Additional identifiers
EudraCT number
ClinicalTrials.gov number
NCT00002987
Protocol/serial number
LY07
Study information
Scientific title
A multicentre randomised trial of short neo-adjuvant chemotherapy (VAPEC-B) plus involved field radiotherapy (MIT) versus mantle radiotherapy
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
Not available in web format, please use the contact details below to request a patient information sheet
Condition
Lung (non-small cell) cancer
Intervention
1. VAPEC-B regimen: minimal initial chemotherapy therapy involving vincristine, adriamycin, etoposide, cyclophosphamide and bleomycin, followed by involved field radiotherapy
2. Control regimen: mantle radiotherapy
Intervention type
Drug
Phase
Not Applicable
Drug names
Vincristine, adriamycin, etoposide, cyclophosphamide and bleomycin
Primary outcome measures
Not provided at time of registration
Secondary outcome measures
Not provided at time of registration
Overall trial start date
01/01/1995
Overall trial end date
26/06/2001
Reason abandoned
Eligibility
Participant inclusion criteria
1. Patients aged between 16 and 75 years
2. Histologically proven Hodgkin's disease, stage IA or IIA with no mediastinal bulk
3. No previous treatment
4. No previous malignancy other than basal cell carcinoma or cervical intra-epithelial neoplasms
5. No concurrent illness which would contraindicate chemotherapy or radiotherapy
6. Not documented evidence of Human Immunodeficiency Virus (HIV) or Acquired Immunodeficiency Syndrome (AIDS)
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
Not provided at time of registration
Participant exclusion criteria
If Hodgkin's disease is below the diaphragm only, patients are not eligible for this trial
Recruitment start date
01/01/1995
Recruitment end date
26/06/2001
Locations
Countries of recruitment
United Kingdom
Trial participating centre
-
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)
CRUK
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
2004 results in:
Radford JA, Williams MV, Hancock BW, et al.: Minimal initial chemotherapy plus involved field radiotherapy (RT) vs. mantle field RT for clinical stage IA/IIA supra-diaphragmatic Hodgkin's disease (HD). Results of the UK Lymphoma Group LY07 trial. [Abstract] Eur J Haematol 73 (Suppl 65): A-E08, 39, 2004.
Publication citations
-
Results
Radford JA, Williams MV, Hancock BW, et al., Minimal initial chemotherapy plus involved field radiotherapy (RT) vs. mantle field RT for clinical stage IA/IIA supra-diaphragmatic Hodgkin's disease (HD) [Abstract] , Eur J Haematol, 2004, 73 , Suppl 65, A-E08, 39.