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Radiation Therapy Using 3-Dimensional Treatment Planning in Patients With Non-small Cell Lung Cancer



Radiation Therapy Using 3-Dimensional Treatment Planning in Patients With Non-small Cell Lung Cancer

For Condition: stage 1 non-small cell lung cancer,stage 2 non-small cell lung cancer,stage 3A non-small cell lung cancer,stage 3B non-small cell lung cancer
Status: No longer recruiting
Sponsor(s): Memorial Sloan-Kettering Cancer Center ,
Synopsis: RATIONALE: Radiation therapy uses high-energy x-rays to damage tumor cells. Computer systems that allow doctors to create a 3-dimensional picture of the tumor in order to plan treatment may result in more effective radiation therapy. PURPOSE: Phase I trial to study the effectiveness of high-dose radiation therapy planned using a 3-dimensional picture of the tumor in treating patients who have stage I, stage II, or stage III non-small cell lung cancer.
Details: OBJECTIVES: - Determine the maximum dose of external beam irradiation deliverable using conformal 3-dimensional treatment planning in patients with non-small cell lung cancer. - Determine the feasibility and efficacy of 3-dimensional treatment planning in delivering high doses of external beam radiotherapy to these patients. - Determine whether computer-generated dose-volume histograms and normal tissue complication probability models can predict the degree of pulmonary toxicity resulting from external beam radiotherapy. - Determine the relationship between dose of external beam radiotherapy and the degree of pulmonary function change. OUTLINE: This is a dose escalation study. Patients undergo 3-dimensional conformal external beam radiotherapy 5 days a week for 8-10 weeks. Cohorts of 10 patients receive escalating doses of radiotherapy until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose at which no more than 20% of patients experience dose-limiting toxicity. Patients are followed at 1 month and then every 4 months thereafter. PROJECTED ACCRUAL: A total of 60-70 patients will be accrued for this study within 3 years.
Eligibility:
Study Type:
  Interventional, Treatment
Minimum Age/Maximum Age: 18 Years/
Genders: Both
Protocol Entry Criteria: DISEASE CHARACTERISTICS: - Histologically or cytologically confirmed non-small cell lung cancer - Clinical stage T1-4, N0-2, M0 - Clinical stage T1-2, N0-1 must be medically inoperable - No distant metastases on history and physical exam, CBC, screening profile, CT or MRI of brain, CT of chest and abdomen (including adrenals and liver), and bone scan - No pleural effusions - Atelectasis not clearly distinguishable from tumor mass allowed provided all tumor and atelectasis together represent a volume that can be safely treated to the total dose delivered to gross disease - Diffuse pulmonary infiltrates thought to represent benign disease allowed only if representative lesion samples are proven by biopsy or cytology not to contain cancer - No diffuse bronchoalveolar carcinoma PATIENT CHARACTERISTICS: Age: - 18 and over Performance status: - Karnofsky 70-100% Life expectancy: - Not specified Hematopoietic: - Not specified Hepatic: - Not specified Renal: - Not specified Other: - No other malignancy within the past 5 years except nonmelanomatous skin cancer or noninvasive cervical carcinoma - No other medical illness that cannot be adequately controlled with appropriate therapy or that is considered severe enough to preclude a radical treatment approach PRIOR CONCURRENT THERAPY: Biologic therapy - No prior biologic therapy for lung cancer Chemotherapy - No prior chemotherapy for lung cancer Endocrine therapy - No prior endocrine therapy for lung cancer Radiotherapy - No prior radiotherapy for lung cancer Surgery - No prior surgery for lung cancer
Total Enrollment: 

Location and Contact Information:

Overall Study Official:
KennethRosenzweig,  Study Chair,  Memorial Sloan-Kettering Cancer Center

Memorial Sloan-Kettering Cancer Center
New York City,  New York,  10021
United States
 


Additional Information:
Study ID Numbers:
  CDR0000077300;  MSKCC-91121,NCI-V91-0198
Study Start Date: 
Record last reviewed: February 2004
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00002484

Other Stage 3b Non-Small Cell Lung Cancer Studies:
1. Combination Chemotherapy, Gefitinib, and Radiation Therapy in Treating Patients With Stage III Non-Small Cell Lung Cancer

2. Combination Chemotherapy Plus Radiation Therapy in Treating Patients With Stage III Non-small Cell Lung Cancer

3. High-Dose 3-Dimensional Conformal Radiation Therapy in Treating Patients With Inoperable Stage I, Stage II, or Stage IIIA Non-Small Cell Lung Cancer

4. Combination Chemotherapy in Treating Patients With Stage I, II, or IIIA Non-small Cell Lung Cancer That Has Been Surgically Removed

5. Paclitaxel, Carboplatin, and Radiation Therapy With or Without Adjuvant Paclitaxel and Carboplatin in Treating Patients With Stage II or Stage III Unresectable Non-Small Cell Lung Cancer

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Radiation Therapy Using 3-Dimensional Treatment Planning in Patients With Non-small Cell Lung Cancer

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