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

NCT00016211 | Completed Phase 3

• 3 other identifiers: EORTC-22993-08993EORTC-RA-22993EORTC-LCG-08993
• Study Type: interventional
• Target: 287
• Locations: 12 countries
• Sites: 49

Brief 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.

Conditions

Lung Cancer

Keywords

extensive stage small cell lung cancer

Outcome Measures

Primary Outcomes (1)

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

Secondary Outcomes (3)

• 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

Interventions

radiation therapy RADIATION

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• European Organisation for Research and Treatment of Cancer - EORTC: lead

Study Sites (49)

Ziekenhuis Netwerk Antwerpen Middelheim

Antwerp, 2020, Belgium

Location

Universiteit Gent

Ghent, B-9000, Belgium

Location

Hopital de Jolimont

Haine-Saint-Paul, 7100, Belgium

Location

Cazk Groeninghe - Campus Maria's Voorzienigheid

Kortrijk, B-8500, Belgium

Location

Centre Hospitalier Regional de la Citadelle

Liège, 4000, Belgium

Location

Clinique Saint-Joseph

Liège, B 4000, Belgium

Location

Bank Of Cyprus Oncology Centre

Nicosia, 2006 Strovolos, Cyprus

Location

National Cancer Institute of Egypt

Cairo, Egypt

Location

Institut Gustave Roussy

Villejuif, F-94805, France

Location

Universitaetsklinikum Hamburg-Eppendorf

Hamburg, D-20246, Germany

Location

University of Kaposvar

Kaposvár, 7400, Hungary

Location

Rambam Medical Center

Haifa, 31096, Israel

Location

Ospedale Santa Croce

Cuneo, 12100, Italy

Location

Istituto Nazionale per la Ricerca sul Cancro

Genoa (Genova), 16132, Italy

Location

Azienda Ospedaliera Di Parma

Parma, 43100, Italy

Location

Vrije Universiteit Medisch Centrum

Amsterdam, 1001HV, Netherlands

Location

Academisch Medisch Centrum at University of Amsterdam

Amsterdam, 1105 AZ, Netherlands

Location

Arnhems Radiotherapeutisch Instituut

Arnhem, 6815 AD, Netherlands

Location

Radiotherapeutisch Instituut-(Riso)

Deventer, 7400 AC, Netherlands

Location

University Medical Center Groningen

Groningen, 9700 RB, Netherlands

Location

Radiotherapeutisch Instituut Friesland

Leeuwarden, 8934 AD, Netherlands

Location

Leiden University Medical Center

Leiden, 2300 CA, Netherlands

Location

Nijmegen Cancer Center at Radboud University Medical Center

Nijmegen, NL-6500 HB, Netherlands

Location

University Medical Center Rotterdam at Erasmus Medical Center

Rotterdam, 3000 CA, Netherlands

Location

Erasmus MC - Sophia Children's Hospital

Rotterdam, 3015 GJ, Netherlands

Location

Dr. Bernard Verbeeten Instituut

Tilburg, 5042 SB, Netherlands

Location

Medical University of Gdansk

Gdansk, 80-211, Poland

Location

Marmara University Hospital

Istanbul, 81190, Turkey (Türkiye)

Location

Bristol Haematology and Oncology Centre

Bristol, England, BS2 8ED, United Kingdom

Location

Princess Royal Hospital

Hull, England, HU8 9HE, United Kingdom

Location

Cookridge Hospital at Leeds Teaching Hospital NHS Trust

Leeds, England, LS16 6QB, United Kingdom

Location

Leicester Royal Infirmary

Leicester, England, LE1 5WW, United Kingdom

Location

Christie Hospital N.H.S. Trust

Manchester, England, M20 4BX, United Kingdom

Location

Clatterbridge Centre for Oncology NHS Trust

Merseyside, England, CH63 4JY, United Kingdom

Location

Northern Centre for Cancer Treatment at Newcastle General Hospital

Newcastle upon Tyne, England, NE4 6BE, United Kingdom

Location

Mount Vernon Cancer Centre at Mount Vernon Hospital

Northwood, England, HA6 2RN, United Kingdom

Location

Nottingham City Hospital NHS Trust

Nottingham, England, NG5 1PB, United Kingdom

Location

Cancer Research Centre at Weston Park Hospital

Sheffield, England, S1O 2SJ, United Kingdom

Location

Royal Shrewsbury Hospital

Shrewsbury, England, SY3 8XQ, United Kingdom

Location

Southampton General Hospital

Southampton, England, SO16 6YD, United Kingdom

Location

Royal Marsden NHS Foundation Trust - Surrey

Sutton, England, SM2 5PT, United Kingdom

Location

Southend NHS Trust Hospital

Westcliff-on-Sea, England, SS0 0RY, United Kingdom

Location

Ninewells Hospital and Medical School

Dundee, Scotland, DD1 9SY, United Kingdom

Location

Edinburgh Cancer Centre at Western General Hospital

Edinburgh, Scotland, EH4 2XU, United Kingdom

Location

Western Infirmary

Glasgow, Scotland, G11 6NT, United Kingdom

Location

Raigmore Hospital

Inverness, Scotland, 1V2 3UJ, United Kingdom

Location

Velindre Cancer Center at Velindre Hospital

Cardiff, Wales, CF14 2TL, United Kingdom

Location

Nevill Hall Hospital

Gwent, Wales, United Kingdom

Location

Royal Gwent Hospital

Newport Gwent, Wales, NP9 2UB, United Kingdom

Location

Related Publications (6)

• 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. 2009 Jan 1;27(1):78-84. doi: 10.1200/JCO.2008.17.0746. Epub 2008 Dec 1.

  PMID: 19047288 RESULT

• 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.

  RESULT

• 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. doi: 10.1056/NEJMoa071780.

  PMID: 17699816 RESULT

• 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.

  RESULT

• Bernhardt D, Adeberg S, Bozorgmehr F, Opfermann N, Hoerner-Rieber J, Repka MC, Kappes J, Thomas M, Bischoff H, Herth F, Heussel CP, Debus J, Steins M, Rieken S. Nine-year Experience: Prophylactic Cranial Irradiation in Extensive Disease Small-cell Lung Cancer. Clin Lung Cancer. 2017 Jul;18(4):e267-e271. doi: 10.1016/j.cllc.2016.11.012. Epub 2016 Dec 2.

  PMID: 28027850 DERIVED

• Slotman BJ, Faivre-Finn C, Kramer GW, Rankin E, Snee M, Hatton M, Postmus PE, Collette L, Musat E, Senan S. [Prophylactic cranial irradiation in patients with extensive disease caused by small-cell lung cancer responsive to chemotherapy: fewer symptomatic brain metastases and improved survival]. Ned Tijdschr Geneeskd. 2008 Apr 26;152(17):1000-4. Dutch.

  PMID: 18549175 DERIVED

MeSH Terms

Conditions

Lung Neoplasms

Interventions

Radiotherapy

Condition Hierarchy (Ancestors)

Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Therapeutics

Study Officials

• B.J. Slotman, PhD, MD

  Free University Medical Center

  STUDY CHAIR

• Pieter E. Postmus, MD

  Free University Medical Center

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Purpose: TREATMENT
• Sponsor Type: NETWORK
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 6, 2001
• First Posted: January 27, 2003
• Study Start: February 1, 2001
• Primary Completion: March 1, 2006
• Last Updated: September 24, 2012

Record last verified: 2012-09

Locations

IL (1); GB (21); EG (1); FR (1); HU (1); TU (1); CY (1); DE (1); IT (3); BE (6); NL (11); PL (1)