Know Cancer

forgot password

A Randomized Phase III Trial of Carboplatin, Paclitaxel and Thoracic Radiotherapy, With or Without Thalidomide, in Patients With Stage III Non-Small Cell Lung Cancer (NSCLC)

Phase 3
18 Years
Not Enrolling
Lung Cancer

Thank you

Trial Information

A Randomized Phase III Trial of Carboplatin, Paclitaxel and Thoracic Radiotherapy, With or Without Thalidomide, in Patients With Stage III Non-Small Cell Lung Cancer (NSCLC)


I. Compare the survival and time to progression of patients with stage IIIA or IIIB
non-small cell lung cancer when treated with carboplatin, paclitaxel, and chemoradiotherapy
with or without thalidomide.

II. Evaluate the toxicity of the thalidomide-containing regimen and compare response rates
of the two groups.

III. Determine whether the inactivation of p16, Death-associated protein kinase
(DAP-kinase), O6-methylguanine-DNA methyltransferase (MGMT) gene, or tissue-inhibitor of
metalloproteinase 3 (TIMP-3) genes can be used to predict survival in these patients treated
with this regimen.

IV. Determine whether the detection of a methylation biomarker in serum can be used to
predict survival in these patients treated with this regimen.

OUTLINE: This is a randomized study. Patients are stratified according to disease histology
(squamous vs nonsquamous), performance status (0 vs 1), disease stage (IIIA vs IIIB), and
time of randomization (before addition of chemoradiotherapy vs after). Patients are
randomized to one of two treatment arms.

ARM A: Patients receive paclitaxel intravenously (IV) over 3 hours immediately followed by
carboplatin IV over 15-30 minutes on days 1 and 22. Treatment continues every 22 days in the
absence of unacceptable toxicity or disease progression.

ARM B: Patients receive paclitaxel and carboplatin as in arm A. Patients also receive oral
thalidomide and oral low-dose aspirin daily beginning on day 1 for up to 24 months in the
absence of disease progression.

Beginning between days 43-50, patients in both arms with stable or responding disease
receive chemoradiotherapy comprising paclitaxel IV over 1 hour and carboplatin IV over 15-30
minutes once weekly for 6 weeks and radiotherapy (RT) 5 days a week for 6 weeks. Arm B
patients continue oral thalidomide.

Patients are followed every 2 months for 2 years and then every 6 months for 3 years.

Inclusion Criteria:

- Histologically confirmed newly diagnosed non-small cell bronchogenic carcinoma

- Squamous cell

- Adenocarcinoma

- Large cell undifferentiated

- Bronchoalveolar

- Non-small cell carcinoma not otherwise stated

- Unresectable stage IIIA

- Mediastinal lymph node enlargement of at least 1 cm but less than 2 cm on
computed tomography (CT) scans must have mediastinotomy or thoracoscopy to rule
out resectability


- Stage IIIB disease without significant pleural effusion

- Seen on CT scan only (not seen on chest x-ray) or does not reaccumulate after 1
thoracentesis and is cytologically negative

- Metastases to contralateral, mediastinal, or supraclavicular nodes allowed

- Bidimensionally measurable or evaluable disease

- 18 and over

- ECOG performance status 0-1

- Adequate hematopoietic, hepatic, and renal function obtained <=4 weeks prior to

- Platelet count at least 100,000/mm^3

- White Blood Cell (WBC) count at least 4,000/mm^3 OR absolute neutrophil count at
least 2,000/mm^3

- Bilirubin normal

- Serum glutamic oxaloacetic transaminase (SGOT) no greater than 2.5 times upper
limit of normal

- Creatinine no greater than 1.5 mg/dL OR creatinine clearance at least 60 mL/min

- Fertile patients must use 2 methods of effective contraception for 4 weeks prior to,
during, and for 4 weeks after study therapy

- Concurrent filgrastim (G-CSF) allowed for persistent neutropenia

Exclusion Criteria:

- Positive pregnancy test,pregnant or nursing

- Uncontrolled high blood pressure, unstable angina, congestive heart failure, or
myocardial infarction within the prior year

- Serious cardiac arrhythmias requiring medication

- Prior radiotherapy to only area of measurable or active tumor

- Less than 5 years since prior chemotherapy

- Other active malignancies

- Serious uncontrolled active infection

- Evidence of greater than grade 1 neuropathy by history or physical examination

- History of seizure disorders

- Contraindication to daily low-dose (81 mg/day) aspirin

Type of Study:


Study Design:

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Overall Survival Time

Outcome Description:

Survival time is defined as time from study entry to death from any cause

Outcome Time Frame:

every other month until 24 months from study entry, then every 3 months for year 3, every 4 months for year 4 and every 6 months for year 5

Safety Issue:


Principal Investigator

Joan H. Schiller, MD

Investigator Role:

Study Chair

Investigator Affiliation:

Simmons Cancer Center


United States: Food and Drug Administration

Study ID:




Start Date:

January 2000

Completion Date:

May 2011

Related Keywords:

  • Lung Cancer
  • squamous cell lung cancer
  • large cell lung cancer
  • stage IIIA non-small cell lung cancer
  • stage IIIB non-small cell lung cancer
  • adenocarcinoma of the lung
  • adenosquamous cell lung cancer
  • bronchoalveolar cell lung cancer
  • Carcinoma, Non-Small-Cell Lung
  • Lung Neoplasms



Akron City Hospital Akron, Ohio  44304
Hurley Medical Center Flint, Michigan  48503
CCOP - Kansas City Kansas City, Missouri  64131
CCOP - Missouri Valley Cancer Consortium Omaha, Nebraska  68131
Veterans Affairs Medical Center - Atlanta (Decatur) Decatur, Georgia  30033
CCOP - Iowa Oncology Research Association Des Moines, Iowa  50309-1016
CCOP - Metro-Minnesota Saint Louis Park, Minnesota  55416
Veterans Affairs Medical Center - East Orange East Orange, New Jersey  07018-1095
Aurora Presbyterian Hospital Aurora, Colorado  80012
Boulder Community Hospital Boulder, Colorado  80301-9019
Penrose Cancer Center at Penrose Hospital Colorado Springs, Colorado  80933
Porter Adventist Hospital Denver, Colorado  80210
Presbyterian - St. Luke's Medical Center Denver, Colorado  80218
St. Joseph Hospital Denver, Colorado  80218
Rose Medical Center Denver, Colorado  80220
Swedish Medical Center Englewood, Colorado  80110
St. Mary's Regional Cancer Center at St. Mary's Hospital and Medical Center Grand Junction, Colorado  81502
Sky Ridge Medical Center Lone Tree, Colorado  80124
Hope Cancer Care Center at Longmont United Hospital Longmont, Colorado  80502
North Suburban Medical Center Thornton, Colorado  80229
Hinsdale Hematology Oncology Associates Hinsdale, Illinois  60521
Cedar Rapids Oncology Associates Cedar Rapids, Iowa  52403
Mercy Medical Center - Sioux City Sioux City, Iowa  51104
Siouxland Hematology-Oncology Associates, LLP Sioux City, Iowa  51101
St. Luke's Regional Medical Center Sioux City, Iowa  51104
Tufts-NEMC Cancer Center Boston, Massachusetts  02111
Baystate Regional Cancer Program at D'Amour Center for Cancer Care Springfield, Massachusetts  01199
CCOP - Michigan Cancer Research Consortium Ann Arbor, Michigan  48106
Oakwood Cancer Center at Oakwood Hospital and Medical Center Dearborn, Michigan  48123-2500
Genesys Hurley Cancer Institute Flint, Michigan  48503
Van Elslander Cancer Center at St. John Hospital and Medical Center Grosse Pointe Woods, Michigan  48236
Foote Hospital Jackson, Michigan  49201
Bronson Methodist Hospital Kalamazoo, Michigan  49007
West Michigan Cancer Center Kalamazoo, Michigan  49007-3731
Borgess Medical Center Kalamazooaa, Michigan  49001
Sparrow Regional Cancer Center Lansing, Michigan  48912-1811
Seton Cancer Institute - Saginaw Saginaw, Michigan  48601
St. John Macomb Hospital Warren, Michigan  48093
Fairview Ridges Hospital Burnsville, Minnesota  55337
Mercy and Unity Cancer Center at Mercy Hospital Coon Rapids, Minnesota  55433
CCOP - Duluth Duluth, Minnesota  55805
Fairview Southdale Hospital Edina, Minnesota  55435
Mercy and Unity Cancer Center at Unity Hospital Fridley, Minnesota  55432
Hutchinson Area Health Care Hutchinson, Minnesota  55350
Meeker County Memorial Hospital Lichfield, Minnesota  55355
HealthEast Cancer Care at St. John's Hospital Maplewood, Minnesota  55109
Hennepin County Medical Center - Minneapolis Minneapolis, Minnesota  55415
Regions Hospital Cancer Care Center St. Paul, Minnesota  55101
United Hospital St. Paul, Minnesota  55102
Ridgeview Medical Center Waconia, Minnesota  55387
St. Rita's Medical Center Lima, Ohio  45801
Geisinger Medical Center Danville, Pennsylvania  17822-0001
Penn State Cancer Institute at Milton S. Hershey Medical Center Hershey, Pennsylvania  17033-0850
Frank M. and Dorothea Henry Cancer Center at Geisinger Wyoming Valley Medical Center Wilkes-Barre, Pennsylvania  18711
Medical X-Ray Center, PC Sioux Falls, South Dakota  57105
Avera Cancer Institute Sioux Falls, South Dakota  57105
Gundersen Lutheran Cancer Center at Gundersen Lutheran Medical Center La Crosse, Wisconsin  54601
Dean Medical Center - Madison Madison, Wisconsin  53717
Marshfield Clinic - Marshfield Center Marshfield, Wisconsin  54449
Memorial Hospital of South Bend South Bend, Indiana  46601
CCOP - Montana Cancer Consortium Billings, Montana  59101
CCOP - Columbus Columbus, Ohio  43206
Veterans Affairs Medical Center - Dayton Dayton, Ohio  45428
Reading Hospital and Medical Center Reading, Pennsylvania  19612-6052
Mercy Hospital Cancer Center - Scranton Scranton, Pennsylvania  18501
Grand View Hospital Sellersville, Pennsylvania  18960
CCOP - MainLine Health Wynnewood, Pennsylvania  19096
CCOP - Greenville Greenville, South Carolina  29615
University of Wisconsin Comprehensive Cancer Center Madison, Wisconsin  53792
CCOP - Northern Indiana CR Consortium South Bend, Indiana  46601
Saint Joseph Regional Medical Center South Bend, Indiana  46617
MetroHealth's Cancer Care Center at MetroHealth Medical Center Cleveland, Ohio  44106
CCOP - Scott and White Hospital Temple, Texas  76508
Veterans Affairs Medical Center - Buffalo Buffalo, New York  14215
John Stoddard Cancer Center at Iowa Methodist Medical Center Des Moines, Iowa  50309
Medical Center of Central Georgia Macon, Georgia  31201
St. Vincent Mercy Medical Center Toledo, Ohio  43608
CCOP - Colorado Cancer Research Program, Incorporated Denver, Colorado  80224
Hillman Cancer Center at University of Pittsburgh Cancer Institute Pittsburgh, Pennsylvania  15236
Great Falls Clinic Great Falls, Montana  59405
Overlook Hospital Summit, New Jersey  07902-0220
Hulston Cancer Center at Cox Medical Center South Springfield, Missouri  65807
St. John's Regional Health Center Springfield, Missouri  65804
Carol G. Simon Cancer Center at Morristown Memorial Hospital Morristown, New Jersey  07962
Sioux Valley Hospital and University of South Dakota Medical Center Sioux Falls, South Dakota  57117-5134
Cancer Institute of New Jersey at Hamilton Hamilton, New Jersey  08690
CCOP - Toledo Community Hospital Toledo, Ohio  43623-3456
Curtis & Elizabeth Anderson Cancer Institute at Memorial Health University Medical Center Savannah, Georgia  31403-3089
Albert Einstein Cancer Center at Albert Einstein College of Medicine Bronx, New York  10461
Medical University of Ohio Cancer Center Toledo, Ohio  43614
Toledo Hospital Toledo, Ohio  43606
West Virginia University - Robert C. Byrd Health Sciences Center - Charleston Division Charleston, West Virginia  25302
St. Vincent Hospital Regional Cancer Center Green Bay, Wisconsin  54307-3508
Aultman Hospital Cancer Center at Aultman Health Foundation Canton, Ohio  44710-1799
St. Mary's - Duluth Clinic Cancer Center Duluth, Minnesota  55805
Green Bay Oncology, Limited - Escanaba Escanaba, Michigan  49431
Hunterdon Regional Cancer Center at Hunterdon Medical Center Flemington, New Jersey  08822
Warren Hospital Phillipsburg, New Jersey  08865
Our Lady of Mercy Medical Center Comprehensive Cancer Center Bronx, New York  10466
CCOP - Hematology-Oncology Associates of Central New York East Syracuse, New York  13057
Lewistown Hospital Lewistown, Pennsylvania  17044
Mount Nittany Medical Center State College, Pennsylvania  16803
St. Mary's Hospital Medical Center - Green Bay Green Bay, Wisconsin  54303
Green Bay Oncology, Limited at St. Mary's Hospital Green Bay, Wisconsin  54303
Bay Area Cancer Care Center at Bay Area Medical Center Marinette, Wisconsin  54143
Green Bay Oncology, Limited - Oconto Falls Oconto Falls, Wisconsin  54154
Green Bay Oncology, Limited - Sturgeon Bay Sturgeon Bay, Wisconsin  54235
Hematology Oncology Associates of the Quad Cities Bettendorf, Iowa  52722
Baptist Cancer Institute - Jacksonville Jacksonville, Florida  32207
Northern Rockies Radiation Oncology Center Billings, Montana  59101
Deaconess Billings Clinic - Downtown Billings, Montana  59101
Big Sky Oncology Great Falls, Montana  59405
Wayne Memorial Hospital, Incorporated Goldsboro, North Carolina  27534
Adena Regional Medical Center Chillicothe, Ohio  54601
Doctors Hospital at Ohio Health Columbus, Ohio  43228
Riverside Methodist Hospital Cancer Care Columbus, Ohio  43214
Grant Riverside Cancer Services Columbus, Ohio  43215
Grady Memorial Hospital Delaware, Ohio  43015
Fairfield Medical Center Lancaster, Ohio  43130
Strecker Cancer Center at Marietta Memorial Hospital Marietta, Ohio  45750
Licking Memorial Cancer Care Program at Licking Memorial Hospital Newark, Ohio  43055
Community Hospital of Springfield and Clark County Springfield, Ohio  45505
Lakeland Cancer Care Center at Lakeland Hospital - St. Joseph Saint Joseph, Michigan  49085
MBCCOP - Medical College of Georgia Cancer Center Augusta, Georgia  30912-3730
Swedish-American Regional Cancer Center Rockford, Illinois  61104-2315
CCOP - Nevada Cancer Research Foundation Las Vegas, Nevada  89109-2306
Cancer Institute of New Jersey at UMDNJ - Robert Wood Johnson Medical School New Brunswick, New Jersey  08903
Virginia Commonwealth University Massey Cancer Center Richmond, Virginia  23298-0037
Robert H. Lurie Comprehensive Cancer Center at Northwestern University Chicago, Illinois  60611
Paoli Memorial Hospital Paoli, Pennsylvania  19301-1792
Elkhart General Hospital Elkhart, Indiana  46515
Fox Chase Virtua Health Cancer Program at Virtua Memorial Hospital Marlton Marlton, New Jersey  08053
Fox Chase Virtua Health Cancer Program at Virtua West Jersey Voorhees, New Jersey  08043
Mount Carmel Health - West Hospital Columbus, Ohio  43222
Morgan Cancer Center at Lehigh Valley Hospital - Cedar Crest Allentown, Pennsylvania  18105
Joan Karnell Cancer Center at Pennsylvania Hospital Philadelphia, Pennsylvania  19107
Jennersville Regional Hospital West Grove, Pennsylvania  19390-9499
Memorial Medical Center Cancer Services Modesto, California  95355
Salinas Valley Memorial Hospital Salinas, California  93901
Memorial Hospital Colorado Springs, Colorado  80909
St. Mary-Corwin Regional Medical Center Pueblo, Colorado  81004
Swedish Covenant Hospital Chicago, Illinois  60625
Mercy Hospital and Medical Center Chicago, Illinois  60616
Midwest Center for Hematology/Oncology Joliet, Illinois  60432
Trinity Medical Center - East Moline, Illinois  61265
Hematology/Oncology of the North Shore at Gross Point Medical Center Skokie, Illinois  60076
Howard Community Hospital at Howard Regional Health System Kokomo, Indiana  46904
Center for Cancer Therapy at LaPorte Hospital and Health Services La Porte, Indiana  46350
Reid Hospital & Health Care Services, Incorporated Richmond, Indiana  47374
St. Luke's Hospital Cedar Rapids, Iowa  52402
Mercy Regional Cancer Center at Mercy Medical Center Cedar Rapids, Iowa  52403
Genesis Regional Cancer Center at Genesis Medical Center Davenport, Iowa  52803
John Stoddard Cancer Center at Iowa Lutheran Hospital Des Moines, Iowa  50316-2301
Mercy Capitol Hospital Des Moines, Iowa  50307
Medical Oncology and Hematology Associates at John Stoddard Cancer Center Des Moines, Iowa  50309
Medical Oncology and Hematology Associates at Mercy Cancer Center Des Moines, Iowa  50314
Mercy Cancer Center at Mercy Medical Center - Des Moines Des Moines, Iowa  50314
Medical Oncology and Hematology Associates - West Des Moines West Des Moines, Iowa  50266
Hickman Cancer Center at Bixby Medical Center Adrian, Michigan  49221
St. Joseph Mercy Cancer Center at St. Joseph Mercy Hospital Ann Arbor, Michigan  48106-0995
Green Bay Oncology, Limited - Iron Mountain Iron Mountain, Michigan  49801
Mercy Memorial Hospital System Monroe, Michigan  48162
Alexandria, Minnesota  56308
Virginia Piper Cancer Institute at Abbott-Northwestern Hospital Minneapolis, Minnesota  55407
Hubert H. Humphrey Cancer Center at North Memorial Medical Center Robbinsdale, Minnesota  55422-2900
CentraCare Clinic - River Campus St. Cloud, Minnesota  56303
Park Nicollet Health Services St. Louis Park, Minnesota  55416
Immanuel Medical Center Omaha, Nebraska  68122
Creighton University Medical Center Omaha, Nebraska  68131-2197
Mountainside Hospital Cancer Center Montclair, New Jersey  07042
Booker Cancer Center at Riverview Medical Center Red Bank, New Jersey  07701
Wilson Medical Center Wilson, North Carolina  27893-3428
Cancer Care Center at Medcenter One Hospital Bismarck, North Dakota  58501
Bismarck Cancer Center Bismarck, North Dakota  58501
St. Alexius Medical Center Bismarck, North Dakota  58502
Mid Dakota Clinic, P. C. Bismarck, North Dakota  58501
Samaritan North Cancer Care Center Dayton, Ohio  45415
David L. Rike Cancer Center at Miami Valley Hospital Dayton, Ohio  45409
Blanchard Valley Medical Associates Findlay, Ohio  45840
Fremont Memorial Hospital Fremont, Ohio  43420
Charles F. Kettering Memorial Hospital Kettering, Ohio  45429
Lima Memorial Hospital Lima, Ohio  45804
St. Luke's Hospital Maumee, Ohio  43537
Northwest Ohio Oncology Center Maumee, Ohio  43537
St. Charles Mercy Hospital Oregon, Ohio  43616
Firelands Regional Medical Center Sandusky, Ohio  44870
Mercy Medical Center Springfield, Ohio  45504
Mercy Hospital of Tiffin Tiffin, Ohio  44883
Toledo Clinic, Incorporated - Main Clinic Toledo, Ohio  43623
UVMC Cancer Care Center at Upper Valley Medical Center Troy, Ohio  45373-1300
Fulton County Health Center Wauseon, Ohio  43567
Bryn Mawr Hospital Bryn Mawr, Pennsylvania  19010
Hematology and Oncology Associates Scranton, Pennsylvania  18510
Lankenau Cancer Center at Lankenau Hospital Wynnewood, Pennsylvania  19096
Christine LaGuardia Phillips Cancer Center at Wellmont Holston Valley Medical Center Kingsport, Tennessee  37662
Danville Regional Medical Center Danville, Virginia  24541
Southwest Virginia Regional Cancer Center Norton, Virginia  24273
Green Bay Oncology, Limited at St. Vincent Hospital Green Bay, Wisconsin  54301-3526
DeCesaris Cancer Institute at Anne Arundel Medical Center Annapolis, Maryland  21401
William W. Backus Hospital Norwich, Connecticut  06360
Morton Hospital & Medical Center Taunton, Massachusetts  02780
Miller-Dwan Medical Center Duluth, Minnesota  55805
Lancaster General Hospital Lancaster, Pennsylvania  17604-3555
Pottstown Memorial Regional Cancer Center Pottstown, Pennsylvania  19464
Hembree Mercy Cancer Center at St. Edward Mercy Medical Center Ft. Smith, Arkansas  72903
Pearlman Comprehensive Cancer Center at South Georgia Medical Center Valdosta, Georgia  31603
Merle M. Mahr Cancer Center at Regional Medical Center of Hopkins County Madisonville, Kentucky  42431
Saint Francis Cancer Center Shakopee, Minnesota  55379
St. Joseph's Hospital St Paul, Minnesota  55102
Missouri Baptist Cancer Center St. Louis, Missouri  63131
Cancer Resource Center - Lincoln Lincoln, Nebraska  68510
Allegheny Cancer Center at Allegheny General Hospital Pittsburgh, Pennsylvania  15212
All Saints Cancer Center at All Saints Healthcare Racine, Wisconsin  53405
Praxair Cancer Center at Danbury Hospital Danbury, Connecticut  06810
Haematology-Oncology Associates of Ohio and Michigan, PC Lambertville, Michigan  48144
Alegant Health Cancer Center at Bergan Mercy Medical Center Omaha, Nebraska  68124
Flower Hospital Cancer Center Sylvania, Ohio  43560
Stanford Comprehensive Cancer Center at Stanford University Medical Center Stanford, California  94305
Easton Regional Cancer Center at Easton Hospital Easton, Pennsylvania  18042
MedCentral - Mansfield Hospital Mansfield, Ohio  44903
MBCCOP - Meharry Medical College - Nashville Nashville, Tennessee  37208-3599
University of Virginia Cancer Center at UV Health System Charlottesville, Virginia  22908
Great Falls, Montana  59405
Sletten Regional Cancer Institute at Benefis Healthcare Great Falls, Montana  59405
PinnacleHealth Regional Cancer Center at Polyclinic Hospital Harrisburg, Pennsylvania  17105
Cancer Care Institute of Carolina at Aiken Regional Medical Centers Aiken, South Carolina  29801
Lipson Cancer and Blood Center at Rochester General Hospital Rochester, New York  14621
Halifax Medical Center - Daytona Beach Daytona Beach, Florida  32115
Veterans Affairs Medical Center - Augusta Augusta, Georgia  30904
Newton-Wellesley Hospital Newton, Massachusetts  02462
Woodwinds Health Campus Woodbury, Minnesota  55125
Shore Memorial Hospital - Somers Point Somers Point, New Jersey  08244
Oncology Hematology Associates of Northern Pennsylvania, PC at Hahne Regional Cancer Center Dubois, Pennsylvania  15801
Cancer Center at Phoenixville Hospital Phoenixville, Pennsylvania  19460
Marshall University Medical Center Huntington, West Virginia  25701