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Home > "R" Clinical Trials Conditions > Radiation Therapy to Prevent Brain Metastases in Patients With Previously Treated Extensive-Stage Small Cell Lung Cancer

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



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

For Condition: extensive stage small cell lung cancer
Status: Recruiting
Sponsor(s): EORTC Radiotherapy Cooperative Group , EORTC Lung Cancer Cooperative Group
Synopsis: 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: Randomizedphase 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.
Details: 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:
Study Type:
  Interventional, Treatment
Minimum Age/Maximum Age: 18 Years/75 Years
Genders: Both
Protocol Entry 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
Total Enrollment: 

Location and Contact Information:

Overall Study Official:
B.J.Slotman,  ,  Vrije Universiteit Medisch Centrum

Ninewells Hospital and Medical School *Recruiting*
Dundee,  Scotland,  DD1 9SY
United Kingdom
Recruiting Contact  Person 44-1382-66-0111

Hopital de Jolimont *Recruiting*
Haine-Saint-Paul,  ,  7100
Belgium
Recruiting Contact  Person 32-64-23-3011

National Cancer Institute of Egypt *Recruiting*
Cairo,  , 
Egypt
Recruiting Contact  Person 20-2-364-3661

Dokuz Eylul University School of Medicine *Recruiting*
Izmir,  ,  35340
Turkey
Recruiting Contact  Person 90-232-259-8773

Northern Centre for Cancer Treatment at Newcastle General Hospital *Recruiting*
Newcastle upon Tyne,  England,  NE4 6BE
United Kingdom
Recruiting Contact  Person 44-191-273-8811

Radiotherapeutisch Instituut-(Riso) *Recruiting*
Deventer,  ,  7400 AC
Netherlands
Recruiting Contact  Person 31-570-64-6900

Weston Park Hospital *Recruiting*
Sheffield,  England,  S1O 2SJ
United Kingdom
Recruiting Contact  Person 44-226-5000

Algemeen Ziekenhuis Middelheim *Recruiting*
Antwerp,  ,  2020
Belgium
Recruiting Contact  Person 32-3-280-3111

Dr. Bernard Verbeeten Instituut *Recruiting*
Tilburg,  ,  5042 SB
Netherlands
Recruiting Contact  Person 31-13-594-7777

Vrije Universiteit Medisch Centrum *Recruiting*
Amsterdam,  ,  1001HV
Netherlands
Recruiting Contact  Person 31-444-4444

Rambam Medical Center *Recruiting*
Haifa,  ,  31096
Israel
Recruiting Contact  Person 972-4-854-3013

Radiotherapeutisch Instituut Limburg-Maastricht *Recruiting*
Maastricht,  ,  NL-6229 ET
Netherlands
Recruiting Contact  Person 31-45-455-771-200

Nottingham City Hospital NHS Trust *Recruiting*
Nottingham,  England,  NG5 1PB
United Kingdom
Recruiting Contact  Person 44-115-969-1169

Isala Klinieken - locatie Sophia *Recruiting*
Zwolle,  ,  8000 GK
Netherlands
Recruiting Contact  Person 31-38-424-5000

University Medical Center Nijmegen *Recruiting*
Nijmegen,  ,  NL-6500 HB
Netherlands
Recruiting Contact  Person 31-24-361-1111

Centre Hospitalier Regional de la Citadelle *Recruiting*
LIEGE,  ,  4000
Belgium
Recruiting Contact  Person 32-42-225-6111

Western General Hospital *Recruiting*
Edinburgh,  Scotland,  EH4 2XU
United Kingdom
Recruiting Contact  Person 44-131-777-3500

Istituto Nazionale per la Ricerca sul Cancro *Recruiting*
Genoa (Genova),  ,  16132
Italy
Recruiting Contact  Person 39-10-560-0848

Charite - Universitaetsmedizin Berlin *Recruiting*
Berlin,  ,  D-12200
Germany
Recruiting Contact  Person 030-8445-0

University of Kaposvar *Recruiting*
Kaposvar,  ,  7400
Hungary
Recruiting Contact  Person 36-82-502-000

Bank Of Cyprus Oncology Centre *Recruiting*
Nicosia,  ,  2006 Strovolos
Cyprus
Recruiting Contact  Person 90-357-84-1300

Ospedale Santa Croce *Recruiting*
Cuneo,  ,  12100
Italy
Recruiting Contact  Person 39-171-4411

Daniel Den Hoed Cancer Center at Erasmus Medical Center *Recruiting*
Rotterdam,  ,  3008 AE
Netherlands
Recruiting Contact  Perosn 31-10-439-1911

Marmara University Hospital *Recruiting*
Istanbul,  ,  81190
Turkey
Recruiting Contact  Person 90-216-327-5050

Southend NHS Trust Hospital *Recruiting*
Westcliff-On-Sea,  England,  SS0 0RY
United Kingdom
Recruiting Contact  Person 44-1702-43-5555

Medical University of Gdansk *Recruiting*
Gdansk,  ,  80-211
Poland
Recruiting Contact  Person 48-58-349-2222

Mount Vernon Hospital *Recruiting*
Northwood,  England,  HA6 2RN
United Kingdom
Recruiting Contact  Person 44-1923-82-6111

Leiden University Medical Center *Recruiting*
Leiden,  ,  2300 CA
Netherlands
Recruiting Contact  Person 31-71-52-6911

Velindre Cancer Center at Velinde Hospital *Recruiting*
Cardiff,  Wales,  CF14 2TL
United Kingdom
Recruiting Contact  Person 44-29-2061-5888

Academisch Medisch Centrum *Recruiting*
Amsterdam,  ,  1105 AZ
Netherlands
Recruiting Contact  Person 31-20-566-9111

Arnhems Radiotherapeutisch Instituut *Recruiting*
ARNHEM,  ,  6815 AD
Netherlands
Recruiting Contact  Person 31-26-371-2470


Additional Information:
Study ID Numbers:
  CDR0000068607;  EORTC-LCG-08993,EORTC-RA-22993
Study Start Date: 
Record last reviewed: July 2003
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00016211

Other Extensive Stage Small Cell Lung Cancer Studies:
1. Cisplatin, Etoposide, and Cyclophosphamide in Treating Patients With Extensive-Stage Small Cell Lung Cancer

2. Radiation Therapy in Preventing Brain Metastases in Patients With Small Cell Lung Cancer

3. Combination Chemotherapy in Treating Patients With Extensive-Stage Small Cell Lung Cancer

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

5. Phase I/II Study of Lepirudin in Patients with Recurrent or Extensive Stage Small Cell Lung Cancer

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

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