Lung Cancer Clinical Trial

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

Summary

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.

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Full Description

OBJECTIVES:

Primary

Compare overall survival of patients with newly diagnosed favorable prognosis stage IIIA non-small cell lung cancer treated with neoadjuvant cisplatin and docetaxel with vs without thoracic conformal radiotherapy followed by surgical resection and docetaxel.

Secondary

Compare median and progression-free survival of patients treated with these regimens.
Compare clinical and pathologic response rates in patients treated with these regimens.
Compare the toxicity of these regimens in these patients.
Correlate pathological complete response with disease-free and overall survival of patients treated with these regimens.
Correlate DNA damage repair genes (ERCC1 and XRCC1), microtubule-related proteins (TUBB-III and MAP4), and shed tumor DNA with response and outcome in patients treated with these regimens.
Correlate protein profiles, using MALDI-TOF proteomic analysis of tumor and serum, with response and prognosis in patients treated with these regimens.
Compare quality of life of patients treated with these regimens.
Determine the efficacy of fludeoxyglucose F 18 positron emission tomography scanning in assessing pathological response of the tumor and the mediastinal lymph nodes and in predicting long-term outcome in patients treated with these regimens.
Correlate comorbid conditions with survival of patients treated with these regimens.

OUTLINE: This is a randomized, multicenter study. Patients are stratified according to T stage (T1 vs T2-3), number of involved mediastinal lymph nodes (1 vs 2 or more vs not evaluable), and nodal micrometastases vs clinically involved nodes (mN2 vs cN2).

Induction therapy: Patients are randomized to 1 of 2 treatment arms.

Arm I: Patients receive cisplatin IV over 1 hour and docetaxel IV over 1 hour on days 1 and 22.
Arm II: Patients undergo thoracic conformal radiotherapy once daily 5 days a week for approximately 5½ weeks (total of 28 doses). Patients also receive cisplatin IV over 1 hour on days 1, 8, 22, and 29 and docetaxel IV over 1 hour on days 1, 8, 15, 22, and 29.
Surgery: Within 4-8 weeks after completion of induction therapy, patients with stable disease or better undergo a lobectomy or pneumonectomy with a formal systematic mediastinal lymph node dissection.
Consolidation therapy: Beginning 4-6 weeks after surgery, patients receive docetaxel IV over 1 hour on days 1, 22, and 43 and pegfilgrastim or filgrastim (G-CSF) subcutaneously on days 2, 23, and 44.

Quality of life is assessed at baseline, within 2 weeks after completion of induction therapy, and then at 6 and 12 months after surgery.

After completion of study treatment, patients are followed every 3 months for 1 year, every 6 months for 2 years, and then annually thereafter.

PROJECTED ACCRUAL: A total of 574 patients will be accrued for this study within 4 years.

View Eligibility Criteria

Eligibility Criteria

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

Study is for people with:

Lung Cancer

Phase:

Phase 3

Estimated Enrollment:

19

Study ID:

NCT00113386

Recruitment Status:

Terminated

Sponsor:

Radiation Therapy Oncology Group

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There are 75 Locations for this study

See Locations Near You

Cancer Center at Providence Alaska Medical Center
Anchorage Alaska, 99519, United States
Arkansas Cancer Research Center at University of Arkansas for Medical Sciences
Little Rock Arkansas, 72205, United States
Cancer Care Center at John Muir Health - Concord Campus
Concord California, 94524, United States
Moores UCSD Cancer Center
La Jolla California, 92093, United States
USC/Norris Comprehensive Cancer Center and Hospital
Los Angeles California, 90089, United States
University of California Davis Cancer Center
Sacramento California, 95817, United States
Memorial Hospital
Colorado Springs Colorado, 80909, United States
Front Range Cancer Specialists
Fort Collins Colorado, 80524, United States
Poudre Valley Hospital
Fort Collins Colorado, 80524, United States
CCOP - Christiana Care Health Services
Newark Delaware, 19713, United States
Mayo Clinic - Jacksonville
Jacksonville Florida, 32224, United States
Ella Milbank Foshay Cancer Center at Jupiter Medical Center
Jupiter Florida, 33458, United States
Watson Clinic, LLC
Lakeland Florida, 33804, United States
CCOP - Mount Sinai Medical Center
Miami Beach Florida, 33140, United States
Phoebe Cancer Center at Phoebe Putney Memorial Hospital
Albany Georgia, 31701, United States
CCOP - Atlanta Regional
Atlanta Georgia, 30342, United States
Northeast Georgia Medical Center
Gainesville Georgia, 30501, United States
Delnor Community Hospital - Geneva
Geneva Illinois, 60134, United States
Cardinal Bernardin Cancer Center at Loyola University Medical Center
Maywood Illinois, 60153, United States
Community Cancer Center
Normal Illinois, 61761, United States
Advocate Christ Medical Center
Oak Lawn Illinois, 60453, United States
Cancer Treatment Center at Pekin Hospital
Pekin Illinois, 61554, United States
Oncology Hematology Associates of Central Illinois, PC - Peoria
Peoria Illinois, 61615, United States
OSF St. Francis Medical Center
Peoria Illinois, 61637, United States
Cancer Institute at St. John's Hospital
Springfield Illinois, 62702, United States
Reid Hospital & Health Care Services, Incorporated
Richmond Indiana, 47374, United States
Memorial Hospital of South Bend
South Bend Indiana, 46601, United States
Hematology Oncology Associates of the Quad Cities
Bettendorf Iowa, 52722, United States
Genesis Regional Cancer Center at Genesis Medical Center
Davenport Iowa, 52803, United States
Markey Cancer Center at University of Kentucky Chandler Medical Center
Lexington Kentucky, 40536, United States
St. Agnes Hospital Cancer Center
Baltimore Maryland, 21229, United States
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Baltimore Maryland, 21231, United States
Frederick Memorial Hospital Regional Cancer Therapy Center
Frederick Maryland, 21701, United States
Massachusetts General Hospital Cancer Center
Boston Massachusetts, 02114, United States
CCOP - Michigan Cancer Research Consortium
Ann Arbor Michigan, 48106, United States
University of Michigan Comprehensive Cancer Center
Ann Arbor Michigan, 48109, United States
Bronson Methodist Hospital
Kalamazoo Michigan, 49007, United States
Upper Michigan Cancer Center at Marquette General Hospital
Marquette Michigan, 49855, United States
Mayo Clinic Cancer Center
Rochester Minnesota, 55905, United States
St. John's Regional Medical Center
Joplin Missouri, 64804, United States
St. John's Regional Health Center
Springfield Missouri, 65804, United States
Siteman Cancer Center at Barnes-Jewish Hospital
St Louis Missouri, 63110, United States
Good Samaritan Cancer Center at Good Samaritan Hospital
Kearney Nebraska, 68848, United States
Methodist Cancer Center at Methodist Hospital - Omaha
Omaha Nebraska, 68114, United States
UNMC Eppley Cancer Center at the University of Nebraska Medical Center
Omaha Nebraska, 68198, United States
Valley Hospital - Ridgewood
Ridgewood New Jersey, 07450, United States
NYU Cancer Institute at New York University Medical Center
New York New York, 10016, United States
SUNY Upstate Medical University Hospital
Syracuse New York, 13210, United States
Faxton Regional Cancer Center
Utica New York, 13502, United States
Duke Comprehensive Cancer Center
Durham North Carolina, 27710, United States
Leo W. Jenkins Cancer Center at ECU Medical School
Greenville North Carolina, 27835, United States
Lenoir Memorial Cancer Center
Kinston North Carolina, 28501, United States
FirstHealth Moore Regional Community Hospital Comprehensive Cancer Center
Pinehurst North Carolina, 28374, United States
Charles M. Barrett Cancer Center at University Hospital
Cincinnati Ohio, 45267, United States
Arthur G. James Cancer Hospital and Solove Research Institute at Ohio State University
Columbus Ohio, 43210, United States
Veterans Affairs Medical Center - Portland
Portland Oregon, 97207, United States
Oregon Health & Science University Cancer Institute
Portland Oregon, 97239, United States
St. Luke's Hospital Cancer Center
Bethlehem Pennsylvania, 18015, United States
Penn State Cancer Institute at Milton S. Hershey Medical Center
Hershey Pennsylvania, 17033, United States
Lancaster General Hospital
Lancaster Pennsylvania, 17604, United States
Kimmel Cancer Center at Thomas Jefferson University - Philadelphia
Philadelphia Pennsylvania, 19107, United States
Albert Einstein Cancer Center
Philadelphia Pennsylvania, 19141, United States
Allegheny Cancer Center at Allegheny General Hospital
Pittsburgh Pennsylvania, 15212, United States
York Cancer Center at Apple Hill Medical Center
York Pennsylvania, 17405, United States
Hollings Cancer Center at Medical University of South Carolina
Charleston South Carolina, 29425, United States
CCOP - Greenville
Greenville South Carolina, 29615, United States
CCOP - Upstate Carolina
Spartanburg South Carolina, 29303, United States
U.T. Cancer Institute at University of Tennessee Medical Center
Knoxville Tennessee, 37920, United States
Medical City Dallas Hospital
Dallas Texas, 75230, United States
Simmons Comprehensive Cancer Center at University of Texas Southwestern Medical Center - Dallas
Dallas Texas, 75390, United States
CCOP - Virginia Mason Research Center
Seattle Washington, 98101, United States
Swedish Cancer Institute at Swedish Medical Center - First Hill Campus
Seattle Washington, 98122, United States
Madigan Army Medical Center - Tacoma
Tacoma Washington, 98431, United States
Vince Lombardi Cancer Clinic - Green Bay at Aurora BayCare Medical Center
Green Bay Wisconsin, 54311, United States
Dean Medical Center - Madison
Madison Wisconsin, 53717, United States
Vince Lombardi Cancer Clinic - Sheboygan
Sheboygan Wisconsin, 53081, United States

How clear is this clinincal trial information?

Study is for people with:

Lung Cancer

Phase:

Phase 3

Estimated Enrollment:

19

Study ID:

NCT00113386

Recruitment Status:

Terminated

Sponsor:


Radiation Therapy Oncology Group

How clear is this clinincal trial information?

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