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

Lung Cancer Clinical Trial

Official title:

Prophylactic Cranial Irradiation In Extensive Disease Small Cell Lung Cancer

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00016211
• Other study ID #: EORTC-22993-08993
• Secondary ID: EORTC-RA-22993EO
• Status: Completed
• Phase: Phase 3
• First received: May 6, 2001
• Last updated: September 20, 2012
• Start date: February 2001

Study information

• Verified date: September 2012
• Source: European Organisation for Research and Treatment of Cancer - EORTC
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 287
• Est. primary completion date: March 2006
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 75 Years

Eligibility

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

Study Design

Allocation: Randomized, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Lung Cancer
• Lung Neoplasms
• Small Cell Lung Carcinoma

Intervention

Radiation:
• radiation therapy

Locations

Country	Name	City	State
Belgium	Ziekenhuis Netwerk Antwerpen Middelheim	Antwerp
Belgium	Universiteit Gent	Ghent
Belgium	Hopital de Jolimont	Haine Saint Paul
Belgium	Cazk Groeninghe - Campus Maria's Voorzienigheid	Kortrijk
Belgium	Centre Hospitalier Regional de la Citadelle	Liege
Belgium	Clinique Saint-Joseph	Liege
Cyprus	Bank Of Cyprus Oncology Centre	Nicosia
Egypt	National Cancer Institute of Egypt	Cairo
France	Institut Gustave Roussy	Villejuif
Germany	Universitaetsklinikum Hamburg-Eppendorf	Hamburg
Hungary	University of Kaposvar	Kaposvar
Israel	Rambam Medical Center	Haifa
Italy	Ospedale Santa Croce	Cuneo
Italy	Istituto Nazionale per la Ricerca sul Cancro	Genoa (Genova)
Italy	Azienda Ospedaliera Di Parma	Parma
Netherlands	Academisch Medisch Centrum at University of Amsterdam	Amsterdam
Netherlands	Vrije Universiteit Medisch Centrum	Amsterdam
Netherlands	Arnhems Radiotherapeutisch Instituut	Arnhem
Netherlands	Radiotherapeutisch Instituut-(Riso)	Deventer
Netherlands	University Medical Center Groningen	Groningen
Netherlands	Radiotherapeutisch Instituut Friesland	Leeuwarden
Netherlands	Leiden University Medical Center	Leiden
Netherlands	Nijmegen Cancer Center at Radboud University Medical Center	Nijmegen
Netherlands	Erasmus MC - Sophia Children's Hospital	Rotterdam
Netherlands	University Medical Center Rotterdam at Erasmus Medical Center	Rotterdam
Netherlands	Dr. Bernard Verbeeten Instituut	Tilburg
Poland	Medical University of Gdansk	Gdansk
Turkey	Marmara University Hospital	Istanbul
United Kingdom	Bristol Haematology and Oncology Centre	Bristol	England
United Kingdom	Velindre Cancer Center at Velindre Hospital	Cardiff	Wales
United Kingdom	Ninewells Hospital and Medical School	Dundee	Scotland
United Kingdom	Edinburgh Cancer Centre at Western General Hospital	Edinburgh	Scotland
United Kingdom	Western Infirmary	Glasgow	Scotland
United Kingdom	Nevill Hall Hospital	Gwent	Wales
United Kingdom	Princess Royal Hospital	Hull	England
United Kingdom	Raigmore Hospital	Inverness	Scotland
United Kingdom	Cookridge Hospital at Leeds Teaching Hospital NHS Trust	Leeds	England
United Kingdom	Leicester Royal Infirmary	Leicester	England
United Kingdom	Christie Hospital N.H.S. Trust	Manchester	England
United Kingdom	Clatterbridge Centre for Oncology NHS Trust	Merseyside	England
United Kingdom	Northern Centre for Cancer Treatment at Newcastle General Hospital	Newcastle Upon Tyne	England
United Kingdom	Royal Gwent Hospital	Newport Gwent	Wales
United Kingdom	Mount Vernon Cancer Centre at Mount Vernon Hospital	Northwood	England
United Kingdom	Nottingham City Hospital NHS Trust	Nottingham	England
United Kingdom	Cancer Research Centre at Weston Park Hospital	Sheffield	England
United Kingdom	Royal Shrewsbury Hospital	Shrewsbury	England
United Kingdom	Southampton General Hospital	Southampton	England
United Kingdom	Royal Marsden NHS Foundation Trust - Surrey	Sutton	England
United Kingdom	Southend NHS Trust Hospital	Westcliff-On-Sea	England

Sponsors (1)

Lead Sponsor	Collaborator
European Organisation for Research and Treatment of Cancer - EORTC

Countries where clinical trial is conducted

Belgium,  Cyprus,  Egypt,  France,  Germany,  Hungary,  Israel,  Italy,  Netherlands,  Poland,  Turkey,  United Kingdom, 

References & Publications (4)

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):

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; — View Citation

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.

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 — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Time to symptomatic brain metastases measured by Logrank at 6 weeks, every 3 months in year 1, and then every 6 months			No
Secondary	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			No
Secondary	Toxicity assessed by NCI CTC v2.0 during treatment, at 6 weeks, every 3 months in year 1, and then every 6 months			Yes
Secondary	Survival measured by Logrank at 6 weeks, every 3 months in year 1, and then every 6 months			No