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| Sponsored by: |
Swiss Group for Clinical Cancer Research |
| Information provided by: | National Cancer Institute (NCI) |
| ClinicalTrials.gov Identifier: | NCT00030810 |
Purpose
RATIONALE: Drugs used in chemotherapy 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 chemotherapy with radiation therapy before surgery may shrink the tumor so that it can be removed during surgery.
PURPOSE: Phase II trial to study the effectiveness of combination chemotherapy followed by radiation therapy before surgery in treating patients who have stage IIIB non-small cell lung cancer.
| Condition | Intervention | Phase |
|
Lung Cancer |
Drug: cisplatin Drug: docetaxel Procedure: conventional surgery Procedure: neoadjuvant therapy Procedure: radiation therapy |
Phase II |
| MedlinePlus related topics: | Cancer Lung Cancer |
| ChemIDplus related topics: | Cisplatin Docetaxel |
| Study Type: | Interventional |
| Study Design: | Treatment |
| Official Title: | Preoperative Chemoradiotherapy In Non-Small Cell Lung Cancer (NSCLC) Patients With Operable Stage IIIB Disease: A Prospective Phase II Trial |
| Estimated Enrollment: | 46 |
| Study Start Date: | September 2001 |
OBJECTIVES:
OUTLINE: This is a multicenter study.
Patients receive docetaxel IV over 1 hour and cisplatin IV over 1 hour on day 1. Treatment repeats every 3 weeks for 3 courses in the absence of unacceptable toxicity.
Beginning 3 weeks after the last chemotherapy dose, patients without progressive disease receive radiotherapy 1-2 times daily on days 1-5, 8-12, and 15-19.
Patients undergo surgery within 3-4 weeks after completion of radiotherapy.
Patients are followed at 1 month and then every 3 months thereafter.
PROJECTED ACCRUAL: A total of 15-46 patients will be accrued for this study.
Eligibility
| Ages Eligible for Study: | 18 Years to 75 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Histologically confirmed, operable stage IIIB non-small cell lung cancer
PATIENT CHARACTERISTICS:
Age:
Performance status:
Life expectancy:
Hematopoietic:
Hepatic:
Renal:
Cardiovascular:
Other:
PRIOR CONCURRENT THERAPY:
Biologic therapy:
Chemotherapy:
Endocrine therapy:
Radiotherapy:
Surgery:
Other:
Contacts and Locations| Switzerland | |||||
| Centre Hospitalier Universitaire Vaudois | |||||
| Lausanne, Switzerland, CH-1011 | |||||
| Swiss Group for Clinical Cancer Research |
| Study Chair: | Roger Stupp, MD | Centre Hospitalier Universitaire Vaudois |
More Information
Clinical trial summary from the National Cancer Institute's PDQ® database 
  |
| Pless M, Stupp R, Kann R, et al.: Preoperative chemoradiotherapy in non-small cell lung cancer (NSCLC) patients with operable stage IIIB disease: a phase II trial of the Swiss Group for Clinical Cancer Research (SAKK). [Abstract] J Clin Oncol 25 (Suppl 18): A-18021, 685s, 2007. |
| Study ID Numbers: | CDR0000069199, SWS-SAKK-16/01, EU-20137 |
| First Received: | February 14, 2002 |
| Last Updated: | July 23, 2008 |
| ClinicalTrials.gov Identifier: | NCT00030810 |
| Health Authority: | United States: Federal Government |
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