Gated Intensity Modulated Radiation Therapy and Concurrent Chemotherapy for Inoperable NSCLC

Stopped early · Phase 1

Conditions studied: Non-small Cell Lung Cancer

In brief

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

Key facts

Study ID

NCT00692380

Run by

Virginia Commonwealth University

People needed

28

Starts

2006-06-01

Expected to finish

2010-06-01

Last updated by the study team

2016-05-02

Who can join

Age: any. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• Massey Cancer Center — Richmond, Virginia, United States

Full record on ClinicalTrials.gov

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