Combination Chemotherapy Plus Radiation Therapy Followed by Surgery in Treating Patients With Stage IIIB Non-Small Cell Lung Cancer
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|ClinicalTrials.gov Identifier: NCT00021112|
Recruitment Status : Terminated (low accrual)
First Posted : January 27, 2003
Last Update Posted : July 18, 2012
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 may kill more tumor cells.
PURPOSE: Phase II trial to study the effectiveness of combining chemotherapy and radiation therapy before surgery in treating patients who have stage IIIB non-small cell lung cancer.
|Condition or disease||Intervention/treatment||Phase|
|Lung Cancer||Drug: cisplatin Drug: etoposide Procedure: conventional surgery Radiation: radiation therapy||Phase 2|
- Determine the incidence of radically resected disease in patients with stage IIIB non-small cell lung cancer treated with induction cisplatin, etoposide, and radiotherapy followed by surgical resection.
- Determine the toxicity (morbidity and mortality) of this regimen in these patients.
- Determine the clinical response rate and pathological response rate in patients treated with this regimen.
OUTLINE: This is a multicenter study.
Patients receive induction chemotherapy comprising cisplatin IV on day 1 and etoposide IV on days 1-3. Chemotherapy repeats every 3 weeks for 3 courses. Beginning on day 2 of the second course of chemotherapy, patients undergo induction radiotherapy once daily 5 days a week for 5-7 weeks. Chemoradiotherapy continues in the absence of disease progression or unacceptable toxicity.
At 3-6 weeks after completion of the last dose of induction radiotherapy, patients undergo lobectomy or pneumonectomy.
Patients are followed at 30 days and 4 months, every 6 months for 2 years, and then annually thereafter.
PROJECTED ACCRUAL: A total of 27-62 patients will be accrued for this study.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||5 participants|
|Official Title:||Surgical Treatment Of Stage IIIB Non-Small Cell Lung Cancer After Induction-Chemoradiotherapy|
|Study Start Date :||April 2001|
|Primary Completion Date :||October 2002|
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00021112
|Algemeen Ziekenhuis Middelheim|
|Antwerp, Belgium, 2020|
|Universitair Ziekenhuis Antwerpen|
|Edegem, Belgium, B-2650|
|Heidelberg, Germany, D-69126|
|Gelre Ziekenhuizen - Lokatie Lukas|
|Apeldoorn, Netherlands, 7334 DZ|
|Sint Antonius Ziekenhuis|
|Nieuwegein, Netherlands, 3435 CM|
|Rotterdam Cancer Institute|
|Rotterdam, Netherlands, 3000 CA|
|University Hospital - Rotterdam Dijkzigt|
|Rotterdam, Netherlands, 3000 CA|
|Academisch Ziekenhuis Utrecht|
|Utrecht, Netherlands, 3584 CX|
|Medical University of Gdansk|
|Gdansk, Poland, 80-211|
|National Institute of Tuberculosis and Lung Diseases|
|Study Chair:||Rob Van Klaveren, MD, PhD||University Medical Center Rotterdam at Erasmus Medical Center|