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High-Dose 3-Dimensional Conformal Radiation Therapy in Treating Patients With Inoperable Stage I, Stage II, or Stage IIIA Non-Small Cell Lung Cancer Clinical Trials Information presented on Clinical Trials Search is not designed to be a substitute for certified medical advice, trips or professional assistance with a real medical doctor. We aren't docs. Always confer with your doctor about High-Dose 3-Dimensional Conformal Radiation Therapy in Treating Patients With Inoperable Stage I, Stage II, or Stage IIIA Non-Small Cell Lung Cancer conditions. Clinical Trials Search.org is a website committed to listing clinical research studies in human subjects. High-Dose 3-Dimensional Conformal Radiation Therapy in Treating Patients With Inoperable Stage I, Stage II, or Stage IIIA Non-Small Cell Lung Cancer Clinical research trials and High-Dose 3-Dimensional Conformal Radiation Therapy in Treating Patients With Inoperable Stage I, Stage II, or Stage IIIA Non-Small Cell Lung Cancer health trials happen in many of cities across the US. A clinical trial or clinical study is a research project with human volunteer subjects. Clinical drug trials and pharmaceutical clinical trials generally measure the effectualness of new does drugs. The intention of the studies / projects is to figure out particular human healthcare questions. Clinical trials are a popular manner for doctors, government agencies, and private sector corporations to detect cures for all forms of circumstances, like High-Dose 3-Dimensional Conformal Radiation Therapy in Treating Patients With Inoperable Stage I, Stage II, or Stage IIIA Non-Small Cell Lung Cancer. High-Dose 3-Dimensional Conformal Radiation Therapy in Treating Patients With Inoperable Stage I, Stage II, or Stage IIIA Non-Small Cell Lung Cancer Clinical Trials and other clinical trials allow for volunteers to undergo medical treatment options before they are available to the general public. Most times the subjects get treatment for free of charge, and occasionally they are paid for their time. Occasionally there is a cost for a High-Dose 3-Dimensional Conformal Radiation Therapy in Treating Patients With Inoperable Stage I, Stage II, or Stage IIIA Non-Small Cell Lung Cancer clinical trial. Subjects frequently get the best healthcare possible for their High-Dose 3-Dimensional Conformal Radiation Therapy in Treating Patients With Inoperable Stage I, Stage II, or Stage IIIA Non-Small Cell Lung Cancer condition. Hazards are a reality, however, and could include more or frequent mD visits, health risks (possibly life-jeopardizing), and/or the treatment being ineffectual. Trials are federally regulated with exacting guidelines to protect clinical trials patients.
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Home > "H" Clinical Trials Conditions > High-Dose 3-Dimensional Conformal Radiation Therapy in Treating Patients With Inoperable Stage I, Stage II, or Stage IIIA Non-Small Cell Lung Cancer  High-Dose 3-Dimensional Conformal Radiation Therapy in Treating Patients With Inoperable Stage I, Stage II, or Stage IIIA Non-Small Cell Lung Cancer
High-Dose 3-Dimensional Conformal Radiation Therapy in Treating Patients With Inoperable Stage I, Stage II, or Stage IIIA Non-Small Cell Lung Cancer
For Condition: stage 2 non-small cell lung cancer,stage 3A non-small cell lung cancer,stage 1 non-small cell lung cancer
Status: Recruiting
Sponsor(s): EORTC Radiotherapy Cooperative Group ,
Synopsis: RATIONALE: Using computer systems that create a 3-dimensional picture of the tumor to plan treatment may enable doctors to provide more effective radiation therapy that will cause less damage to normal tissue. PURPOSE: Phase I trial to study the effectiveness of high-dose 3-dimensional conformal radiation therapy in treating patients who have inoperablestage I, stage II, or stage IIIA non-small cell lung cancer.
Details: OBJECTIVES: - Determine the optimal dose of high-dose 3-dimensional conformal radiotherapy in patients with inoperable stage I, II, or IIIA non-small cell lung cancer who are treated according to the total lung volume irradiated. - Determine the feasibility of this regimen, in terms of local control rates and incidence of distant metastases, in these patients. OUTLINE: This is an open-label, nonrandomized, dose-escalation, multicenter study. Patients are assigned to 1 of 3 strata according to the total lung volume irradiated (less than 25% vs 25-37% vs over 37%). - Stratum I: Patients undergo high-dose 3-dimensional (3-D) conformal radiotherapy 5 days a week for 6 weeks. - Stratum II: Patients undergo high-dose 3-D conformal radiotherapy 5 days a week for 5.5-7 weeks. - Stratum III: Patients undergo high-dose 3-D conformal radiotherapy 5 days a week for 5.5-6.5 weeks. Cohorts of 6-15 patients in each stratum receive escalating dose intensities of high-dose 3-D conformal radiotherapy (either by increasing the total dose or by shortening treatment time) until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose at which 2 of 6, 2 of 15, or 3 of 30 patients experience dose-limiting toxicity. Patients are followed at 1 month, at least every 2 months for 1 year, every 3 months for 1 year, and then every 6 months thereafter. PROJECTED ACCRUAL: A total of 54-135 patients (18-45 per stratum) will be accrued for this study.
Eligibility:
Study Type: Interventional, Treatment
Minimum Age/Maximum Age: /
Genders: Both
Protocol Entry Criteria: DISEASE CHARACTERISTICS: - Histologically or cytologically confirmed non-small cell lung cancer - Medically inoperable stage I or II disease - Stage III disease eligible provided the following are true: - No supraclavicular node involvement - No peripherally located lower lobe tumor AND contralateral upper mediastinal node involvement - No distant metastasis - No malignant pleural or pericardial effusion PATIENT CHARACTERISTICS: Age - Not specified Performance status - WHO 0-2 Life expectancy - Not specified Hematopoietic - Not specified Hepatic - Not specified Renal - Not specified Cardiovascular - No prior myocardial infarction - No prior complete bundle branch block - No other prior cardiovascular disease resulting in New York Heart Association class III or IV heart disease - No clinically significant cardiac arrhythmias - No congestive heart failure Pulmonary - FEV - at least 1.2 L OR - DLCO at least 60% Other - No other prior or concurrent malignancy except cured basal cell skin cancer or carcinoma in situ of the cervix - No intractable or uncontrolled infection - No psychological, familial, social, or geographical condition that would preclude study compliance and follow-up - Able to tolerate a course of radiotherapy PRIOR CONCURRENT THERAPY: Biologic therapy - Not specified Chemotherapy - At least 3 weeks since prior chemotherapy - No prior anthracyclines - No concurrent chemotherapy Endocrine therapy - Not specified Radiotherapy - No prior radiotherapy to the chest area Surgery - No prior therapeutic surgery to the chest area Other - No other prior therapy to the chest area
Total Enrollment:
Location and Contact Information:
Overall Study Official:
JacquesBernier, , Ospedale San Giovanni
Ospedale San Giovanni *Recruiting*
Bellinzona, , CH-6500
Switzerland
Recruiting Contact Person 41-91-811-91-57
Additional Information:
Study ID Numbers: CDR0000304729; EORTC-22994
Study Start Date:
Record last reviewed: May 2003
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00062335
Other Stage 2 Non-Small Cell Lung Cancer Studies:
1. Surgery With or Without Preoperative Chemotherapy in Treating Patients With Resectable Non-small Cell Lung Cancer
2. Diagnosis and Treatment Planning in Patients Suspected of Having Lung Cancer
3. Celecoxib and Radiation Therapy in Treating Patients With Locally Advanced Non-Small Cell Lung Cancer
4. Vaccine Therapy in Treating Patients With Non-Small Cell Lung Cancer
5. Radiofrequency Ablation During Surgery in Treating Patients With Non-Small Cell Lung Cancer
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High-Dose 3-Dimensional Conformal Radiation Therapy in Treating Patients With Inoperable Stage I, Stage II, or Stage IIIA Non-Small Cell Lung Cancer
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