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

Sponsored by:	European Organization for Research and Treatment of Cancer
Information provided by:	National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:	NCT00016211

Purpose

RATIONALE: Radiation therapy uses high-energy x-rays to damage tumor cells. Radiation therapy to the brain may be effective in preventing brain metastases. It is not yet known if radiation therapy is effective following chemotherapy in preventing brain metastases.

PURPOSE: Randomized phase III trial to determine the effectiveness of radiation therapy in preventing brain metastases in patients who have received chemotherapy for extensive-stage small cell lung cancer.

Condition	Intervention	Phase
Lung Cancer	Procedure: radiation therapy	Phase III

MedlinePlus related topics: Cancer Lung Cancer

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Active Control
Official Title:	Prophylactic Cranial Irradiation In Extensive Disease Small Cell Lung Cancer

Further study details as provided by National Cancer Institute (NCI):

Primary Outcome Measures:

Time to symptomatic brain metastases measured by Logrank at 6 weeks, every 3 months in year 1, and then every 6 months [ Designated as safety issue: No ]

Secondary Outcome Measures:

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 [ Designated as safety issue: No ]
Toxicity assessed by NCI CTC v2.0 during treatment, at 6 weeks, every 3 months in year 1, and then every 6 months [ Designated as safety issue: Yes ]
Survival measured by Logrank at 6 weeks, every 3 months in year 1, and then every 6 months [ Designated as safety issue: No ]

Study Start Date:

February 2001

Detailed Description:

OBJECTIVES:

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.
Compare the quality of life and survival of these patients.
Determine the toxicity of this regimen in these patients.
Determine the health economics associated with this study.

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.

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

Eligibility

Ages Eligible for Study:	18 Years to 75 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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

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

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00016211

Show 49 Study Locations

Sponsors and Collaborators

European Organization for Research and Treatment of Cancer

Investigators

Investigator:	B.J. Slotman, PhD, MD	Free University Medical Center
Investigator:	Pieter E. Postmus, MD	Free University Medical Center

More Information

Clinical trial summary from the National Cancer Institute's PDQ® database This link exits the ClinicalTrials.gov site

Publications of Results:

Slotman BJ, Mauer ME, Bottomley A, Faivre-Finn C, Kramer GW, Rankin EM, Snee M, Hatton M, Postmus PE, Collette L, Senan S. 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. 2008 Dec 1; [Epub ahead of print]

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, Rankin E, Snee M, Hatton M, Postmus P, Collette L, Musat E, Senan S; EORTC Radiation Oncology Group and Lung Cancer Group. Prophylactic cranial irradiation in extensive small-cell lung cancer. N Engl J Med. 2007 Aug 16;357(7):664-72.

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.

Study ID Numbers:	CDR0000068607, EORTC-RA-22993, EORTC-LCG-08993
Study First Received:	May 6, 2001
Last Updated:	December 12, 2008
ClinicalTrials.gov Identifier:	NCT00016211
Health Authority:	United States: Federal Government

Keywords provided by National Cancer Institute (NCI):

extensive stage small cell lung cancer

Study placed in the following topic categories:

Thoracic Neoplasms
Carcinoma, Neuroendocrine
Carcinoma
Neuroendocrine Tumors
Carcinoma, Small Cell
Neuroectodermal Tumors
Respiratory Tract Diseases

Lung Neoplasms
Lung Diseases
Neoplasms, Germ Cell and Embryonal
Neoplasm Metastasis
Neuroepithelioma
Adenocarcinoma
Neoplasms, Glandular and Epithelial

Additional relevant MeSH terms:

Respiratory Tract Neoplasms
Neoplasms
Neoplasms by Histologic Type
Neoplasms by Site
Neoplasms, Nerve Tissue

ClinicalTrials.gov processed this record on January 16, 2009