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Sponsors and Collaborators: |
Southwest Oncology Group National Cancer Institute (NCI) Eastern Cooperative Oncology Group American College of Surgeons North Central Cancer Treatment Group National Cancer Institute of Canada Cancer and Leukemia Group B |
Information provided by: | National Cancer Institute (NCI) |
ClinicalTrials.gov Identifier: | NCT00062439 |
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.
Condition | Intervention | Phase |
Lung Cancer |
Drug: cisplatin Drug: docetaxel Drug: etoposide Procedure: adjuvant therapy Procedure: conventional surgery Procedure: neoadjuvant therapy Procedure: radiation therapy |
Phase II |
MedlinePlus related topics: | Cancer Lung Cancer |
ChemIDplus related topics: | Etoposide Docetaxel Cisplatin Etoposide phosphate |
Study Type: | Interventional |
Study Design: | Treatment, Open Label |
Official Title: | 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) |
Estimated Enrollment: | 45 |
Study Start Date: | July 2003 |
Estimated Primary Completion Date: | March 2007 (Final data collection date for primary outcome measure) |
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.
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Histologically or cytologically confirmed non-small cell lung cancer
Any of the following stages due to involvement of the superior sulcus:
Must meet 1 of the following tumor involvement criteria:
No involvement of the following lymph node groups as determined by mediastinal exploration* (i.e., mediastinoscopy, mediastinotomy, thoracoscopy, or thoracotomy) within the past 42 days:
Supraclavicular (scalene) nodes
No pleural effusions except if 1 of the following criteria are met:
PATIENT CHARACTERISTICS:
Age
Performance status
Zubrod 0-2
Life expectancy
Hematopoietic
Hepatic
Renal
Cardiovascular
Pulmonary
Other
PRIOR CONCURRENT THERAPY:
Biologic therapy
Chemotherapy
Endocrine therapy
Radiotherapy
Surgery
Other
Show 154 Study Locations |
Southwest Oncology Group |
National Cancer Institute (NCI) |
Eastern Cooperative Oncology Group |
American College of Surgeons |
North Central Cancer Treatment Group |
National Cancer Institute of Canada |
Cancer and Leukemia Group B |
Study Chair: | Michael J. Kraut, MD | Providence Cancer Institute at Providence Hospital - Southfield Campus |
Study Chair: | Tien Hoang, MD | University of Wisconsin, Madison |
Study Chair: | Valerie W. Rusch, MD, FACS | Memorial Sloan-Kettering Cancer Center |
Study Chair: | James R. Jett, MD | Mayo Clinic |
Study Chair: | Scott A. Laurie, MD, FRCPC | Ottawa Hospital Regional Cancer Centre - General Campus |
Study Chair: | Alan P. Lyss, MD | Missouri Baptist Cancer Center |
Clinical trial summary from the National Cancer Institute's PDQ® database 
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Study ID Numbers: | CDR0000304777, SWOG-S0220, ECOG-S0220, ACOSOG-SWOG-S0220, NCCTG-SWOG-S0220, CAN-NCIC-SWOG-S0220, CALGB-30501 |
First Received: | June 5, 2003 |
Last Updated: | July 23, 2008 |
ClinicalTrials.gov Identifier: | NCT00062439 |
Health Authority: | United States: Federal Government |
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