High-Dose or Standard-Dose Radiation Therapy and Chemotherapy With or Without Cetuximab in Treating Patients With Newly Diagnosed Stage III Non-Small Cell Lung Cancer That Cannot Be Removed by Surgery

Completed · Phase 3

Conditions studied: Lung Cancer, Radiation Toxicity

In brief

RATIONALE: Radiation therapy uses high-energy x-rays to kill tumor cells. Drugs used in chemotherapy, such as paclitaxel, carboplatin work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Monoclonal antibodies, such as cetuximab can block tumor growth in different ways. Some block the ability of tumor cells to grow and spread. Others find tumor cells and help kill them or carry tumor-killing substances to them. It is not yet known whether high-dose radiation therapy is more effective than standard-dose radiation therapy when given together with combination chemotherapy with or without cetuximab in treating patients with non-small cell lung cancer. PURPOSE: This randomized phase III trial is studying high-dose or standard-dose radiation therapy given together with chemotherapy with or without cetuximab to see how well they work in treating patients with newly diagnosed stage III non-small cell lung cancer that cannot be removed by surgery.

Key facts

Study ID

NCT00533949

Run by

Radiation Therapy Oncology Group

People needed

544

Starts

2007-11-01

Expected to finish

2022-05-20

Last updated by the study team

2022-06-21

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Pathologically proven (either histologic or cytologic) diagnosis of Stage IIIA or IIIB non-small cell lung cancer (NSCLC); excluding patients with N3 disease based on supraclavicular or contralateral hilar adenopathy, [according to American Joint Committee on Cancer (AJCC) Staging, 6th edition; see appendix III] within 12 weeks of registration; patients who present with N2 or N3 disease and an undetectable NSCLC primary tumor also are eligible.
• Patients must be considered unresectable or inoperable; Note: Patients who have had a nodal recurrence after surgery for an early-stage NSCLC are eligible if the following criteria are met:
• Nodal recurrence must be N1 or N2; N3 is not eligible.
• The initial primary must have been staged as T1-2, N0, M0.
• The node must be biopsied within 12 weeks of registration.
• The node must be measurable.
• The patient must not have received prior chemotherapy or radiation for this lung cancer.
• Prior curative surgery must have been at least 6 months prior to the nodal recurrence.
• The exception to a prior invasive malignancy does not apply to the initial lung primary.
• Stage III A or B disease, including no distant metastases, based upon the following minimum diagnostic workup are acceptable:
• History/physical examination, including documentation of height, weight, body surface area (BSA), and vital signs within 8 weeks prior to registration;
• Computed tomographic (CT)/Magnetic Resonance Imaging (MRI) imaging of the lung and upper abdomen through the adrenal glands within 6 weeks prior to registration;
• An MRI of the brain with contrast (or CT with contrast if MRI is medically contraindicated) within 6 weeks prior to registration; Note: The use of intravenous contrast is required for the MRI or CT. An MRI without contrast is only permitted if the patient has a contrast allergy.
• Whole-body fluorodeoxyglucose (FDG) - Positron Emission Tomography(PET) or PET/CT or if no PET is available, a bone scan is required within 6 weeks prior to registration; Note: If a PET is done that shows clear adrenals and lungs, then a CT scan of chest only is permitted.
• If a pleural effusion is present, the following criteria must be met to exclude malignant involvement (incurable T4 disease):
• When pleural fluid is visible on both the CT scan and on a chest x-ray, a pleuracentesis is required to confirm that the pleural fluid is cytologically negative.
• Exudative pleural effusions are excluded, regardless of cytology;
• Effusions that are minimal (i.e. not visible on chest x-ray) that are too small to safely tap are eligible.
• Patients must have measurable or evaluable disease.
• Patients with post-obstructive pneumonia are eligible.
• Patients must be at least 3 weeks from prior thoracotomy (if performed).
• Zubrod Performance Status 0-1;
• Age ≥ 18;
• Pulmonary function tests (PFTs) including forced expiratory volume in one second (FEV1) within 12 weeks prior to registration; for FEV1, the best value obtained pre- or post bronchodilator must be ≥ 1.2 liters/second or ≥ 50% predicted.
• Complete blood count (CBC)/differential obtained within 2 weeks prior to registration on study, with adequate bone marrow function defined as follows:

You may not qualify if…

• N3 supraclavicular disease;
• Greater than minimal, exudative, or cytologically positive pleural effusions;
• Involved contralateral hilar nodes (i.e. greater than 1.5 cm on short axis or positive on PET scan);
• ≥ 10% weight loss within the past month;
• Prior invasive malignancy (except non-melanomatous skin cancer) unless disease free for a minimum of 3 years; non-invasive conditions such as carcinoma in situ of the breast, oral cavity, or cervix are all permissible.
• Prior systemic chemotherapy for the study cancer; note that prior chemotherapy for a different cancer is allowable.
• Prior radiotherapy to the region of the study cancer that would result in overlap of radiation therapy fields;
• Prior therapy that specifically and directly targets the epidermal growth factor receptor (EGFR) pathway;
• Prior severe infusion reaction to a monoclonal antibody;
• Severe, active co-morbidity, defined as follows:
• Significant history of uncontrolled cardiac disease; i.e., uncontrolled hypertension, unstable angina, myocardial infarction within the last 6 months, uncontrolled congestive heart failure, and cardiomyopathy with decreased ejection fraction.
• Transmural myocardial infarction within the last 6 months;
• Acute bacterial or fungal infection requiring intravenous antibiotics at the time of registration;
• Chronic Obstructive Pulmonary Disease exacerbation or other respiratory illness requiring hospitalization or precluding study therapy within 30 days before registration;
• Hepatic insufficiency resulting in clinical jaundice and/or coagulation defects;
• Acquired Immune Deficiency Syndrome (AIDS) based upon current Centers for Disease Control and Prevention (CDC) definition; note, however, that human immunodeficiency virus (HIV) testing is not required for entry into this protocol. The need to exclude patients with AIDS from this protocol is necessary because the treatments involved in this protocol may be significantly immunosuppressive. Protocol-specific requirements may also exclude immuno-compromised patients.
• Pregnancy or women of childbearing potential and men who are sexually active and not willing/able to use medically acceptable forms of contraception; this exclusion is necessary because the treatment involved in this study may be significantly teratogenic.
• Any history of allergic reaction to paclitaxel or other taxanes, or to carboplatin;
• Uncontrolled neuropathy grade 2 or greater regardless of cause.

Where it is running

• Mayo Clinic Scottsdale — Scottsdale, Arizona, United States
• Arizona Oncology - Tucson — Tucson, Arizona, United States
• Mercy Cancer Center at Mercy San Juan Medical Center — Carmichael, California, United States
• Enloe Cancer Center at Enloe Medical Center — Chico, California, United States
• Cancer Care Center at John Muir Health - Concord Campus — Concord, California, United States
• Saint Agnes Cancer Center at Saint Agnes Medical Center — Fresno, California, United States
• Rebecca and John Moores UCSD Cancer Center — La Jolla, California, United States
• Memorial Medical Center — Modesto, California, United States
• St. Joseph Hospital Regional Cancer Center - Orange — Orange, California, United States
• Feather River Hospital Cancer Center — Paradise, California, United States
• Radiation Oncology Center - Roseville — Roseville, California, United States
• Radiological Associates of Sacramento Medical Group, Incorporated — Sacramento, California, United States
• University of California Davis Cancer Center — Sacramento, California, United States
• UCSF Helen Diller Family Comprehensive Cancer Center — San Francisco, California, United States
• Saint Helena Hospital — St. Helena, California, United States
• Stanford Cancer Center — Stanford, California, United States
• Penrose Cancer Center at Penrose Hospital — Colorado Springs, Colorado, United States
• Swedish Medical Center — Englewood, Colorado, United States
• Poudre Valley Radiation Oncology — Fort Collins, Colorado, United States
• North Suburban Medical Center — Thornton, Colorado, United States
• CCOP - Christiana Care Health Services — Newark, Delaware, United States
• Washington Cancer Institute at Washington Hospital Center — Washington D.C., District of Columbia, United States
• Broward General Medical Center Cancer Center — Fort Lauderdale, Florida, United States
• University of Florida Shands Cancer Center — Gainesville, Florida, United States
• UAB Comprehensive Cancer Center — Birmingham, Alabama, United States

Full record on ClinicalTrials.gov

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