Expired Study
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Richmond, Virginia 23219


Purpose:

Radiation therapy technology that allows increased radiation dose to the tumor while sparing healthy tissue will improve the balance between complications and cure.


Study summary:

The primary objective is to establish the maximum tolerated fractional dose (MTfD) of radiotherapy to a total dose of 78Gy using gated IMRT, delivered in single daily fractions that can be administered concurrently with Taxol® and carboplatin chemotherapy. Secondary objectives include: to evaluate the toxicity of concurrent Taxol® and carboplatin with gated IMRT; identify partial organ tolerance doses for lung and esophagus when treating with involved field thoracic 3D; estimate complete response rate as defined by PET performed 3 months after completion of all therapy.


Criteria:

Inclusion Criteria: - Patients with histologically-proven, by biopsy or cytology, unresectable lung cancer of the following histologic types: squamous cell carcinoma, adenocarcinoma, large cell carcinoma, non-small cell carcinoma, not otherwise specified. - Patient with AJCC Stage IIIA-IIIB, if all detectable tumor can be encompassed by radiation therapy fields, including both the primary tumor and the involved regional lymph nodes. - 18-fluoro-2-deoxyglucose positron emission tomography required for staging and image fusion for treatment planning. - Atelectasis, if present, must be less than one lung. - Patients must have granulocytes >1500/µl; platelets >100,000/µl; bilirubin < 1.5 mg/dl; AST(SGOT) < 2 ULN; serum creatinine < 2.0 mg/dl. - Zubrod Score 0-1. - FEV1 must be >1.0 L. - Patients must sign a study-specific informed consent form prior to study entry - Patients must have measurable disease on the planning CT. - Patient must have a completed the IMRT plan and the attending physician must have reviewed and approved the dose volume histograms as follows (based on treatment planning to the Phase 4 dose level): total lung V20 < 30%, mean esophageal dose < 34 Gy, the esophageal V55 < 30%, the heart V40 < 50%. - No prior or concurrent malignancy except non-melanomatous skin cancer unless disease-free for one year or more; no prior lung cancer within last two years. - No prior RT to thorax. - No previous chemotherapy or previous biologic response modifiers for current lung cancer or within the past five (5) years. - No distant metastases or supraclavicular lymph node involvement or significant atelectasis. - No clinically significant pleural effusions, pericardial effusions or superior vena cava syndrome. Exclusion Criteria: - Undifferentiated small cell (oat cell or high grade neuroendocrine) carcinoma, any stage. - Stage I, II or IV NSCLC. - Complete tumor resection, recurrent disease, or those patients eligible for definitive surgery. - Concurrent malignancy except non-melanomatous skin cancer or prior cancer unless disease-free for one year or more. - Prior radiation therapy to the thorax. - Previous chemotherapy or previous biologic response modifiers for current lung cancer or within the past five (5) years. - Distant metastases or supraclavicular lymph node involvement, or atelectasis of an entire lung. - Patients who have not had the pre-treatment evaluations in Section 4.0 or evaluations performed > 8 weeks prior to study entry. - Patients with clinically significant pleural effusions, pericardial effusions or superior vena cava syndrome. - Prior lung cancer within the last two years. - Patients who have significant atelectasis and in whom the CT definition of the gross tumor volume(GTV) is difficult to determine. - Pregnant or lactating females. It is not known what effects this treatment may have on the developing fetus.


NCT ID:

NCT00692380


Primary Contact:

Principal Investigator
Elisabeth Weiss, M.D.
Massey Cancer Center


Backup Contact:

N/A


Location Contact:

Richmond, Virginia 23219
United States



There is no listed contact information for this specific location.

Site Status: N/A


Data Source: ClinicalTrials.gov

Date Processed: March 16, 2018

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