A Phase II Study Of Accelerated High Dose Thoracic Irradiation With Concurrent Chemotherapy For Patients With Limited Small Cell Lung Cancer


Phase 2
18 Years
N/A
Not Enrolling
Both
Lung Cancer

Thank you

Trial Information

A Phase II Study Of Accelerated High Dose Thoracic Irradiation With Concurrent Chemotherapy For Patients With Limited Small Cell Lung Cancer


OBJECTIVES:

- Determine the response rate of patients with limited stage small cell lung cancer
treated with cisplatin and etoposide combined with accelerated high-dose thoracic
radiotherapy.

- Determine the progression-free and overall survival in patients treated with this
regimen.

- Determine the qualitative and quantitative toxicity and reversibility of toxicity of
this regimen in these patients.

OUTLINE: Patients undergo radiotherapy once daily 5 days a week for approximately 3 weeks
and then twice daily 5 days a week for approximately 2 weeks (a total of 9 treatment days
during the final 2-week treatment period). Beginning on the first day of radiotherapy,
patients receive cisplatin IV over 2 hours and etoposide IV over 1 hour on day 1 and oral
etoposide once daily on days 2 and 3. Chemotherapy repeats every 3 weeks for up to 4 courses
in the absence of disease progression or unacceptable toxicity.

Patients are followed every 3 months for 1 year, every 6 months for 2 years, and then
annually thereafter.

PROJECTED ACCRUAL: A total of 71 patients will be accrued for this study within 18 months.

Inclusion Criteria


DISEASE CHARACTERISTICS:

- Histologically or cytologically confirmed small cell carcinoma of the lung by fine
needle aspiration biopsy or two positive sputa

- Must have limited disease

- Stage I, II, IIIA, or IIIB

- Confined to 1 hemithorax, but excluding the following:

- T4 tumor based on malignant pleural effusion

- N3 disease based on contralateral hilar or supraclavicular involvement

- No pericardial or pleural effusions on chest x-ray (regardless of cytology)

- Measurable or evaluable disease

- Tumor must be able to be encompassed by limited radiotherapy fields without
significantly compromising pulmonary function

- No prior complete tumor resection

PATIENT CHARACTERISTICS:

Age

- 18 to 100

Performance status

- Zubrod 0-1

Life expectancy

- Not specified

Hematopoietic

- Absolute granulocyte count at least 1,500/mm^3

- Platelet count at least 150,000/mm^3

Hepatic

- Bilirubin no greater than 1.5 mg/dL

Renal

- Creatinine no greater than 1.5 mg/dL

Cardiovascular

- No myocardial infarction within the past 6 months

- No symptomatic heart disease

Pulmonary

- No chronic obstructive pulmonary disease with FEV_1 no greater than 0.8 liter

- No uncontrolled bronchospasm in the unaffected lung

Other

- Not pregnant or nursing

- Negative pregnancy test

- Fertile patients must use effective contraception

- Available for follow-up

- No other malignancy within the past 2 years except curatively treated basal cell or
squamous cell skin cancer or non-invasive in situ malignancies

- No other concurrent serious medical illness

- No uncontrolled psychiatric illness

- No chronic alcohol or drug abuse

PRIOR CONCURRENT THERAPY:

Biologic therapy

- Not specified

Chemotherapy

- No prior chemotherapy

Endocrine therapy

- Not specified

Radiotherapy

- No prior radiotherapy to the chest or other area containing a large amount of bone
marrow (e.g., more than 75% of pelvic bone)

Surgery

- See Disease Characteristics

Type of Study:

Interventional

Study Design:

Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Overall survival at 1 and 2 years

Safety Issue:

No

Principal Investigator

Ritsuko U. Komaki, MD, FACR

Investigator Role:

Study Chair

Investigator Affiliation:

M.D. Anderson Cancer Center

Authority:

United States: Federal Government

Study ID:

CDR0000271939

NCT ID:

NCT00066222

Start Date:

June 2003

Completion Date:

Related Keywords:

  • Lung Cancer
  • limited stage small cell lung cancer
  • Lung Neoplasms
  • Small Cell Lung Carcinoma

Name

Location
Akron City Hospital Akron, Ohio  44304
Barbara Ann Karmanos Cancer Institute Detroit, Michigan  48201
Hurley Medical Center Flint, Michigan  48503
CCOP - Illinois Oncology Research Association Peoria, Illinois  61602
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
Gundersen Lutheran Cancer Center at Gundersen Lutheran Medical Center La Crosse, Wisconsin  54601
Rapid City Regional Hospital Rapid City, South Dakota  57709
CCOP - Bay Area Tumor Institute Oakland, California  94609-3305
Memorial Hospital of South Bend South Bend, Indiana  46601
Veterans Affairs Medical Center - Dayton Dayton, Ohio  45428
CCOP - Dayton Kettering, Ohio  45429
Reading Hospital and Medical Center Reading, Pennsylvania  19612-6052
CCOP - MainLine Health Wynnewood, Pennsylvania  19096
LDS Hospital Salt Lake City, Utah  84143
CCOP - Northern Indiana CR Consortium South Bend, Indiana  46601
Saint Joseph Regional Medical Center South Bend, Indiana  46617
Siteman Cancer Center at Barnes-Jewish Hospital Saint Louis, Missouri  63110
Charles M. Barrett Cancer Center at University Hospital Cincinnati, Ohio  45267-0526
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins Baltimore, Maryland  21231-2410
Cleveland Clinic Taussig Cancer Center Cleveland, Ohio  44195
Utah Valley Regional Medical Center - Provo Provo, Utah  84604
Markey Cancer Center at University of Kentucky Chandler Medical Center Lexington, Kentucky  40536-0084
Josephine Ford Cancer Center at Henry Ford Hospital Detroit, Michigan  48202
M.D. Anderson Cancer Center at University of Texas Houston, Texas  77030
Comprehensive Cancer Center at University of Alabama at Birmingham Birmingham, Alabama  35294
Curtis & Elizabeth Anderson Cancer Institute at Memorial Health University Medical Center Savannah, Georgia  31403-3089
Aultman Hospital Cancer Center at Aultman Health Foundation Canton, Ohio  44710-1799
St. Agnes Cancer Center Baltimore, Maryland  21229
Wayne Memorial Hospital, Incorporated Goldsboro, North Carolina  27534
Cottonwood Hospital Medical Center Murray, Utah  84107
McKay-Dee Hospital Center Ogden, Utah  84403
Utah Cancer Specialists at UCS Cancer Center Salt Lake City, Utah  84106
Lakeland Cancer Care Center at Lakeland Hospital - St. Joseph Saint Joseph, Michigan  49085
Paoli Memorial Hospital Paoli, Pennsylvania  19301-1792
Elkhart General Hospital Elkhart, Indiana  46515
Hillcrest Cancer Center at Hillcrest Hospital Mayfield Heights, Ohio  44124
Eden Medical Center Castro Valley, California  94546
Saint Rose Hospital Hayward, California  94545
Highland General Hospital at St. George's University School of Medicine Oakland, California  94602
Alta Bates Summit Medical Center - Summit Campus Oakland, California  94609
Valley Care Medical Center Pleasanton, California  94588
J.C. Robinson, M.D. Regional Cancer Center San Pablo, California  94806
St. Joseph Medical Center Bloomington, Illinois  61701
Graham Hospital Canton, Illinois  61520
Memorial Hospital Carthage, Illinois  62321
Eureka Community Hospital Eureka, Illinois  61530
Galesburg Cottage Hospital Galesburg, Illinois  61401
Galesburg Clinic Galesburg, Illinois  61401
Mason District Hospital Havana, Illinois  62644
Kewanee Hospital Kewanee, Illinois  61443
McDonough District Hospital Macomb, Illinois  61455
BroMenn Regional Medical Center Normal, Illinois  61761
Community Cancer Center Normal, Illinois  61761
Community Hospital of Ottawa Ottawa, Illinois  61350
Oncology Hematology Associates of Central Illinois, PC - Ottawa Ottawa, Illinois  61350
Cancer Treatment Center at Pekin Hospital Pekin, Illinois  61554
Oncology Hematology Associates of Central Illinois, PC - Peoria Peoria, Illinois  61615
OSF St. Francis Medical Center Peoria, Illinois  61637
Illinois Valley Community Hospital Peru, Illinois  61354
Perry Memorial Hospital Princeton, Illinois  61356
St. Margaret's Hospital Spring Valley, Illinois  61362
St. Francis Hospital and Health Centers - Beech Grove Campus Beech Grove, Indiana  46107
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
St. Joseph Mercy Cancer Center at St. Joseph Mercy Hospital Ann Arbor, Michigan  48106-0995
Fox Chase Cancer Center at St. Francis Medical Center Trenton, New Jersey  08629
Wayne Radiation Oncology Goldsboro, North Carolina  27534
Samaritan North Cancer Care Center Dayton, Ohio  45415
Grandview Hospital Dayton, Ohio  45405
David L. Rike Cancer Center at Miami Valley Hospital Dayton, Ohio  45409
Good Samaritan Hospital Dayton, Ohio  45406
Charles F. Kettering Memorial Hospital Kettering, Ohio  45429
Middletown Regional Hospital Middletown, Ohio  45044
UVMC Cancer Care Center at Upper Valley Medical Center Troy, Ohio  45373-1300
Ruth G. McMillan Cancer Center at Greene Memorial Hospital Xenia, Ohio  45385
Bryn Mawr Hospital Bryn Mawr, Pennsylvania  19010
Lankenau Cancer Center at Lankenau Hospital Wynnewood, Pennsylvania  19096
Dixie Regional Medical Center - East Campus Saint George, Utah  84770
Wendt Regional Cancer Center at Finley Hospital Dubuque, Iowa  52001
Cancer Treatment Center at the Medical Center - Bowling Green Bowling Green, Kentucky  42101
South Jersey Healthcare Regional Cancer Center Millville, New Jersey  08332
Huron Hospital Cancer Care Center Cleveland, Ohio  44112
Euclid Hospital Cleveland, Ohio  44119
Cancer Research UK Medical Oncology Unit at Churchill Hospital & Weatherall Institute of Molecular Medicine - Oxford Salem, Ohio  44460
South Pointe Hospital Cancer Care Center Warrensville Heights, Ohio  44122
Cancer Treatment Center Wooster, Ohio  44691
Schiffler Cancer Center at Wheeling Hospital Wheeling, West Virginia  26003
Saint Louis University Cancer Center Saint Louis, Missouri  63110
Robert and Beverly Lewis Family Cancer Care Center at Pomona Valley Hospital Medical Center Pomona, California  91767
Wilmed Radiation Oncology Services Wilson, North Carolina  27893
Columbia St. Mary's Cancer Care Center Milwaukee, Wisconsin  53211
J. Phillip Citta Regional Cancer Center at Community Medical Center Toms River, New Jersey  08755
Veterans Affairs Medical Center - Milwaukee Milwaukee, Wisconsin  53295
Fitzpatrick Cancer Center at Champlain Valley Physicians Hospital Medical Center Plattsburgh, New York  12901