Status:
COMPLETED
Paclitaxel, Carboplatin, and Radiation Therapy in Treating Patients Who Are Undergoing Surgery for Stage III Non-Small Cell Lung Cancer
Lead Sponsor:
Radiation Therapy Oncology Group
Collaborating Sponsors:
National Cancer Institute (NCI)
Conditions:
Lung Cancer
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
RATIONALE: Drugs used in chemotherapy, such as paclitaxel and carboplatin, work in different ways to stop tumor cells from dividing so they stop growing or die. Radiation therapy uses high-energy x-ra...
Detailed Description
OBJECTIVES: * Determine the mediastinal node clearance rate in patients with stage IIIA or IIIB non-small cell lung cancer treated with neoadjuvant induction chemoradiotherapy comprising paclitaxel, ...
Eligibility Criteria
Inclusion
- Patients with Stage IIIA (T1-3 N2) or Stage IIIB (N3, excluding supraclavicular involvement) non-small cell lung cancer documented by biopsy or cytology (Pancoast tumors are eligible if pathologic evidence of mediastinal nodal disease is present);
- Disease must be measurable;
- Mediastinal lymph nodes must be proven positive by pathologic review. All patients must undergo mediastinoscopy, thoracoscopy, Chamberlain procedure, or transbronchial needle aspirate to evaluate extent of nodal involvement. Any lymph node assessed by mediastinoscopy and found to be positive will be defined as N2 disease;
- Patients ≥ 18 years of age;
- Life expectancy ≥ 6 months;
- Zubrod performance status 0- 1 (See Appendix II);
- Pretreatment laboratory values must be as follows: White blood cell count (WBC) count: ≥ 3,000/mm\^3; Absolute granulocyte count: ≥ 1,500/mm\^3; Platelets: ≥ 100,000/mm3; Total bilirubin: ≤ 1.5 x institutional upper limit of normal (ULN); Serum creatinine: ≤ 1.5 x institutional ULN; Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤ 2.5 x institutional ULN; serum albumin: ≥ 3.0 g/dL
- Baseline forced expiratory volume (FEV1) must be at least 2.0 liters; if less than 2.0 then V/Q scan is required and projected post-operative FEV1 must be \> 800 cc based on the following formula using the quantitative Ventilation/perfusion (V/Q) scan: FEV1 = FEV1 x % perfusion to uninvolved lung from quantitative lung V/Q scan report.
- Patient evaluation and acceptance by thoracic surgery, medical oncology, and radiation oncology; patient must be a potential surgical candidate prior to the initiation of therapy;
- Women of childbearing potential and male participants must practice an effective method of contraception during the study;
- Pretreatment evaluations required for eligibility include:
- A complete medical history \& physical examination to include Zubrod performance status, neurologic assessment, recent weight loss, usual weight, concurrent non-malignant disease and therapy;
- Location, type, and size of measurable lesion must be recorded prior to treatment;
- Complete blood count (CBC) with differential, platelet count, electrolytes, and Mg++ within 14 days prior to study entry;
- Twelve-channel serum multiple analysis (SMA-12): Total protein, Albumin, Calcium, Glucose, Blood urea nitrogen (BUN), Creatinine, Alkaline Phosphatase, Lactate dehydrogenase (LDH), Total Bilirubin, serum glutamic oxaloacetic transaminase (SGOT) and serum glutamic pyruvic transaminase (SGPT) within 14 days prior to study entry;
- Women of childbearing potential must have a negative pre-study serum or urine pregnancy test within 14 days prior to study entry.
- Mediastinoscopy, thoracoscopy, Chamberlain procedure, or bronchoscopy with transbronchial needle aspirate to evaluate the extent of lymph node involvement;
- Computed tomography (CT) scan of the chest to include liver, and adrenal glands within 6 weeks prior to study entry;
- Positron emission tomography (PET) scan within 8 weeks prior to study entry. Any suspicious areas outside of the local regional disease requires documented evaluation of these findings to exclude metastatic disease;
- CT scan or magnetic resonance imaging (MRI) of the brain within 6 weeks prior to study entry;
- Electrocardiogram (EKG) and pulmonary function tests including forced vital capacity (FVC), FEV-1, and diffusing capacity of carbon monoxide (DLCO), within 8 weeks prior to study entry; V/Q scan, if applicable, within 8 weeks prior to study entry.
- Patients must sign a study-specific informed consent prior to study entry.
Exclusion
- Small cell lung cancer; distant metastatic disease;
- Evidence of clinical or radiographic supraclavicular lymph node involvement;
- Bronchioalveolar carcinoma with lobar or multilobar involvement;
- Unintentional weight loss \> 5% within 6 months prior to study entry, or Zubrod performance status 2 or greater;
- Primary tumor location prevents delivery of 60 Gy and simultaneously limiting spinal cord dose to 48 Gy;
- Patients with malignant pleural effusion;
- Clinically evident superior vena cava syndrome;
- Prior systemic chemotherapy or radiation therapy to the thorax;
- Patients with known hypersensitivity to Cremophor EL;
- Patients receiving other investigational therapy;
- Pregnant or lactating women are ineligible, as treatment involves unforeseeable risks to the participant and to the embryo or fetus;
- Patients with an active serious infection or other serious underlying medical condition that would impair their ability to complete protocol treatment;
- Dementia or significantly altered mental status that would prohibit the understanding and/or giving of informed consent.
Key Trial Info
Start Date :
September 1 2004
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 16 2016
Estimated Enrollment :
60 Patients enrolled
Trial Details
Trial ID
NCT00096226
Start Date
September 1 2004
End Date
May 16 2016
Last Update
September 18 2019
Active Locations (22)
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1
Arizona Oncology Services Foundation
Phoenix, Arizona, United States, 85013
2
Virginia G. Piper Cancer Center at Scottsdale Healthcare - Shea
Scottsdale, Arizona, United States, 85260
3
USC/Norris Comprehensive Cancer Center and Hospital
Los Angeles, California, United States, 90089-9181
4
Mayo Clinic - Jacksonville
Jacksonville, Florida, United States, 32224