A multicentre randomised trial of short neo-adjuvant chemotherapy (VAPEC-B) plus involved field radiotherapy (MIT) versus mantle radiotherapy

ISRCTN	ISRCTN56416473
DOI	https://doi.org/10.1186/ISRCTN56416473
ClinicalTrials.gov number	NCT00002987
Secondary identifying numbers	LY07

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English summary of protocol

Not provided at time of registration

- - -
Scientific

UKCCCR Register Co-ordinator
MRC Clinical Trials Unit
222 Euston Road
London
NW1 2DA
United Kingdom

Study design	Randomised controlled trial
Primary study design	Interventional
Secondary study design	Randomised controlled trial
Study setting(s)	Hospital
Study type	Treatment
Participant information sheet	Not available in web format, please use the contact details below to request a patient information sheet
Scientific title	A multicentre randomised trial of short neo-adjuvant chemotherapy (VAPEC-B) plus involved field radiotherapy (MIT) versus mantle radiotherapy
Study objectives	Not provided at time of registration
Ethics approval(s)	Not provided at time of registration
Health condition(s) or problem(s) studied	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
Pharmaceutical study type(s)
Phase	Not Applicable
Drug / device / biological / vaccine name(s)	Vincristine, adriamycin, etoposide, cyclophosphamide and bleomycin
Primary outcome measure	Not provided at time of registration
Secondary outcome measures	Not provided at time of registration
Overall study start date	01/01/1995
Completion date	26/06/2001

Participant type(s)	Patient
Age group	Adult
Sex	Both
Target number of participants	Not provided at time of registration
Key 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)
Key exclusion criteria	If Hodgkin's disease is below the diaphragm only, patients are not eligible for this trial
Date of first enrolment	01/01/1995
Date of final enrolment	26/06/2001

Cancer Research UK (CRUK) (UK)
Charity

PO Box 123
Lincoln's Inn Fields
London
WC2A 3PX
United Kingdom

Charity

Cancer Research UK
Private sector organisation / Other non-profit organizations

Intention to publish date
Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
Publication and dissemination plan	Not provided at time of registration
IPD sharing plan

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Abstract results	abstract A-E08, 39	07/09/2004		No	No