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Chemotherapy Plus Radiation Therapy With or Without Surgery in Treating Patients With Stage IIIA Non-small Cell Lung Cancer Clinical Trials References presented on Clinical Trials Search is not intended to be a substitute for proven healthcare advice, trips or professional assistance by using a real medical. We aren't mDs. Always confer with your physician about Chemotherapy Plus Radiation Therapy With or Without Surgery in Treating Patients With Stage IIIA Non-small Cell Lung Cancer conditions. Clinical Trials Search.org is a website devoted to listing clinical research studies in human subjects. Chemotherapy Plus Radiation Therapy With or Without Surgery in Treating Patients With Stage IIIA Non-small Cell Lung Cancer Clinical research trials and Chemotherapy Plus Radiation Therapy With or Without Surgery in Treating Patients With Stage IIIA Non-small Cell Lung Cancer medical trials take place in hundreds of localities across the U.S.. A clinical trial or clinical study is a research project with human volunteer subjects. Clinical drug trials and pharmaceutical clinical trials usually evaluate the effectualness of new does drugs. The purpose of the studies / projects is to solve specific human health questions. Clinical trials are a popular way for physicians, government agencies, and private sector companies to discover treatments for all sorts of conditions, such as Chemotherapy Plus Radiation Therapy With or Without Surgery in Treating Patients With Stage IIIA Non-small Cell Lung Cancer. Chemotherapy Plus Radiation Therapy With or Without Surgery in Treating Patients With Stage IIIA Non-small Cell Lung Cancer Clinical Trials and other clinical trials permit volunteers to access healthcare treatment choices before they are available to the general public. Some times the subjects recieve professional assistance for without cost, and every now and again they are compensated for their time. Sometimes there is a cost for a Chemotherapy Plus Radiation Therapy With or Without Surgery in Treating Patients With Stage IIIA Non-small Cell Lung Cancer clinical trial. Subjects often receive the most expert healthcare possible for their Chemotherapy Plus Radiation Therapy With or Without Surgery in Treating Patients With Stage IIIA Non-small Cell Lung Cancer condition. Risks are a reality, nevertheless, and could include additional or frequent dr. calls, healthcare dangers (perhaps life-jeopardising), and/or the treatment being ineffective. Trials are federally governed with stern guidelines to protect clinical trials subjects.
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Home > "C" Clinical Trials Conditions > Chemotherapy Plus Radiation Therapy With or Without Surgery in Treating Patients With Stage IIIA Non-small Cell Lung Cancer  Chemotherapy Plus Radiation Therapy With or Without Surgery in Treating Patients With Stage IIIA Non-small Cell Lung Cancer
Chemotherapy Plus Radiation Therapy With or Without Surgery in Treating Patients With Stage IIIA Non-small Cell Lung Cancer
For Condition: squamous cell lung cancer,adenocarcinoma of the lung,bronchoalveolar cell lung cancer,stage 3A non-small cell lung cancer,large cell lung cancer
Status: Completed
Sponsor(s): National Cancer Institute (NCI) , Southwest Oncology Group,Eastern Cooperative Oncology Group,Cancer and Leukemia Group B,North Central Cancer Treatment Group,National Cancer Institute of Canada,Radiation Therapy Oncology Group
Synopsis: RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining radiation therapy with chemotherapy may kill more tumor cells. It is not yet known if chemotherapy plus radiation therapy is more effective with or without surgery for lung cancer. PURPOSE: Randomized phase III trial to compare the effectiveness of cisplatin and etoposide plus radiation therapy with or without surgery in treating patients with stage IIIA non-small cell lung cancer.
Details: OBJECTIVES: I. Compare the progression-free survival, median (2-year) survival, and long-term (5-year) survival in patients with newly diagnosed, stage IIIA (N2) non-small cell lung cancer treated with radiotherapy concurrently with cisplatin and etoposide with or without surgical resection. II. Compare the patterns of local and distant failure in patients treated with these regimens. III. Determine the relationship of tobacco use, alcohol use, and diet with toxicity of these regimens and outcome in both men and women. PROTOCOL OUTLINE: This is a randomized, multicenter study. Patients are stratified by contralateral mediastinal sampling or biopsy (yes vs no), tumor stage (T1 vs T2 vs T3), and performance status (70-80% vs 90-100%). Patients are randomized to 1 of 2 treatment arms. Arm I: Patients receive induction with cisplatin IV over 1 hour on days 1 and 8 and etoposide IV over 1 hour on days 1-5. Treatment continues every 4 weeks for 2 courses in the absence of disease progression or unacceptable toxicity. Beginning within 24 hours of the first dose of chemotherapy, patients undergo induction radiotherapy 5 days a week for 5 weeks in the absence of disease progression or unacceptable toxicity. Patients without local progression or distant metastases at 2-4 weeks after completion of course 2 undergo resection approximately 3-5 weeks after completion of course 2. All visible, accessible bronchopulmonary, hilar, and mediastinal lymph nodes are excised. The choice of surgical procedure (thoracotomy, lobectomy, or pneumonectomy with en bloc resection of tumor extending into the parietal pleura, chest wall, pericardium, or diaphragm) is at the discretion of the surgeon. Patients who undergo resection receive 2 additional courses of chemotherapy alone beginning 4-6 weeks postoperatively. Patients with unresectable disease or who are medically unfit for or refuse resection receive 2 additional courses of chemotherapy alone beginning immediately after completion of course 2. Arm II: Patients undergo induction chemoradiotherapy as in arm I but do not undergo resection. Patients without local progression or distant metastases within 1 week before anticipated completion of induction radiotherapy receive 2 additional courses of chemotherapy beginning immediately after completion of course 2. Patients without local or distant progression after completion of course 4 undergo boost radiotherapy for 8 days. Patients are followed every 2 months for 1 year, every 3 months for 2 years, and then every 6 months thereafter. PROJECTED ACCRUAL: A total of 510 patients will be accrued for this study within 4.9 years.
Eligibility:
Study Type: Interventional, Treatment
Minimum Age/Maximum Age: 18 Years/
Genders:
Protocol Entry Criteria: PROTOCOL ENTRY CRITERIA: --Disease Characteristics-- Histologically or cytologically proven newly diagnosed, stage IIIA (T1-3, N2) non-small cell lung cancer Eligible subtypes: - Adenocarcinoma - Large cell carcinoma - Squamous cell carcinoma - Nonlobar and nondiffuse bronchoalveolar cell carcinoma Measurable or evaluable disease on chest x-ray and/or contrast CT scan - Contrast thoracic CT required to complete staging Single primary bronchogenic tumor (no more than 1 parenchymal lung lesion) Pleural effusions allowed if 1 of the following conditions is met: - Negative cytology on thoracentesis if effusions present before mediastinoscopy or exploratory thoracotomy - Effusion seen on CT scan but not on chest x-ray and deemed too small to tap under CT or ultrasound guidance Positive ipsilateral mediastinal node(s) with or without positive ipsilateral hilar nodes - Mediastinal nodes separate from primary lesion on CT scan or surgical exploration - Histologic or cytologic proof of N2 disease by thoracotomy, mediastinoscopy, mediastinotomy, Chamberlain procedure, Wang needle, or fine needle aspiration under bronchoscopic or CT guidance - Nodal biopsy or aspiration waived if all of the following conditions are met: * Paralyzed left true vocal cord documented by bronchoscopy or indirect laryngoscopy * Nodes visible in Level 5 region on CT scan * Distinct primary lesion separate from nodes on CT scan - All mediastinal nodal involvement mapped (positive or negative) No positive nodes in contralateral mediastinum (supraclavicular areas and higher) and neck - Mediastinoscopy, mediastinotomy, Chamberlain procedure, or thoracotomy required for nodes larger than 1 cm on contrast CT scan - Surgery waived if nodes negative or no larger than 1 cm on CT scan - Lymphadenopathy allowed if biopsy proof of a benign cause - No metastases by contrast CT or MRI scan of the brain, bone scan, CT scan of the lungs to exclude other ipsilateral or contralateral parenchymal lesions, and contrast CT scan of the upper abdomen including entire liver and adrenals - No hepatomegaly or splenomegaly by physical examination or CT scan unless documentation of a benign cause - No pericardial effusion - No superior vena cava syndrome - No prior diagnosis of lung cancer --Prior/Concurrent Therapy-- Biologic therapy: No concurrent colony-stimulating factors Chemotherapy: - No prior chemotherapy for lung cancer - No concurrent chemotherapy for another condition (such as arthritis) Endocrine therapy: Not specified Radiotherapy: No prior radiotherapy for lung cancer Surgery: - See Disease Characteristics - No prior resection of primary tumor --Patient Characteristics-- Age: 18 and over Performance status: Karnofsky 90-100% (70-80% allowed if albumin at least 0.85 times lower limit of normal and weight loss no greater than 10% within 3 months before diagnosis) Hematopoietic: - WBC at least 4,000/mm3 OR - Granulocyte count at least 2,000/mm3 - Platelet count normal - Hemoglobin at least 10.0 g/dL (less than 8.5 g/dL allowed if no marrow involvement with tumor) Hepatic: - See Performance status - Bilirubin no greater than 1.5 times upper limit of normal (ULN)* - SGOT and SGPT no greater than 1.5 times ULN* * Unless documentation of a benign cause Renal: Creatinine clearance at least 50 mL/min Cardiovascular: - No myocardial infarction within the past 3 months - No active angina - No unstable arrhythmia - No congestive heart failure Pulmonary: - FEV1 at least 2.0 liters OR - Predicted postresection FEV1 at least 800 mL based on quantitative V/Q scan - DLCO at least 50% predicted (corrected for hemoglobin) if pneumonectomy planned or likely after induction chemotherapy Other: - No clinically significant hearing loss unless willing to accept the potential of further loss - No symptomatic peripheral neuropathy - No peptic ulcer disease under active treatment - No other medical illness not controllable by appropriate medical therapy - No other malignancy within the past 5 years except adequately treated basal cell or squamous cell skin cancer, carcinoma in situ of the cervix, or ductal or lobular carcinoma in situ of the breast - Not pregnant or nursing - Negative pregnancy test - Fertile patients must use effective contraception
Total Enrollment:
Location and Contact Information:
Overall Study Official:
WalterCurran, Study Chair, Radiation Therapy Oncology Group
Ireland Cancer Center
Cleveland, Ohio, 44106-5065
United States
Veterans Affairs Medical Center - Indianapolis (Roudebush)
Indianapolis, Indiana, 46202
United States
Medical College of Wisconsin
Milwaukee, Wisconsin, 53226
United States
Indiana University Cancer Center
Indianapolis, Indiana, 46202-5289
United States
CCOP - Cedar Rapids Oncology Project
Cedar Rapids, Iowa, 52403-1206
United States
Vanderbilt-Ingram Cancer Center
Nashville, Tennessee, 37232-6838
United States
CCOP - Carle Cancer Center
Urbana, Illinois, 61801
United States
CCOP - Ann Arbor Regional
Ann Arbor, Michigan, 48106
United States
CCOP - Toledo Community Hospital Oncology Program
Toledo, Ohio, 43623-3456
United States
Pretoria Academic Hospitals
Pretoria, , 0001
South Africa
University of Pittsburgh Cancer Institute
Pittsburgh, Pennsylvania, 15213-3489
United States
Hahnemann University Hospital
Philadelphia, Pennsylvania, 19102-1192
United States
CCOP - Green Bay
Green Bay, Wisconsin, 54301
United States
University of Rochester Cancer Center
Rochester, New York, 14642
United States
CCOP - Missouri Valley Cancer Consortium
Omaha, Nebraska, 68106
United States
Veterans Affairs Medical Center - Milwaukee (Zablocki)
Milwaukee, Wisconsin, 53295
United States
Additional Information:
Study ID Numbers: CDR0000063333; RTOG-9309,INT-0139
Study Start Date: June 1994
Record last reviewed: April 2003
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00002550
Other Bronchoalveolar Cell Lung Cancer Studies:
1. Lonafarnib and Gemcitabine in Treating Patients With Advanced Stage III, Stage IV, or Recurrent Non-Small Cell Lung Cancer
2. Carboplatin, Paclitaxel, and Radiation Therapy in Treating Patients With Stage III Non-small Cell Lung Cancer That Cannot Be Removed During Surgery
3. Chemotherapy Plus Radiation Therapy With or Without Surgery in Treating Patients With Stage IIIA Non-small Cell Lung Cancer
4. Positron Emission Tomography for Detecting Non-small Cell Lung Cancer
5. Combination Chemotherapy and Radiation Therapy in Treating Patients With Stage IIIB Non-Small Cell Lung Cancer
Related Studies:
Other bronchoalveolar cell lung cancer Clinical Trials
Other Michigan Clinical Trials
Other Ann Arbor Clinical Trials
Chemotherapy Plus Radiation Therapy With or Without Surgery in Treating Patients With Stage IIIA Non-small Cell Lung Cancer
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