Radiation Therapy to Prevent Brain Metastases in Patients With Previously Treated Extensive-Stage Small Cell Lung Cancer
Study Details
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 3 |
Detailed Description
OBJECTIVES:
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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.
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Compare the quality of life and survival of these patients.
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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.
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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.
Study Design
Outcome Measures
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 []
Eligibility Criteria
Criteria
DISEASE CHARACTERISTICS:
-
Cytologically or histologically confirmed small cell lung cancer
-
Documented extensive disease before the initiation of chemotherapy
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Responsive disease after 4 to 6 courses of initial chemotherapy
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No more than 5 weeks since completion of prior chemotherapy
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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
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Ziekenhuis Netwerk Antwerpen Middelheim | Antwerp | Belgium | 2020 | |
| 2 | Universiteit Gent | Ghent | Belgium | B-9000 | |
| 3 | Hopital de Jolimont | Haine Saint Paul | Belgium | 7100 | |
| 4 | Cazk Groeninghe - Campus Maria's Voorzienigheid | Kortrijk | Belgium | B-8500 | |
| 5 | Centre Hospitalier Regional de la Citadelle | Liege | Belgium | 4000 | |
| 6 | Clinique Saint-Joseph | Liege | Belgium | B 4000 | |
| 7 | Bank Of Cyprus Oncology Centre | Nicosia | Cyprus | 2006 Strovolos | |
| 8 | National Cancer Institute of Egypt | Cairo | Egypt | ||
| 9 | Institut Gustave Roussy | Villejuif | France | F-94805 | |
| 10 | Universitaetsklinikum Hamburg-Eppendorf | Hamburg | Germany | D-20246 | |
| 11 | University of Kaposvar | Kaposvar | Hungary | 7400 | |
| 12 | Rambam Medical Center | Haifa | Israel | 31096 | |
| 13 | Ospedale Santa Croce | Cuneo | Italy | 12100 | |
| 14 | Istituto Nazionale per la Ricerca sul Cancro | Genoa (Genova) | Italy | 16132 | |
| 15 | Azienda Ospedaliera Di Parma | Parma | Italy | 43100 | |
| 16 | Vrije Universiteit Medisch Centrum | Amsterdam | Netherlands | 1001HV | |
| 17 | Academisch Medisch Centrum at University of Amsterdam | Amsterdam | Netherlands | 1105 AZ | |
| 18 | Arnhems Radiotherapeutisch Instituut | Arnhem | Netherlands | 6815 AD | |
| 19 | Radiotherapeutisch Instituut-(Riso) | Deventer | Netherlands | 7400 AC | |
| 20 | University Medical Center Groningen | Groningen | Netherlands | 9700 RB | |
| 21 | Radiotherapeutisch Instituut Friesland | Leeuwarden | Netherlands | 8934 AD | |
| 22 | Leiden University Medical Center | Leiden | Netherlands | 2300 CA | |
| 23 | Nijmegen Cancer Center at Radboud University Medical Center | Nijmegen | Netherlands | NL-6500 HB | |
| 24 | University Medical Center Rotterdam at Erasmus Medical Center | Rotterdam | Netherlands | 3000 CA | |
| 25 | Erasmus MC - Sophia Children's Hospital | Rotterdam | Netherlands | 3015 GJ | |
| 26 | Dr. Bernard Verbeeten Instituut | Tilburg | Netherlands | 5042 SB | |
| 27 | Medical University of Gdansk | Gdansk | Poland | 80-211 | |
| 28 | Marmara University Hospital | Istanbul | Turkey | 81190 | |
| 29 | Bristol Haematology and Oncology Centre | Bristol | England | United Kingdom | BS2 8ED |
| 30 | Princess Royal Hospital | Hull | England | United Kingdom | HU8 9HE |
| 31 | Cookridge Hospital at Leeds Teaching Hospital NHS Trust | Leeds | England | United Kingdom | LS16 6QB |
| 32 | Leicester Royal Infirmary | Leicester | England | United Kingdom | LE1 5WW |
| 33 | Christie Hospital N.H.S. Trust | Manchester | England | United Kingdom | M20 4BX |
| 34 | Clatterbridge Centre for Oncology NHS Trust | Merseyside | England | United Kingdom | CH63 4JY |
| 35 | Northern Centre for Cancer Treatment at Newcastle General Hospital | Newcastle Upon Tyne | England | United Kingdom | NE4 6BE |
| 36 | Mount Vernon Cancer Centre at Mount Vernon Hospital | Northwood | England | United Kingdom | HA6 2RN |
| 37 | Nottingham City Hospital NHS Trust | Nottingham | England | United Kingdom | NG5 1PB |
| 38 | Cancer Research Centre at Weston Park Hospital | Sheffield | England | United Kingdom | S1O 2SJ |
| 39 | Royal Shrewsbury Hospital | Shrewsbury | England | United Kingdom | SY3 8XQ |
| 40 | Southampton General Hospital | Southampton | England | United Kingdom | SO16 6YD |
| 41 | Royal Marsden NHS Foundation Trust - Surrey | Sutton | England | United Kingdom | SM2 5PT |
| 42 | Southend NHS Trust Hospital | Westcliff-On-Sea | England | United Kingdom | SS0 0RY |
| 43 | Ninewells Hospital and Medical School | Dundee | Scotland | United Kingdom | DD1 9SY |
| 44 | Edinburgh Cancer Centre at Western General Hospital | Edinburgh | Scotland | United Kingdom | EH4 2XU |
| 45 | Western Infirmary | Glasgow | Scotland | United Kingdom | G11 6NT |
| 46 | Raigmore Hospital | Inverness | Scotland | United Kingdom | 1V2 3UJ |
| 47 | Velindre Cancer Center at Velindre Hospital | Cardiff | Wales | United Kingdom | CF14 2TL |
| 48 | Nevill Hall Hospital | Gwent | Wales | United Kingdom | |
| 49 | Royal Gwent Hospital | Newport Gwent | Wales | United Kingdom | NP9 2UB |
Sponsors and Collaborators
- European Organisation for Research and Treatment of Cancer - EORTC
Investigators
- Study Chair: B.J. Slotman, PhD, MD, Free University Medical Center
- Study Chair: Pieter E. Postmus, MD, Free University Medical Center
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- EORTC-22993-08993
- EORTC-RA-22993
- EORTC-LCG-08993