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 (NCT) | NCT00002987 |
| Protocol serial number | LY07 |
| Sponsor | Cancer Research UK (CRUK) (UK) |
| Funder | Cancer Research UK |
- Submission date
- 01/07/2001
- Registration date
- 01/07/2001
- Last edited
- 17/02/2015
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Cancer
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Plain English summary of protocol
Not provided at time of registration
Contact information
- -
Scientific
Scientific
UKCCCR Register Co-ordinator
MRC Clinical Trials Unit
222 Euston Road
London
NW1 2DA
United Kingdom
Study information
| Primary study design | Interventional |
|---|---|
| Study design | Randomised controlled trial |
| Secondary study design | Randomised controlled trial |
| Study type | Participant 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 |
| Phase | Not Applicable |
| Drug / device / biological / vaccine name(s) | Vincristine, adriamycin, etoposide, cyclophosphamide and bleomycin |
| Primary outcome measure(s) |
Not provided at time of registration |
| Key secondary outcome measure(s) |
Not provided at time of registration |
| Completion date | 26/06/2001 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | All |
| 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 |
Locations
Countries of recruitment
- United Kingdom
Study participating centre
-
Results and Publications
| Individual participant data (IPD) Intention to share | No |
|---|---|
| IPD sharing plan summary | |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Abstract results | abstract A-E08, 39 | 07/09/2004 | No | No | |
| Participant information sheet | Participant information sheet | 11/11/2025 | 11/11/2025 | No | Yes |
