Combination Chemotherapy With or Without Radiation Therapy in Treating Patients With Stage IIIA Non-small Cell Lung Cancer



Status:Completed
Conditions:Lung Cancer, Lung Cancer, Cancer
Therapuetic Areas:Oncology
Healthy:No
Age Range:18 - Any
Updated:7/14/2016
Start Date:May 1998
End Date:August 2005

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A Phase III Study of Surgical Resection and Chemotherapy (Paclitaxel and Carboplatin) With or Without Adjuvant Radiotherapy for Resected Stage IIIA Non-Small Cell Lung Cancer

RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing
so they stop growing or die. Combining more than one drug may kill more tumor cells.
Radiation therapy uses high-energy x-rays to damage tumor cells. It is not yet known if
combination chemotherapy is more effective with or without radiation therapy for stage IIIA
non-small cell lung cancer.

PURPOSE: Randomized phase III trial to compare the effectiveness of combination chemotherapy
with or without radiation therapy in treating patients who have stage IIIA non-small cell
lung cancer that has been surgically removed.

OBJECTIVES: I. Compare the overall survival of surgically resected patients with limited
stage IIIA non-small cell lung cancer who are treated by postoperative chemotherapy with or
without adjuvant radiotherapy. II. Compare failure free survival of these patients. III.
Describe the patterns of local and distant recurrence in these patients. IV. Determine the
toxicities associated with chemotherapy with or without adjuvant radiotherapy in these
patients.

OUTLINE: This is a randomized, multicenter study. Four to eight weeks after surgery, all
patients receive paclitaxel IV over 3 hours followed by carboplatin IV over 1-2 hours on
days 1, 22, 43, and 64. Following completion of four courses of chemotherapy, patients are
randomized into one of two treatment arms.

DISEASE CHARACTERISTICS: Histologically confirmed stage IIIA non-small cell lung cancer
that has been completely resected by lobectomy, bilobectomy, pneumonectomy, or sleeve
lobectomy through any incision (thoracoscopic or video assisted resection is acceptable)
No known residual disease present Involvement in N2 nodes must have been determined only
at the time of surgical exploration or by postoperative pathologic diagnosis All grossly
involved nodes must be removed at surgery No positive mediastinoscopy (if lymph nodes on
CT scan are greater than 1.5 cm in diameter, mediastinoscopy is required)

PATIENT CHARACTERISTICS: Age: 18 and over Performance status: ZUBROD 0-1 Life expectancy:
Not specified Hematopoietic: Granulocyte count at least 1,500/mm3 Platelet count at least
100,000/mm3 Hepatic: Bilirubin less than 1.5 mg/dL SGOT no greater than upper limit of
normal Renal: Creatinine clearance at least 20 mL/min Other: Not pregnant or nursing

PRIOR CONCURRENT THERAPY: Biologic therapy: No concurrent growth factors Chemotherapy: No
prior chemotherapy for non-small cell lung cancer No other concurrent chemotherapy
Endocrine therapy: No concurrent hormone therapy except: Steroids for adrenal failure
Hormones for nondisease related conditions Dexamethasone as an antiemetic Radiation
therapy: No prior radiotherapy for non-small cell lung cancer Surgery: See Disease
Characteristics
We found this trial at
16
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Toledo, OH
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Bismarck, North Dakota 58501
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Bismarck, ND
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Cedar Rapids, Iowa 52403
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Cedar Rapids, IA
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300 East Locust St., Ste 350
Des Moines, Iowa 50309
(515) 244-7586
CCOP - Iowa Oncology Research Association The Iowa Oncology Research Association (IORA) was established by...
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mi
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Des Moines, IA
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400 E Third Street
Duluth, Minnesota 55805
(218) 786-3868
CCOP - Duluth The Duluth CCOP, established and funded by the National Cancer Institute (NCI)...
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Duluth, MN
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Fargo, North Dakota 58122
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Fargo, ND
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Grand Forks, North Dakota 58201
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Grand Forks, ND
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Omaha, NE
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Peoria, IL
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353 Fairmont Blvd
Rapid City, South Dakota 57701
(605) 719-1000
Rapid City Regional Hospital Regional Health is an integrated health care system of more than...
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Rapid City, SD
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200 First Street SW
Rochester, Minnesota 55905
507-284-2511
Mayo Clinic Cancer Center The Mayo Clinic Cancer Center is a National Cancer Institute-designated comprehensive...
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mi
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Rochester, MN
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Scottsdale, Arizona 85259
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Scottsdale, AZ
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Sioux City, Iowa 51101
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Sioux City, IA
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Sioux Falls, South Dakota 57104
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Sioux Falls, SD
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509 W. University Avenue
Urbana, Illinois 61801
(217) 383-3516
CCOP - Carle Cancer Center The Carle Cancer Center Community Clinical Oncology Program (CCOP) in...
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Urbana, IL
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Wichita, Kansas 67214
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mi
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Wichita, KS
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