Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
TR6SCLC
Study information
Scientific title
Weekly intensive versus standard chemotherapy in untreated small cell lung cancer (SCLC) patients with good prognosis
Acronym
Study hypothesis
Not provided at time of registration
Ethics approval
Not provided at time of registration
Study design
Randomised controlled trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Hospitals
Trial type
Treatment
Patient information sheet
Condition
Lung (small cell) cancer
Intervention
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.
Intervention type
Drug
Phase
Not Applicable
Drug names
Cisplatin, etoposide, ifosfamide, adriamycin
Primary outcome measures
Not provided at time of registration
Secondary outcome measures
Not provided at time of registration
Overall trial start date
01/01/1988
Overall trial end date
31/12/1992
Reason abandoned
Eligibility
Participant 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
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
Not provided at time of registration
Participant exclusion criteria
Not provided at time of registration
Recruitment start date
01/01/1988
Recruitment end date
31/12/1992
Locations
Countries of recruitment
United Kingdom
Trial participating centre
MRC Clinical Trials Unit
London
NW1 2DA
United Kingdom
Sponsor information
Organisation
Cancer Research UK (CRUK) (UK)
Sponsor details
PO Box 123
Lincoln's Inn Fields
London
WC2A 3PX
United Kingdom
+44 (0)207 317 5186
kate.law@cancer.org.uk
Sponsor type
Charity
Website
Funders
Funder type
Charity
Funder name
Cancer Research UK
Alternative name(s)
Funding Body Type
private sector organisation
Funding Body Subtype
other non-profit
Location
United Kingdom
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Results - basic reporting
Publication summary