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

Primary Purpose

Lung Cancer

Status
Completed
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
radiation therapy
Sponsored by
European Organisation for Research and Treatment of Cancer - EORTC
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Lung Cancer focused on measuring extensive stage small cell lung cancer

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Ziekenhuis Netwerk Antwerpen Middelheim
  • Universiteit Gent
  • Hopital de Jolimont
  • Cazk Groeninghe - Campus Maria's Voorzienigheid
  • Centre Hospitalier Regional de la Citadelle
  • Clinique Saint-Joseph
  • Bank Of Cyprus Oncology Centre
  • National Cancer Institute of Egypt
  • Institut Gustave Roussy
  • Universitaetsklinikum Hamburg-Eppendorf
  • University of Kaposvar
  • Rambam Medical Center
  • Ospedale Santa Croce
  • Istituto Nazionale per la Ricerca sul Cancro
  • Azienda Ospedaliera Di Parma
  • Vrije Universiteit Medisch Centrum
  • Academisch Medisch Centrum at University of Amsterdam
  • Arnhems Radiotherapeutisch Instituut
  • Radiotherapeutisch Instituut-(Riso)
  • University Medical Center Groningen
  • Radiotherapeutisch Instituut Friesland
  • Leiden University Medical Center
  • Nijmegen Cancer Center at Radboud University Medical Center
  • University Medical Center Rotterdam at Erasmus Medical Center
  • Erasmus MC - Sophia Children's Hospital
  • Dr. Bernard Verbeeten Instituut
  • Medical University of Gdansk
  • Marmara University Hospital
  • Bristol Haematology and Oncology Centre
  • Princess Royal Hospital
  • Cookridge Hospital at Leeds Teaching Hospital NHS Trust
  • Leicester Royal Infirmary
  • Christie Hospital N.H.S. Trust
  • Clatterbridge Centre for Oncology NHS Trust
  • Northern Centre for Cancer Treatment at Newcastle General Hospital
  • Mount Vernon Cancer Centre at Mount Vernon Hospital
  • Nottingham City Hospital NHS Trust
  • Cancer Research Centre at Weston Park Hospital
  • Royal Shrewsbury Hospital
  • Southampton General Hospital
  • Royal Marsden NHS Foundation Trust - Surrey
  • Southend NHS Trust Hospital
  • Ninewells Hospital and Medical School
  • Edinburgh Cancer Centre at Western General Hospital
  • Western Infirmary
  • Raigmore Hospital
  • Velindre Cancer Center at Velindre Hospital
  • Nevill Hall Hospital
  • Royal Gwent Hospital

Outcomes

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

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
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

Full Information

First Posted
May 6, 2001
Last Updated
September 20, 2012
Sponsor
European Organisation for Research and Treatment of Cancer - EORTC
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1. Study Identification

Unique Protocol Identification Number
NCT00016211
Brief Title
Radiation Therapy to Prevent Brain Metastases in Patients With Previously Treated Extensive-Stage Small Cell Lung Cancer
Official Title
Prophylactic Cranial Irradiation In Extensive Disease Small Cell Lung Cancer
Study Type
Interventional

2. Study Status

Record Verification Date
September 2012
Overall Recruitment Status
Completed
Study Start Date
February 2001 (undefined)
Primary Completion Date
March 2006 (Actual)
Study Completion Date
undefined (undefined)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
European Organisation for Research and Treatment of Cancer - EORTC

4. Oversight

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Lung Cancer
Keywords
extensive stage small cell lung cancer

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Allocation
Randomized
Enrollment
287 (Actual)

8. Arms, Groups, and Interventions

Intervention Type
Radiation
Intervention Name(s)
radiation therapy
Primary Outcome Measure Information:
Title
Time to symptomatic brain metastases measured by Logrank at 6 weeks, every 3 months in year 1, and then every 6 months
Secondary Outcome Measure Information:
Title
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
Title
Toxicity assessed by NCI CTC v2.0 during treatment, at 6 weeks, every 3 months in year 1, and then every 6 months
Title
Survival measured by Logrank at 6 weeks, every 3 months in year 1, and then every 6 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
B.J. Slotman, PhD, MD
Organizational Affiliation
Free University Medical Center
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Pieter E. Postmus, MD
Organizational Affiliation
Free University Medical Center
Official's Role
Study Chair
Facility Information:
Facility Name
Ziekenhuis Netwerk Antwerpen Middelheim
City
Antwerp
ZIP/Postal Code
2020
Country
Belgium
Facility Name
Universiteit Gent
City
Ghent
ZIP/Postal Code
B-9000
Country
Belgium
Facility Name
Hopital de Jolimont
City
Haine Saint Paul
ZIP/Postal Code
7100
Country
Belgium
Facility Name
Cazk Groeninghe - Campus Maria's Voorzienigheid
City
Kortrijk
ZIP/Postal Code
B-8500
Country
Belgium
Facility Name
Centre Hospitalier Regional de la Citadelle
City
Liege
ZIP/Postal Code
4000
Country
Belgium
Facility Name
Clinique Saint-Joseph
City
Liege
ZIP/Postal Code
B 4000
Country
Belgium
Facility Name
Bank Of Cyprus Oncology Centre
City
Nicosia
ZIP/Postal Code
2006 Strovolos
Country
Cyprus
Facility Name
National Cancer Institute of Egypt
City
Cairo
Country
Egypt
Facility Name
Institut Gustave Roussy
City
Villejuif
ZIP/Postal Code
F-94805
Country
France
Facility Name
Universitaetsklinikum Hamburg-Eppendorf
City
Hamburg
ZIP/Postal Code
D-20246
Country
Germany
Facility Name
University of Kaposvar
City
Kaposvar
ZIP/Postal Code
7400
Country
Hungary
Facility Name
Rambam Medical Center
City
Haifa
ZIP/Postal Code
31096
Country
Israel
Facility Name
Ospedale Santa Croce
City
Cuneo
ZIP/Postal Code
12100
Country
Italy
Facility Name
Istituto Nazionale per la Ricerca sul Cancro
City
Genoa (Genova)
ZIP/Postal Code
16132
Country
Italy
Facility Name
Azienda Ospedaliera Di Parma
City
Parma
ZIP/Postal Code
43100
Country
Italy
Facility Name
Vrije Universiteit Medisch Centrum
City
Amsterdam
ZIP/Postal Code
1001HV
Country
Netherlands
Facility Name
Academisch Medisch Centrum at University of Amsterdam
City
Amsterdam
ZIP/Postal Code
1105 AZ
Country
Netherlands
Facility Name
Arnhems Radiotherapeutisch Instituut
City
Arnhem
ZIP/Postal Code
6815 AD
Country
Netherlands
Facility Name
Radiotherapeutisch Instituut-(Riso)
City
Deventer
ZIP/Postal Code
7400 AC
Country
Netherlands
Facility Name
University Medical Center Groningen
City
Groningen
ZIP/Postal Code
9700 RB
Country
Netherlands
Facility Name
Radiotherapeutisch Instituut Friesland
City
Leeuwarden
ZIP/Postal Code
8934 AD
Country
Netherlands
Facility Name
Leiden University Medical Center
City
Leiden
ZIP/Postal Code
2300 CA
Country
Netherlands
Facility Name
Nijmegen Cancer Center at Radboud University Medical Center
City
Nijmegen
ZIP/Postal Code
NL-6500 HB
Country
Netherlands
Facility Name
University Medical Center Rotterdam at Erasmus Medical Center
City
Rotterdam
ZIP/Postal Code
3000 CA
Country
Netherlands
Facility Name
Erasmus MC - Sophia Children's Hospital
City
Rotterdam
ZIP/Postal Code
3015 GJ
Country
Netherlands
Facility Name
Dr. Bernard Verbeeten Instituut
City
Tilburg
ZIP/Postal Code
5042 SB
Country
Netherlands
Facility Name
Medical University of Gdansk
City
Gdansk
ZIP/Postal Code
80-211
Country
Poland
Facility Name
Marmara University Hospital
City
Istanbul
ZIP/Postal Code
81190
Country
Turkey
Facility Name
Bristol Haematology and Oncology Centre
City
Bristol
State/Province
England
ZIP/Postal Code
BS2 8ED
Country
United Kingdom
Facility Name
Princess Royal Hospital
City
Hull
State/Province
England
ZIP/Postal Code
HU8 9HE
Country
United Kingdom
Facility Name
Cookridge Hospital at Leeds Teaching Hospital NHS Trust
City
Leeds
State/Province
England
ZIP/Postal Code
LS16 6QB
Country
United Kingdom
Facility Name
Leicester Royal Infirmary
City
Leicester
State/Province
England
ZIP/Postal Code
LE1 5WW
Country
United Kingdom
Facility Name
Christie Hospital N.H.S. Trust
City
Manchester
State/Province
England
ZIP/Postal Code
M20 4BX
Country
United Kingdom
Facility Name
Clatterbridge Centre for Oncology NHS Trust
City
Merseyside
State/Province
England
ZIP/Postal Code
CH63 4JY
Country
United Kingdom
Facility Name
Northern Centre for Cancer Treatment at Newcastle General Hospital
City
Newcastle Upon Tyne
State/Province
England
ZIP/Postal Code
NE4 6BE
Country
United Kingdom
Facility Name
Mount Vernon Cancer Centre at Mount Vernon Hospital
City
Northwood
State/Province
England
ZIP/Postal Code
HA6 2RN
Country
United Kingdom
Facility Name
Nottingham City Hospital NHS Trust
City
Nottingham
State/Province
England
ZIP/Postal Code
NG5 1PB
Country
United Kingdom
Facility Name
Cancer Research Centre at Weston Park Hospital
City
Sheffield
State/Province
England
ZIP/Postal Code
S1O 2SJ
Country
United Kingdom
Facility Name
Royal Shrewsbury Hospital
City
Shrewsbury
State/Province
England
ZIP/Postal Code
SY3 8XQ
Country
United Kingdom
Facility Name
Southampton General Hospital
City
Southampton
State/Province
England
ZIP/Postal Code
SO16 6YD
Country
United Kingdom
Facility Name
Royal Marsden NHS Foundation Trust - Surrey
City
Sutton
State/Province
England
ZIP/Postal Code
SM2 5PT
Country
United Kingdom
Facility Name
Southend NHS Trust Hospital
City
Westcliff-On-Sea
State/Province
England
ZIP/Postal Code
SS0 0RY
Country
United Kingdom
Facility Name
Ninewells Hospital and Medical School
City
Dundee
State/Province
Scotland
ZIP/Postal Code
DD1 9SY
Country
United Kingdom
Facility Name
Edinburgh Cancer Centre at Western General Hospital
City
Edinburgh
State/Province
Scotland
ZIP/Postal Code
EH4 2XU
Country
United Kingdom
Facility Name
Western Infirmary
City
Glasgow
State/Province
Scotland
ZIP/Postal Code
G11 6NT
Country
United Kingdom
Facility Name
Raigmore Hospital
City
Inverness
State/Province
Scotland
ZIP/Postal Code
1V2 3UJ
Country
United Kingdom
Facility Name
Velindre Cancer Center at Velindre Hospital
City
Cardiff
State/Province
Wales
ZIP/Postal Code
CF14 2TL
Country
United Kingdom
Facility Name
Nevill Hall Hospital
City
Gwent
State/Province
Wales
Country
United Kingdom
Facility Name
Royal Gwent Hospital
City
Newport Gwent
State/Province
Wales
ZIP/Postal Code
NP9 2UB
Country
United Kingdom

12. IPD Sharing Statement

Citations:
PubMed Identifier
19047288
Citation
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. Erratum In: J Clin Oncol. 2009 Feb 20;27(6):1002.
Results Reference
result
Citation
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.
Results Reference
result
PubMed Identifier
17699816
Citation
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.
Results Reference
result
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.
Results Reference
result
PubMed Identifier
28027850
Citation
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.
Results Reference
derived
PubMed Identifier
18549175
Citation
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.
Results Reference
derived

Learn more about this trial

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

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