every 6 months for 3 years. PROJECTED ACCRUAL: A total of 45 patients will be accrued for this study. |
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| Study Phase | Phase II | ||||||||||||||||||||||||
| Study Type ICMJE | Interventional | ||||||||||||||||||||||||
| Study Design ICMJE | Treatment, Open Label | ||||||||||||||||||||||||
| Condition ICMJE | Lung Cancer | ||||||||||||||||||||||||
| Intervention ICMJE |
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| Study Arms / Comparison Groups | |||||||||||||||||||||||||
| Publications * | |||||||||||||||||||||||||
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* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline. |
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| Recruitment Information | |||||||||||||||||||||||||
| Recruitment Status ICMJE | Active, not recruiting | ||||||||||||||||||||||||
| Estimated Enrollment ICMJE | 45 | ||||||||||||||||||||||||
| Completion Date | |||||||||||||||||||||||||
| Estimated Primary Completion Date | March 2009 (final data collection date for primary outcome measure) | ||||||||||||||||||||||||
| Eligibility Criteria ICMJE | DISEASE CHARACTERISTICS:
PATIENT CHARACTERISTICS: Age
Performance status
Life expectancy
Hematopoietic
Hepatic
Renal
Cardiovascular
Pulmonary
Other
PRIOR CONCURRENT THERAPY: Biologic therapy
Chemotherapy
Endocrine therapy
Radiotherapy
Surgery
Other
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| Gender | Both | ||||||||||||||||||||||||
| Ages | |||||||||||||||||||||||||
| Accepts Healthy Volunteers | No | ||||||||||||||||||||||||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||||||||||||||||||||||
| Location Countries ICMJE | United States | ||||||||||||||||||||||||
| Administrative Information | |||||||||||||||||||||||||
| NCT ID ICMJE | NCT00062439 | ||||||||||||||||||||||||
| Responsible Party | Laurence H. Baker, Southwest Oncology Group - Group Chair's Office | ||||||||||||||||||||||||
| Study ID Numbers ICMJE | CDR0000304777, SWOG-S0220, ECOG-S0220, ACOSOG-SWOG-S0220, NCCTG-SWOG-S0220, CAN-NCIC-SWOG-S0220, CALGB-30501 | ||||||||||||||||||||||||
| Study Sponsor ICMJE | Southwest Oncology Group | ||||||||||||||||||||||||
| Collaborators ICMJE |
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| Investigators ICMJE |
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| Information Provided By | National Cancer Institute (NCI) | ||||||||||||||||||||||||
| Verification Date | November 2008 | ||||||||||||||||||||||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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