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Concurrent Carboplatin, Paclitaxel, and Radiation Therapy Versus Induction Carboplatin and Paclitaxel Followed by Concurrent Carboplatin, Paclitaxel and Radiation Therapy for Patients With Unresectable Stage III Non-Small Cell Lung Cancer: A Phase III Trial


Phase 3
18 Years
N/A
Not Enrolling
Both
Lung Cancer

Thank you

Trial Information

Concurrent Carboplatin, Paclitaxel, and Radiation Therapy Versus Induction Carboplatin and Paclitaxel Followed by Concurrent Carboplatin, Paclitaxel and Radiation Therapy for Patients With Unresectable Stage III Non-Small Cell Lung Cancer: A Phase III Trial


OBJECTIVES: I. Compare the effects of concurrent chemoradiotherapy utilizing carboplatin and
paclitaxel with or without prior induction chemotherapy on overall response rate,
disease-free survival, and overall survival in patients with unresectable stage III
non-small cell lung cancer. II. Compare the effects of these treatments on locoregional vs
distant failure in these patients. III. Compare the toxicity of these treatments in these
patients.

OUTLINE: This is a randomized study. Patients are stratified by measurable vs evaluable
disease. Patients are randomized to 1 of 2 treatment arms: Arm I (immediate concurrent
chemoradiotherapy): Patients receive IV paclitaxel over 1 hour followed by IV carboplatin
over 30 minutes on day 1, and radiation therapy to the chest 5 times a week beginning on day
1. Treatment repeats weekly for a total of 7 courses. Arm II (induction chemotherapy
followed by delayed concurrent chemoradiotherapy): Patients receive IV paclitaxel over 3
hours followed by IV carboplatin over 30 minutes; treatment repeats every 3 weeks for 2
courses. Patients then receive 7 courses of concurrent chemoradiotherapy as in Arm I. Total
treatment time is 13 weeks. Patients are followed every 2 months for 2 years, then every 4
months for the next 2 years, then annually thereafter.

PROJECTED ACCRUAL: A total of 360 patients will be accrued for this study within 3 years.

Inclusion Criteria


DISEASE CHARACTERISTICS: Histologically or cytologically confirmed non-small cell lung
cancer, including: Squamous cell carcinoma Adenocarcinoma (including bronchoalveolar cell)
Large cell anaplastic carcinoma (including giant and clear cell carcinomas) Inoperable or
unresectable stage IIIA or IIIB disease of the following stage groupings: T1 N2 M0 or T2
N2 M0 T3 N2 M0 and T4 N0-2 M0 eligible if staging is based on closeness to the carina or
invasion of the mediastinum or chest wall Patients with contralateral mediastinal disease
(N3) or tumors adjacent to but not invading a vertebral body are eligible if all gross
disease can be encompassed in the study radiation boost field Patients with a transudate,
cytologically negative, nonbloody pleural effusion are eligible if the tumor can be
encompassed within a reasonable field of radiotherapy Measurable or evaluable disease

PATIENT CHARACTERISTICS: Age: 18 and over Performance status: CALBG 0-1 Life expectancy:
Not specified Hematopoietic: Platelet count at least 100,000/mm3 Absolute granulocyte
count at least 1,500/mm3 Hepatic: Bilirubin less than 1.5 mg/dL AST less than 2 times
upper limit of normal Renal: Creatinine clearance at least 20 mL/min Other: Not pregnant
or nursing Effective contraception required of fertile patients No active second
malignancy except nonmelanomatous skin cancer

PRIOR CONCURRENT THERAPY: Biologic therapy: Not specified Chemotherapy: No prior
chemotherapy No other concurrent chemotherapy Endocrine therapy: No concurrent hormones
except for steroids administered for adrenal failure or septic shock, or hormones
administered for non-disease-related conditions (e.g., insulin for diabetes)
Glucocorticosteroids permitted as antiemetics Radiotherapy: No prior radiotherapy Surgery:
At least 2 weeks since exploratory thoracotomy

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Primary Purpose: Treatment

Principal Investigator

Everett E. Vokes, MD

Investigator Role:

Study Chair

Investigator Affiliation:

University of Chicago

Authority:

United States: Federal Government

Study ID:

CDR0000066383

NCT ID:

NCT00003387

Start Date:

July 1998

Completion Date:

April 2009

Related Keywords:

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

Name

Location

Roswell Park Cancer InstituteBuffalo, New York  14263
Memorial Sloan-Kettering Cancer CenterNew York, New York  10021
Walter Reed Army Medical CenterWashington, District of Columbia  20307-5000
University of Chicago Cancer Research CenterChicago, Illinois  60637
University of Massachusetts Memorial Medical CenterWorcester, Massachusetts  01655
Lineberger Comprehensive Cancer Center, UNCChapel Hill, North Carolina  27599-7295
Duke Comprehensive Cancer CenterDurham, North Carolina  27710
Medical University of South CarolinaCharleston, South Carolina  29425-0721
Rhode Island HospitalProvidence, Rhode Island  02903
CCOP - Southern Nevada Cancer Research FoundationLas Vegas, Nevada  89106
University of California San Diego Cancer CenterLa Jolla, California  92093-0658
UCSF Cancer Center and Cancer Research InstituteSan Francisco, California  94115-0128
CCOP - Christiana Care Health ServicesWilmington, Delaware  19899
CCOP - Mount Sinai Medical CenterMiami Beach, Florida  33140
Marlene & Stewart Greenebaum Cancer Center, University of MarylandBaltimore, Maryland  21201
Ellis Fischel Cancer Center - ColumbiaColumbia, Missouri  65203
Barnes-Jewish HospitalSaint Louis, Missouri  63110
Norris Cotton Cancer CenterLebanon, New Hampshire  03756
CCOP - North Shore University HospitalManhasset, New York  11030
State University of New York - Upstate Medical UniversitySyracuse, New York  13210
CCOP - Southeast Cancer Control ConsortiumWinston-Salem, North Carolina  27104-4241
University of Tennessee, Memphis Cancer CenterMemphis, Tennessee  38103
MBCCOP - Massey Cancer CenterRichmond, Virginia  23298-0037
Mount Sinai Medical Center, NYNew York, New York  10029
New York Presbyterian Hospital - Cornell CampusNew York, New York  10021
Holden Comprehensive Cancer Center at The University of IowaIowa City, Iowa  52242-1009
Comprehensive Cancer Center at Wake Forest UniversityWinston-Salem, North Carolina  27157-1082
Veterans Affairs Medical Center - BirminghamBirmingham, Alabama  35233
Veterans Affairs Medical Center - White River JunctionWhite River Junction, Vermont  05009
Dana-Farber Cancer InstituteBoston, Massachusetts  02115
North Shore University HospitalManhasset, New York  11030
Veterans Affairs Medical Center - Chicago (Westside Hospital)Chicago, Illinois  60612
Veterans Affairs Medical Center - San FranciscoSan Francisco, California  94121
CCOP - Syracuse Hematology-Oncology Associates of Central New York, P.C.Syracuse, New York  13217
Veterans Affairs Medical Center - MemphisMemphis, Tennessee  38104
Veterans Affairs Medical Center - RichmondRichmond, Virginia  23249
University of Illinois at Chicago Health Sciences CenterChicago, Illinois  60612
Veterans Affairs Medical Center - TogusTogus, Maine  04330
Veterans Affairs Medical Center - MinneapolisMinneapolis, Minnesota  55417
Veterans Affairs Medical Center - Columbia (Truman Memorial)Columbia, Missouri  65201
University of Nebraska Medical CenterOmaha, Nebraska  68198-3330
Veterans Affairs Medical Center - BuffaloBuffalo, New York  14215
Veterans Affairs Medical Center - SyracuseSyracuse, New York  13210
Veterans Affairs Medical Center - DurhamDurham, North Carolina  27705
Cooper Cancer InstituteCamden, New Jersey  08103
Hematology Oncology Associates of the Quad CitiesBettendorf, Iowa  52722
Howard University Cancer CenterWashington, District of Columbia  20060