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A Phase II/III Randomized Trial Of Two Dose Schedules For Delivering Prophylactic Cranial Irradiation For Patients With Limited Disease Small Cell Lung Cancer

Phase 2/Phase 3
Not Enrolling
Lung Cancer

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Trial Information

A Phase II/III Randomized Trial Of Two Dose Schedules For Delivering Prophylactic Cranial Irradiation For Patients With Limited Disease Small Cell Lung Cancer


- Compare the incidence of brain metastases in patients with limited stage small cell
lung cancer treated with different regimens of prophylactic cranial irradiation. (phase
III closed to accrual as of 12/31/05)

- Compare the overall and disease-free survival of patients treated with these regimens.
(phase III closed to accrual as of 12/31/05)

- Compare the incidence of chronic neurotoxicity in patients treated with these regimens.

- Compare quality of life and late treatment sequelae of patients treated with these
regimens. (phase III closed to accrual as of 12/31/05)

OUTLINE: This is a randomized, multicenter study. Patients are stratified according to age
(60 and under vs over 60) and time since induction therapy (90 days or less vs 91-180 days
vs 181-240 days). Patients are randomized to 1 of 3 treatment arms.

- Arm I: Patients undergo prophylactic cranial irradiation (PCI) once daily 5 days a
week. Treatment continues for 2 weeks in the absence of unacceptable toxicity.

- Arm II: Patients undergo PCI once daily 5 days a week. Treatment continues for 2.6
weeks in the absence of unacceptable toxicity.

- Arm III: Patients undergo PCI twice daily 5 days a week. Treatment continues for 3.4
weeks in the absence of unacceptable toxicity.

Quality of life is assessed at baseline, every 6 months for 1 year, and then annually for 3

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

PROJECTED ACCRUAL: A total of 264 patients will be accrued for this study within 3.5 years.

Inclusion Criteria


- Histologically or cytologically confirmed small cell lung cancer by fine needle
aspiration, biopsy, or 2 positive sputa

- Limited stage (I-IIIB)

- Confined to 1 hemithorax

- No T4 or N3 disease

- Complete response after induction chemotherapy (with or without thoracic

- Consolidative chest radiotherapy may be initiated before study

- No radiographic evidence of any of the following:

- Brain metastases

- Normal brain CT scan or MRI less than 1 month before study

- Ipsilateral lung metastases

- Malignant pleural effusion

- Minimal pleural effusion by chest CT scan allowed, but not by chest x-ray



- Not specified

Performance status

- Zubrod 0-1

Life expectancy

- Not specified


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

- Platelet count at least 75,000/mm^3

- Hemoglobin at least 10.0 g/dL^


- Not specified


- Not specified


- See Disease Characteristics


- Not pregnant or nursing

- Fertile patients must use effective contraception

- Neurological function class 1 or 2

- No epilepsy requiring permanent oral medication

- No other malignancy within the past 5 years except nonmelanoma skin cancer or
carcinoma in situ of the cervix

- No other serious medical or psychiatric condition that would preclude study


Biologic therapy

- Not specified


- See Disease Characteristics

- At least 1 week since prior chemotherapy

- No concurrent chemotherapy

Endocrine therapy

- Not specified


- See Disease Characteristics

- No prior external beam radiotherapy to the head or neck, including stereotactic

- Concurrent thoracic radiotherapy allowed


- Not specified


- No concurrent antitumor agents

Type of Study:


Study Design:

Allocation: Randomized, Primary Purpose: Treatment

Outcome Measure:

Incidence of brain metastases (Phase III patients enrolled before 12/31/05)

Safety Issue:


Principal Investigator

Aaron H. Wolfson, MD

Investigator Role:

Study Chair

Investigator Affiliation:

University of Miami Sylvester Comprehensive Cancer Center


United States: Federal Government

Study ID:




Start Date:

February 2003

Completion Date:

Related Keywords:

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



Roswell Park Cancer Institute Buffalo, New York  14263
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University of Florida Shands Cancer Center Gainesville, Florida  32610-0232
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InterCommunity Cancer Center of Western Illinois Galesburg, Illinois  61401
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Huron Hospital Cancer Care Center Cleveland, Ohio  44112
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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
Tunnell Cancer Center at Beebe Medical Center Lewes, Delaware  19958
University of Miami Sylvester Comprehensive Cancer Center - Miami Miami, Florida  33136
McFarland Clinic, PC Ames, Iowa  50010
Cancer Center of Kansas, PA - Chanute Chanute, Kansas  66720
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Cotton-O'Neil Cancer Center Topeka, Kansas  66606
Cancer Center of Kansas, PA - Wellington Wellington, Kansas  67152
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Associates in Womens Health, PA - North Review Wichita, Kansas  67208
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Union Hospital Cancer Program at Union Hospital Elkton MD, Maryland  21921
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Leo W. Jenkins Cancer Center at ECU Medical School Greenville, North Carolina  27834
Summa Center for Cancer Care at Akron City Hospital Akron, Ohio  44309-2090
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York Cancer Center at Apple Hill Medical Center York, Pennsylvania  17405
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St. Joseph Cancer Center Bellingham, Washington  98225
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Schiffler Cancer Center at Wheeling Hospital Wheeling, West Virginia  26003
Fox Chase Cancer Center CCOP Research Base Philadelphia, Pennsylvania  19140
Lurleen Wallace Comprehensive Cancer at University of Alabama - Birmingham Birmingham, Alabama  35294
Arizona Oncology Services Foundation Phoenix, Arizona  85013
Robert and Beverly Lewis Family Cancer Care Center at Pomona Valley Hospital Medical Center Pomona, California  91767
Radiological Associates of Sacramento Medical Group, Incorporated Sacramento, California  95815
Parkview Regional Cancer Center at Parkview Health Fort Wayne, Indiana  46805
Tucker Center for Cancer Care at Orange Regional Medical Center Middletown, New York  10940-4199
Three Rivers Community Hospital Grants Pass, Oregon  97527
Dubs Cancer Center at Rogue Valley Medical Center Medford, Oregon  97504
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La Grange Memorial Hospital La Grange, Illinois  60525
Lacks Cancer Center at Saint Mary's Health Care Grand Rapids, Michigan  49503
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Solano Radiation Oncology Center Vacaville, California  95687
Franklin & Edith Scarpa Regional Cancer Center at South Jersey Healthcare Vineland, New Jersey  08360
Galesburg Clinic, PC Galesburg, Illinois  61401
Boston University Cancer Research Center Boston, Massachusetts  02118
Mercy General Hospital Sacramento, California  95819
Virginia G. Piper Cancer Center at Scottsdale Healthcare - Shea Scottsdale, Arizona  85260
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Dale and Frances Hughes Cancer Center at Pocono Medical Center East Stroudsburg, Pennsylvania  18301
Bay Medical Panama City, Florida  32401
Cancer Institute of Cape Girardeau, LLC Cape Girardeau, Missouri  63703
Ocean Medical Center at Meridian Health Brick, New Jersey  08724
J. Phillip Citta Regional Cancer Center at Community Medical Center Toms River, New Jersey  08755
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Veterans Affairs Medical Center - Milwaukee Milwaukee, Wisconsin  53295
Memorial Hospital Cancer Center - Colorado Springs Colorado Springs, Colorado  80909
Hudner Oncology Center at Saint Anne's Hospital - Fall River Fall River, Massachusetts  02721
Immanuel St. Joseph's Mankato, Minnesota  56002
Arlington Cancer Center - Arlington Arlington, Texas  76012
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Radiation Oncology Centers - Cameron Park Cameron Park, California  95682
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Saint John's Cancer Center at Saint John's Medical Center Anderson, Indiana  46016
Radiation Oncology Associates - Reno Reno, Nevada  89509
Hudson Valley Oncology Associates Poughkeepsie, New York  12601
Harrison Medical Center Bremerton, Washington  98310