Combination Chemotherapy and Radiation Therapy With or Without Gefitinib in Treating Patients With Stage III Non-Small Cell Lung Cancer That Cannot Be Removed By Surgery

Completed · Phase 3 · Has a placebo group

Conditions studied: Adenocarcinoma of the Lung, Bronchoalveolar Cell Lung Cancer, Large Cell Lung Cancer, Squamous Cell Lung Cancer, Stage IIIA Non-small Cell Lung Cancer, Stage IIIB Non-small Cell Lung Cancer

In brief

Randomized phase III trial to compare the effectiveness of combination chemotherapy plus radiation therapy with or without gefitinib in treating unresectable stage III non-small cell lung cancer. Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Radiation therapy uses high-energy x-rays to damage tumor cells. Biological therapies such as gefitinib may interfere with the growth of the tumor cells and slow the growth of tumors. It is not yet known whether combination chemotherapy plus radiation therapy is more effective with or without gefitinib in treating non-small cell lung cancer

Key facts

Study ID

NCT00020709

Run by

National Cancer Institute (NCI)

People needed

840

Starts

2001-06-01

Last updated by the study team

2013-02-27

Who can join

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

You may qualify if…

• Either histologic or cytologic proof of a newly diagnosed single, primary bronchogenic non-small cell lung cancer is required (adenocarcinoma, non-lobar and non-diffuse bronchioloalveolar cell carcinoma, large cell carcinoma, or squamous cell carcinoma); a biopsy with histology is preferred, but cytology is allowed; histology or cytology from involved mediastinal or supraclavicular lymph nodes alone will be allowed if a separate distal primary lesion is clearly evident on radiographs (i.e., a second biopsy will not be required)
• Patients with brain metastases are ineligible; all patients must have a pretreatment CT or MRI scan of the brain to evaluate for CNS disease within 42 days prior to registration
• Patients with two or more parenchymal lesions on same or opposite sides of the lung are ineligible
• Patients must have unresectable Stage IIIA (N2) or Stage IIIB disease and also satisfy the following criteria:
• Unresectable Stage IIIA (N2) patients must satisfy the criteria:
• N2 mediastinal lymph nodes must be multiple and/or bulky on CT scan or X-ray, such that, in the opinion of the treating investigator, the patient is not a candidate for induction chemotherapy or chemoradiotherapy followed by surgical resection
• If Stage IIIA (N2), the N2 status must be documented by any one of the following methods:
• Histologic or cytologic proof of N2 disease by exploratory thoracotomy, thoracoscopy, mediastinoscopy, mediastinotomy, Chamberlain procedure, Wang needle biopsy, or fine needle aspiration (FNA) under bronchoscopic or CT guidance or other method
• Node positivity by FDG-PET scan
• Nodes > 3 cm on CT scan
• Paralyzed left true vocal cord with separate left lung primary distinct from AP window nodes on CT scan
• Stage IIIB patients must satisfy the following criteria; documentation of N3 or T4 status may be obtained by one or more of the following:
• Pathologically documented or radiographically documented positive N3 nodes; patients with positive supraclavicular or scalene lymph nodes must not have disease extending up into the cervical region
• Fine needle aspiration, core needle biopsy or excisional biopsy or supraclavicular N3 nodes
• Biopsy of contralateral mediastinal N3 nodes by mediastinoscopy, mediastinotomy or thoracotomy
• Fine needle aspiration, core needle or Wang needle biopsy under Ct or bronchoscopic fluoroscopic guidance of enlarged contralateral N3 mediastinal nodes
• Contralateral mediastinal nodes > 3 cm on CT scan
• Node positivity by FDG-PET scan
• Right sided primary with paralyzed left true vocal cord OR
• Any of the following T4 lesions: Tumor of any size that invades any of the following: mediastinum, heart, great vessels, trachea, esophagus, vertebral body or carina
• Written documentation of type of T4 extent by attending surgeon on either the operative report or as an addendum in the notes section of the prestudy form if patient has had an exploratory thoracotomy or thoracoscopy
• T4 involvement of trachea or carina by direct bronchoscopic visualization, documented on bronchoscopy report or as an addendum in the notes section of the prestudy form
• T4 involvement of heart, esophagus, aorta or vertebral body documented by CT scan, MRI or transesophageal ultrasound
• T4 involvement of the mediastinum may also be accepted by CT or MRI criteria if, in absence of the above organ involvement, there is soft tissue extension directly into the mediastinal space; radiographic criteria for involvement of main pulmonary artery or vein is allowed only if there is a mediastinal soft tissue mass
• Patients must not have malignant pleural effusions; NOTE: the only exception is pleural effusion only on CT scan (and not visible on CXR) OR deemed too small to tap

Where it is running

• Southwest Oncology Group (SWOG) Research Base — San Antonio, Texas, United States

Full record on ClinicalTrials.gov

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