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A Randomized, Phase III Dose Response Study of Prophylactic Cranial Irradiation (PCI) for Small Cell Carcinoma of the Lung


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

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Trial Information

A Randomized, Phase III Dose Response Study of Prophylactic Cranial Irradiation (PCI) for Small Cell Carcinoma of the Lung


OBJECTIVES: I. Compare the efficacy of low dose versus high dose prophylactic cranial
irradiation in preventing brain metastases in patients with small cell carcinoma of the
lung. II. Determine the neuropsychiatric status of these patients before and after
treatment.

OUTLINE: This is a randomized, multicenter study. The right or left hemisphere of each
patient's brain are randomized to one of two treatment arms. All patients receive whole
brain radiotherapy 5 days a week over 2.5 weeks for a total of 12 fractions. Arm I: Patients
receive radiotherapy to the left cerebral hemisphere daily for 6 days immediately following
completion of whole brain radiotherapy. Arm II: Patients receive radiotherapy to the right
cerebral hemisphere daily for 6 days immediately following completion of whole brain
radiotherapy. Patients with extensive disease may also receive thoracic radiotherapy, if not
administered previously. Patients are followed at 1, 3, 6, 9, and 12 months, and then every
6 months thereafter.

PROJECTED ACCRUAL: Approximately 16-40 patients will be accrued for this study within 1-4
years.

Inclusion Criteria


DISEASE CHARACTERISTICS: Histologically confirmed small cell carcinoma of the lung
diagnosed within the past year Limited stage Must have completed prior chemotherapy with
thoracic irradiation Extensive stage Must have completed prior chemotherapy with or
without thoracic irradiation No more than 24 Gy of prior prophylactic cranial irradiation
to the whole brain No brain metastases

PATIENT CHARACTERISTICS: Age: Not specified Performance status: Karnofsky 50-100% Life
expectancy: Not specified Hematopoietic: Not specified Hepatic: Not specified Renal: Not
specified Other: No other prior malignancy within the past 3 years except the following:
Adequately treated basal cell or squamous cell skin cancer Carcinoma in situ of the cervix
Not pregnant or nursing Negative pregnancy test Fertile patients must use effective
contraception

PRIOR CONCURRENT THERAPY: Biologic therapy: Not specified Chemotherapy: See Disease
Characteristics Endocrine therapy: Not specified Radiotherapy: See Disease Characteristics
Surgery: Not specified

Type of Study:

Interventional

Study Design:

Endpoint Classification: Bio-equivalence Study, Intervention Model: Parallel Assignment, Primary Purpose: Treatment

Principal Investigator

Brian Kavanagh, MD

Investigator Role:

Study Chair

Investigator Affiliation:

Massey Cancer Center

Authority:

United States: Federal Government

Study ID:

CDR0000068152

NCT ID:

NCT00006344

Start Date:

May 2000

Completion Date:

December 2000

Related Keywords:

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

Name

Location

Massey Cancer CenterRichmond, Virginia  23298-0037