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Main
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Note: This record shows only the 20 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ISRCTN |
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Last refreshed on:
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12 February 2013 |
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Main ID: |
ISRCTN26181691 |
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Date of registration:
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01/07/2001 |
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Primary sponsor: |
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Public title:
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Weekly intensive versus standard chemotherapy in untreated small cell lung cancer (SCLC) patients with good prognosis
N/A |
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Scientific title:
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Date of first enrolment:
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Jan 1 1988 |
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Target sample size:
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Not provided at time of registration |
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Recruitment status: |
Completed/Not recruiting |
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URL:
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http://isrctn.org/ISRCTN26181691 |
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Study type:
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Interventional |
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Study design:
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Randomised controlled trial
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Countries of recruitment
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United Kingdom
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Contacts
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Name:
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Address:
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UKCCCR Register Co-ordinator
MRC Clinical Trials Unit
222 Euston Road
NW1 2DA
London
United Kingdom |
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Telephone:
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+44 (0) 207 670 4723 |
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Email:
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Affiliation:
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Key inclusion & exclusion criteria
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Inclusion criteria: 1. Histologically or cytologically proven SCLC
2. Age 75 or under
3. Either limited disease or extensive disease in the good prognostic category. That is have both of the following characteristics, Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1 and alkaline phosphatase <1.5 upper limit of normal range
4. Adequate renal function
5. No previous malignancy, except non-melanomatous skin cancer
6. No previous chemotherapy or radiotherapy
7. No medical contraindications to treatment
Exclusion criteria: Not provided at time of registration
Age minimum:
Age maximum:
Gender:
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Health Condition(s) or Problem(s) studied
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Lung (small cell)
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Intervention(s)
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1. Intensive Regimen: Chemotherapy, cisplatin and etoposide alternating every 7 days with ifosfamide and adriamycin. A total of twelve courses, six with each drug combination.
2. Standard Regimen: Chemotherapy, cisplatin and etoposide alternating every 21 days with ifosfamide and adriamycin. A total of six courses, three with each drug combination.
All limited disease patients who show complete or partial response following chemotherapy receive thoracic irradiation.
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Primary Outcome(s)
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Not provided at time of registration
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Secondary Outcome(s)
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Not provided at time of registration
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Source(s) of Monetary Support
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Cancer Research UK
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