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Video-Assisted Surgery Followed by Radiation Therapy in Treating Patients With Stage I Non-small Cell Lung Cancer and Poor Heart and Lung Function Clinical Trials Facts presented on Clinical Trials Search isn't designed to be a substitute for proven healthcare advice, calls or treatment using a real mD. We aren't mDs. Always confer with your physician on Video-Assisted Surgery Followed by Radiation Therapy in Treating Patients With Stage I Non-small Cell Lung Cancer and Poor Heart and Lung Function conditions. Clinical Trials Search.org is a website dedicated to listing clinical research studies in human subjects. Video-Assisted Surgery Followed by Radiation Therapy in Treating Patients With Stage I Non-small Cell Lung Cancer and Poor Heart and Lung Function Clinical research trials and Video-Assisted Surgery Followed by Radiation Therapy in Treating Patients With Stage I Non-small Cell Lung Cancer and Poor Heart and Lung Function healthcare trials happen in a lot of of localities across the United States of America. A clinical trial or clinical study is a research project with human volunteer subjects. Clinical drug trials and pharmaceutical clinical trials generally measure the potency of new drugs. The aim of the studies / undertakings is to answer particular human medical questions. Clinical trials are a popular manner for doctors, government agencies, and private sector corporations to discover remedies for all kinds of circumstances, such as Video-Assisted Surgery Followed by Radiation Therapy in Treating Patients With Stage I Non-small Cell Lung Cancer and Poor Heart and Lung Function. Video-Assisted Surgery Followed by Radiation Therapy in Treating Patients With Stage I Non-small Cell Lung Cancer and Poor Heart and Lung Function Clinical Trials and other clinical trials allow volunteers to get healthcare treatment alternatives before they are available to the general public. Most times the participants receive treatment for without cost, and occasionally they are paid for their time. Sometimes there is a cost for a Video-Assisted Surgery Followed by Radiation Therapy in Treating Patients With Stage I Non-small Cell Lung Cancer and Poor Heart and Lung Function clinical trial. Human subjects often receive the most effective healthcare possible for their Video-Assisted Surgery Followed by Radiation Therapy in Treating Patients With Stage I Non-small Cell Lung Cancer and Poor Heart and Lung Function condition. Risks are a reality, nonetheless, and may include more or frequent dr. calls, healthcare hazards (perhaps life-threatening), and/or the treatment being ineffective. Trials are federally governed with rigorous guidelines to protect clinical trials subjects.
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Home > "V" Clinical Trials Conditions > Video-Assisted Surgery Followed by Radiation Therapy in Treating Patients With Stage I Non-small Cell Lung Cancer and Poor Heart and Lung Function  Video-Assisted Surgery Followed by Radiation Therapy in Treating Patients With Stage I Non-small Cell Lung Cancer and Poor Heart and Lung Function
Video-Assisted Surgery Followed by Radiation Therapy in Treating Patients With Stage I Non-small Cell Lung Cancer and Poor Heart and Lung Function
For Condition: stage 1 non-small cell lung cancer,squamous cell lung cancer,large cell lung cancer,adenocarcinoma of the lung,bronchoalveolar cell lung cancer
Status: Completed
Sponsor(s): Cancer and Leukemia Group B , National Cancer Institute (NCI),Eastern Cooperative Oncology Group
Synopsis: RATIONALE: Video-assisted surgery followed by radiation therapy may be an effective treatment in patients whose poor heart and lung function make them high risk for standard surgery. PURPOSE: Phase II trial to study the effectiveness of video-assisted surgery followed by radiation therapy in treating patients with stage I non-small cell lung cancer and poor heart and lung function.
Details: OBJECTIVES: - Determine the feasibility of video-assisted thoracoscopic wedge resection (VAR) followed by radiotherapy in patients with stage I non-small cell lung cancer and cardiopulmonary dysfunction. - Determine the incidence of locoregional recurrence in patients treated with this regimen. - Determine the overall and disease-free survival in patients treated with this regimen. - Determine the technical feasibility of ipsilateral lymph node sampling and complete resection with VAR in these patients. - Determine the incidence of conversion to open thoracotomy in these patients. - Determine the short- and long-term complications associated with VAR in these patients. - Determine the toxicity of adjuvant radiotherapy after VAR in these patients. OUTLINE: This is a multicenter study. Patients undergo video-assisted thoracoscopic wedge resection. Surgeons attempt sampling and identification of all ipsilateral, mediastinal, and hilar lymph nodes. When accessible, lobar lymph nodes must also be sampled. If the tumor margins are positive, further resection of the margins must be attempted. Open thoracotomy may be required for technical reasons. Eligible patients begin radiotherapy 2-8 weeks postoperatively. Patients with complete resection undergo radiotherapy 5 days a week for 5.6 weeks. Patients with incomplete resection undergo radiotherapy 5 days a week for 6.6 weeks. Patients are followed every 3 months for 2 years, every 6 months for 3 years, and then annually thereafter. PROJECTED ACCRUAL: Approximately 66 patients will be accrued for this study within approximately 22 months.
Eligibility:
Study Type: Interventional, Treatment
Minimum Age/Maximum Age: 18 Years/
Genders: Both
Protocol Entry Criteria: DISEASE CHARACTERISTICS: - Known or suspected, single, peripheral, stage T1 N0 M0 lung tumor - Tumor must not be identifiable by bronchoscopy - Bronchoscopically visible cancer or bronchial distortions considered related to tumor - Positive cytology by bronchoscopy allowed if no gross abnormality visible - Mediastinoscopy required for nodes greater than 1 cm - No pleural effusions - No metastatic or N2 disease on CT scan - Lesion must be accessible for video-assisted thoracoscopic wedge resection - High cardiopulmonary risk for thoracotomy with at least 1 of the following criteria: - FEV1 less than 40% predicted - DLCO less than 50% predicted - Supplemental oxygen requirement - Chronic PaCO2 greater than 45 mm Hg - Maximum oxygen consumption (VO2 max) less than 15 mL/kg/min - Patients who appear at high risk for non-pulmonary reasons (e.g., patients who are elderly or with renal or cardiac failure) may be eligible only if VO2 max or other criteria above are met - Eligible for radiotherapy after completion of wedge resection if histologic documentation of non-small cell lung cancer, including any of the following subtypes: - Squamous cell carcinoma - Adenocarcinoma - Bronchoalveolar cell - Large cell anaplastic carcinoma - Cytology from bronchial washings and transthoracic needle aspiration not acceptable PATIENT CHARACTERISTICS: Age: - 18 and over Performance status: - 0-2 Hematopoietic: - Not specified Hepatic: - Not specified Renal: - See Disease Characteristics Cardiovascular: - See Disease Characteristics Pulmonary: - See Disease Characteristics Other: - No other malignancy within the past 5 years except nonmelanomatous skin cancer or carcinoma in situ of the cervix - Weight loss no greater than 10% within the past 6 months PRIOR CONCURRENT THERAPY: Biologic therapy - Not specified Chemotherapy - Not specified Endocrine therapy - Not specified Radiotherapy - No prior thoracic irradiation Surgery - Not specified
Total Enrollment:
Location and Contact Information:
Overall Study Official:
HaniShennib, Study Chair, Montreal General Hospital
CCOP - Metro-Minnesota
St. Louis Park, Minnesota, 55416
United States
MBCCOP - University of New Mexico HSC
Albuquerque, New Mexico, 87131
United States
Westmead Hospital
Westmead, New South Wales, 2145
Australia
CCOP - MainLine Health
Wynnewood, Pennsylvania, 19096
United States
Penn State Cancer Institute at Milton S. Hershey Medical Center
Hershey, Pennsylvania, 17033-0850
United States
Drexel University Hospital
Philadelphia, Pennsylvania, 19102-1192
United States
CCOP - Colorado Cancer Research Program, Incorporated
Denver, Colorado, 80224
United States
Beth Israel Deaconess Medical Center
Boston, Massachusetts, 02215
United States
Midlands Cancer Center at Midlands Community Hospital
Papillion, Nebraska, 68128-4157
United States
Iowa Lutheran Hospital
Des Moines, Iowa, 50316-2301
United States
Mercy Cancer Center at Mercy Medical Center-Des Moines
Des Moines, Iowa, 50314
United States
San Juan City Hospital
San Juan, , 00936-7344
Puerto Rico
Instituto de Enfermedades Neoplasicas
Lima, , 34
Peru
CCOP - St. Vincent Hospital Cancer Center, Green Bay
Green Bay, Wisconsin, 54307-3453
United States
Hillman Cancer Center at University of Pittsburgh Cancer Institute
Pittsburgh, Pennsylvania, 15236
United States
John Stoddard Cancer Center at Iowa Methodist Medical Center
Des Moines, Iowa, 50309
United States
Additional Information:
Study ID Numbers: CDR0000063987; CALGB-9335,ECOG-C9335
Study Start Date:
Record last reviewed: April 2004
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00002624
Other Adenocarcinoma Of The Lung Studies:
1. Combination Chemotherapy Plus Radiation Therapy With or Without Gefitinib in Treating Patients With Unresectable Stage III Non-Small Cell Lung Cancer
2. Combination Chemotherapy, Gefitinib, and Radiation Therapy in Treating Patients With Stage III Non-Small Cell Lung Cancer
3. Gefitinib in Treating Patients With Stage IIIB or Stage IV Non-Small Cell Lung Cancer
4. Gemcitabine Plus Docetaxel or Irinotecan in Treating Patients With Stage IIIB or Stage IV Non-small Cell Lung Cancer
5. Cetuximab, Paclitaxel, Carboplatin, and Radiation Therapy in Treating Patients With Unresectable Stage IIIA or Stage IIIB Non-Small Cell Lung Cancer
Related Studies:
Other adenocarcinoma of the lung Clinical Trials
Other Pennsylvania Clinical Trials
Other Philadelphia Clinical Trials
Video-Assisted Surgery Followed by Radiation Therapy in Treating Patients With Stage I Non-small Cell Lung Cancer and Poor Heart and Lung Function
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