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Clinical Trial Title
Cisplatin and Docetaxel With or Without Radiation Therapy in Treating Patients Who Are Undergoing Surgery for Newly Diagnosed Stage III Non-Small Cell Lung Cancer
Location and Contact Information
Moores UCSD Cancer Center
Location and Contact Information
University of California Davis Cancer Center
Location and Contact Information
USC/Norris Comprehensive Cancer Center and Hospital
Location and Contact Information
Front Range Cancer Specialists
Location and Contact Information
Memorial Hospital
Location and Contact Information
Poudre Valley Hospital
Location and Contact Information
CCOP - Christiana Care Health Services
Location and Contact Information
CCOP - Mount Sinai Medical Center
Location and Contact Information
Ella Milbank Foshay Cancer Center at Jupiter Medical Center
Location and Contact Information
Mayo Clinic - Jacksonville
Location and Contact Information
Watson Clinic, LLC
Location and Contact Information
CCOP - Atlanta Regional
Location and Contact Information
Northeast Georgia Medical Center
Location and Contact Information
Phoebe Cancer Center at Phoebe Putney Memorial Hospital
Location and Contact Information
Advocate Christ Medical Center
Location and Contact Information
Cancer Institute at St. John's Hospital
Location and Contact Information
Cancer Treatment Center at Pekin Hospital
Location and Contact Information
Cardinal Bernardin Cancer Center at Loyola University Medical Center
Location and Contact Information
Community Cancer Center
Location and Contact Information
Delnor Community Hospital - Geneva
Location and Contact Information
Oncology Hematology Associates of Central Illinois, PC - Peoria
Location and Contact Information
OSF St. Francis Medical Center
Location and Contact Information
Memorial Hospital of South Bend
Location and Contact Information
Reid Hospital & Health Care Services, Incorporated
Location and Contact Information
Genesis Regional Cancer Center at Genesis Medical Center
Location and Contact Information
Hematology Oncology Associates of the Quad Cities
Location and Contact Information
Markey Cancer Center at University of Kentucky Chandler Medical Center
Location and Contact Information
Frederick Memorial Hospital Regional Cancer Therapy Center
Location and Contact Information
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Location and Contact Information
St. Agnes Hospital Cancer Center
Location and Contact Information
Massachusetts General Hospital Cancer Center
Location and Contact Information
Bronson Methodist Hospital
Location and Contact Information
CCOP - Michigan Cancer Research Consortium
Location and Contact Information
University of Michigan Comprehensive Cancer Center
Location and Contact Information
Upper Michigan Cancer Center at Marquette General Hospital
Location and Contact Information
Mayo Clinic Cancer Center
Location and Contact Information
Siteman Cancer Center at Barnes-Jewish Hospital
Location and Contact Information
St. John's Regional Health Center
Location and Contact Information
St. John's Regional Medical Center
Location and Contact Information
Good Samaritan Cancer Center at Good Samaritan Hospital
Location and Contact Information
Methodist Cancer Center at Methodist Hospital - Omaha
Location and Contact Information
UNMC Eppley Cancer Center at the University of Nebraska Medical Center
Location and Contact Information
Valley Hospital - Ridgewood
Location and Contact Information
Faxton Regional Cancer Center
Location and Contact Information
NYU Cancer Institute at New York University Medical Center
Location and Contact Information
SUNY Upstate Medical University Hospital
Location and Contact Information
Duke Comprehensive Cancer Center
Location and Contact Information
FirstHealth Moore Regional Community Hospital Comprehensive Cancer Center
Location and Contact Information
Lenoir Memorial Cancer Center
Location and Contact Information
Leo W. Jenkins Cancer Center at ECU Medical School
Location and Contact Information
Arthur G. James Cancer Hospital and Solove Research Institute at Ohio State University
Location and Contact Information
Charles M. Barrett Cancer Center at University Hospital
Location and Contact Information
Oregon Health & Science University Cancer Institute
Location and Contact Information
Veterans Affairs Medical Center - Portland
Location and Contact Information
Albert Einstein Cancer Center
Location and Contact Information
Allegheny Cancer Center at Allegheny General Hospital
Location and Contact Information
Kimmel Cancer Center at Thomas Jefferson University - Philadelphia
Location and Contact Information
Lancaster General Hospital
Location and Contact Information
Penn State Cancer Institute at Milton S. Hershey Medical Center
Location and Contact Information
St. Luke's Hospital Cancer Center
Location and Contact Information
York Cancer Center at Apple Hill Medical Center
Location and Contact Information
CCOP - Greenville
Location and Contact Information
CCOP - Upstate Carolina
Location and Contact Information
Hollings Cancer Center at Medical University of South Carolina
Location and Contact Information
U.T. Cancer Institute at University of Tennessee Medical Center
Location and Contact Information
Medical City Dallas Hospital
Location and Contact Information
Simmons Comprehensive Cancer Center at University of Texas Southwestern Medical Center - Dallas
Location and Contact Information
CCOP - Virginia Mason Research Center
Location and Contact Information
Madigan Army Medical Center - Tacoma
Location and Contact Information
Swedish Cancer Institute at Swedish Medical Center - First Hill Campus
Location and Contact Information
Dean Medical Center - Madison
Location and Contact Information
Vince Lombardi Cancer Clinic - Green Bay at Aurora BayCare Medical Center
Location and Contact Information
Vince Lombardi Cancer Clinic - Sheboygan
Status Completed
Sponsors
Radiation Therapy Oncology Group
National Cancer Institute (NCI)
Southwest Oncology Group
Cancer and Leukemia Group B
Eastern Cooperative Oncology Group
North Central Cancer Treatment Group
Purpose
RATIONALE: Drugs used in chemotherapy, such as cisplatin and docetaxel, work in different
ways to stop the growth of tumor cells, either by killing the cells or by stopping them from
dividing. Radiation therapy uses high-energy x-rays to kill tumor cells. Cisplatin and
docetaxel may make tumor cells more sensitive to radiation therapy. Giving more than one
drug (combination chemotherapy) together with radiation therapy before surgery may shrink
the tumor so it can be removed. Giving chemotherapy after surgery may kill any tumor cells
that remain after surgery. It is not yet known whether giving cisplatin and docetaxel
together with radiation therapy is more effective than giving cisplatin together with
docetaxel in treating non-small cell lung cancer.
PURPOSE: This randomized phase III trial is studying cisplatin, docetaxel, and radiation
therapy to see how well they work compared to cisplatin and docetaxel in treating patients
who are undergoing surgery for newly diagnosed stage III non-small cell lung cancer.
Study Design: Treatment, Randomized, Active Control
Eligibility
Genders Eligible for Study: Both
Ages eligible for study: 18 Years to N/A
DISEASE CHARACTERISTICS:
- Histologically or cytologically confirmed primary non-small cell lung cancer
(NSCLC)*, including any of the following cellular types:
- Adenocarcinoma
- Squamous cell carcinoma
- Large cell carcinoma
- Non-lobar and non-diffuse bronchoalveolar cell carcinoma
- NSCLC not otherwise specified NOTE: *Diagnosed within the past 3 months;
diagnosis by mediastinal nodal biopsy or needle aspiration allowed provided a
distinct lung primary (separate from the nodes) is clearly evident on CT scan
- Stage IIIA disease
- T1-T3 disease
- If pleural effusion is present, must meet ≥ 1 of the following criteria to
exclude T4 disease:
- Pleural effusion cytologically negative by thoracentesis
- Documented absence of pleural metastases and pleural effusion
cytologically negative by thoracoscopy (for patients with pleural
effusion on CT scan [but not on chest x-ray] that is deemed too small
to tap safely under either CT scan or ultrasound guidance)
- Confirmed positive ipsilateral mediastinal lymph node(s) (N2 disease)**, with or
without positive ipsilateral hilar nodes, by mediastinoscopy, mediastinotomy,
endoscopic ultrasound-guided transesophageal biopsy, thoracotomy, video-assisted
thoracoscopy, Wang needles, or fine needle aspiration under bronchoscopic or CT
guidance
- N2 nodes must be separate from primary tumor by CT scan or surgical
exploration AND maximum diameter ≤ 3.0 cm
- Mediastinoscopy OR other means of mediastinal lymph node biopsy required
(regardless of the primary tumor site) for patients with subcarinal
lymphadenopathy by size criteria or by positron emission tomography (PET)
scan
- If the lymph nodes in the contralateral mediastinum and neck are visible by
contrast CT scan of the chest AND are ≥ 1.0 cm OR if contralateral
involvement is suggested by PET scan, lymph nodes must be confirmed
negative by one of the above diagnostic procedures AND N3 status must be
confirmed negative by histology or cytology
- No palpable lymph nodes in the supraclavicular areas or higher in the neck
unless proven benign by excisional biopsy
- A nodal biopsy or needle aspiration may be omitted provided all of the
following criteria are true:
- Paralyzed left true vocal cord by bronchoscopy or indirect
laryngoscopy
- Nodes visible in the aortopulmonary window (level 5) region on CT scan
- Distinct primary tumor (separate from the nodes) is visible by CT scan
- No evidence of subcarinal nodal involvement by CT scan NOTE: **PET
scan positivity is not sufficient to establish N2 nodal status
- Measurable disease by chest x-ray and/or contrast-enhanced CT scan
- Candidate for surgery
- Resectable disease
- No distant metastases, including other ipsilateral or contralateral parenchymal
lesions or liver or adrenal metastases, by history or physical examination,
fludeoxyglucose F 18 PET scan, MRI or CT scan of the brain, chest x-ray and/or CT
scan of the lungs and upper abdomen
PATIENT CHARACTERISTICS:
Age
- 18 and over
Performance status
- Zubrod 0-1
Life expectancy
- Not specified
Hematopoietic
- Absolute neutrophil count ≥ 1,800/mm^3
- Platelet count ≥ 100,000/mm^3
- Hemoglobin ≥ 10.0 g/dL (transfusion or other intervention allowed)
Hepatic
- ALT and AST ≤ 2.5 times upper limit of normal (ULN)
- Alkaline phosphatase ≤ 2.5 times ULN
- Bilirubin ≤ 1.5 times ULN
- No hepatic insufficiency resulting in clinical jaundice or coagulation defects
Renal
- Creatinine clearance ≥ 60 mL/min
Cardiovascular
- No unstable angina or congestive heart failure requiring hospitalization within the
past 6 months
- No transmural myocardial infarction within the past 6 months
Pulmonary
- FEV_1 ≥ 2.0 L OR
- Predicted post-resection FEV_1 ≥ 0.8 L
- DLCO ≥ 50% of predicted
- No chronic obstructive pulmonary disease exacerbation
- No other respiratory illness requiring hospitalization or that would preclude study
therapy
Immunologic
- No AIDS
- No prior allergic reaction to the study drugs
- No history of severe hypersensitivity to other drugs formulated with polysorbate 80
- No acute bacterial or fungal infection requiring IV antibiotics
Other
- Not pregnant or nursing
- Negative pregnancy test
- Fertile patients must use effective contraception
- No unintentional weight loss > 5% of body weight within the past 6 months
- No pre-existing peripheral neuropathy ≥ grade 2
- No other invasive malignancy within the past 3 years except nonmelanoma skin cancer
or carcinoma in situ of the breast, oral cavity, or cervix
- No other severe active comorbidity
PRIOR CONCURRENT THERAPY:
Biologic therapy
- No prior biological agent for this cancer
- No concurrent filgrastim (G-CSF), sargramostim (GM-CSF), or pegfilgrastim during
study induction therapy (for patients randomized to the chemoradiotherapy arm)
Chemotherapy
- No prior systemic chemotherapy for this cancer
- Prior chemotherapy for a different cancer allowed
Endocrine therapy
- Not specified
Radiotherapy
- No prior radiotherapy to the region of this cancer that would result in overlap of
radiotherapy fields
- No routine post-operative radiotherapy
- No concurrent intensity modulated radiotherapy
Surgery
- See Disease Characteristics
Other
- No prior gefitinib for this cancer
- No concurrent amifostine
More Information
Study ID numbers:
CDR0000429479
RTOG-0412
SWOG-S0332
CALGB-RTOG-0412
ECOG-RTOG-0412
NCCTG-RTOG-0412
ClinicalTrials Identifier - NCT00113386
For additional information, visit ClinicalTrials.gov.
Information obtained from ClinicalTrials.gov on 11/23/2009
This directory includes clinical trials that involve researchers at UCSD Medical
Center. The information was obtained from ClinicalTrials.gov, a database of the
U.S. National Institutes of Health.
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