Alternate Title
Basic Trial Information
Objectives
Entry Criteria
Expected Enrollment
Outcomes
Outline
Published Results
Trial Contact Information
Registry Information

Alternate Title

Radiation Therapy to Prevent Brain Metastases in Patients With Previously Treated Extensive-Stage Small Cell Lung Cancer

Basic Trial Information

Phase	Type	Status	Age	Sponsor	Protocol IDs
Phase III	Treatment	Closed	18 to 75	Other	EORTC-RA-22993 EORTC-LCG-08993, NCT00016211

Objectives

1. Compare the incidence of, and time to, symptomatic brain metastases in patients with previously treated extensive stage small cell lung cancer treated with prophylactic cranial irradiation vs no further therapy.
2. Compare the quality of life and survival of these patients.
3. Determine the toxicity of this regimen in these patients.
4. Determine the health economics associated with this study.

Entry Criteria

Disease Characteristics:

• Cytologically or histologically confirmed small cell lung cancer
  • Documented extensive disease before the initiation of chemotherapy



• Responsive disease after 4 to 6 courses of initial chemotherapy
  • No more than 5 weeks since completion of prior chemotherapy



• No brain or leptomeningeal metastases

Prior/Concurrent Therapy:

Biologic therapy:

• Not specified

Chemotherapy:

• See Disease Characteristics

Endocrine therapy:

• No concurrent corticosteroids

Radiotherapy:

• No prior radiotherapy to the brain
• No prior radiotherapy to the head and neck

Surgery:

• Not specified

Patient Characteristics:

Age:

• 18 to 75

Performance status:

• WHO 0-2

Life expectancy:

• Not specified

Hematopoietic:

• Not specified

Hepatic:

• Not specified

Renal:

• Not specified

Other:

• No other prior or concurrent malignancy except skin cancer or carcinoma in situ of the cervix
• No psychological, familial, sociological, or geographical condition that would preclude study compliance

Expected Enrollment

A total of 287 patients will be accrued for this study within 3 years.

Outcomes

Time to symptomatic brain metastases measured by Logrank at 6 weeks, every 3 months in year 1, and then every 6 months

Quality of life assessed by EORTC QLQ-C30 and EORTC BN-20 at baseline, 6 weeks, every 3 months in year 1, and then every 6 months
Toxicity assessed by NCI CTC v2.0 during treatment, at 6 weeks, every 3 months in year 1, and then every 6 months
Survival measured by Logrank at 6 weeks, every 3 months in year 1, and then every 6 months

Outline

This is a randomized, multicenter study. Patients are stratified according to participating center and performance status. Patients are randomized to 1 of 2 treatment arms.

• Arm I: Within 5 weeks after completion of prior chemotherapy, patients undergo prophylactic cranial irradiation once daily for 5-12 days.



• Arm II: Patients receive no further therapy after completion of prior chemotherapy.

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

Patients are followed at 6 weeks, every 3 months for 1 year, and then every 6 months thereafter.

Slotman BJ, Mauer ME, Bottomley A, et al.: Prophylactic cranial irradiation in extensive disease small-cell lung cancer: short-term health-related quality of life and patient reported symptoms: results of an international Phase III randomized controlled trial by the EORTC Radiation Oncology and Lung Cancer Groups. J Clin Oncol 27 (1): 78-84, 2009.[PUBMED Abstract]

Slotman B, Faivre-Finn C, Kramer G, et al.: A randomized trial of prophylactic cranial irradiation (PCI) versus no PCI in extensive disease small cell lung cancer after a response to chemotherapy (EORTC 08993-22993). [Abstract] J Clin Oncol 25 (Suppl 18): A-4, 2s, 2007.

Slotman B, Faivre-Finn C, Kramer G, et al.: Prophylactic cranial irradiation in extensive small-cell lung cancer. N Engl J Med 357 (7): 664-72, 2007.[PUBMED Abstract]

Slotman BJ, Faivre-Finn C, Kramer GWPM, et al.: Prophylactic cranial irradiation (PCI) in extensive stage small cell lung cancer (ES-SCLC) (EORTC 22993-08993). [Abstract] Int J Radiat Oncol Biol Phys 69 (3 Suppl): A-7, S4, 2007.

Trial Contact Information

Trial Lead Organizations

European Organization for Research and Treatment of Cancer

B.J. Slotman, PhD, MD, Study coordinator		Ph: 31-20-444-0414 Email: bj.slotman@vumc.nl
Pieter Postmus, MD, Study coordinator		Ph: 31-20-444-4782 Email: pe.postmus@vumc.nl

Registry Information
Official Title		Prophylactic Cranial Irradiation In Extensive Disease Small Cell Lung Cancer
Trial Start Date		2001-02-28
Registered in ClinicalTrials.gov		NCT00016211
Date Submitted to PDQ		2001-03-13
Information Last Verified		2006-01-05