A comparison of hybrid chemotherapy versus hybrid chemotherapy and autotransplant in poor prognosis Hodgkin's disease
| ISRCTN | ISRCTN39498786 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN39498786 |
| Secondary identifying numbers | SNLG HDIII |
- Submission date
- 19/08/2002
- Registration date
- 19/08/2002
- Last edited
- 13/06/2014
- 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
Dr - -
Scientific
Scientific
UKCCCR Register Co-ordinator
MRC Clinical Trials Unit
222 Euston Road
London
NW1 2DA
United Kingdom
Study information
| 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 | |
| Study objectives | Not provided at time of registration |
| Ethics approval(s) | Not provided at time of registration |
| Health condition(s) or problem(s) studied | Lymphoma (Hodgkin's) |
| Intervention | All patients receive three 28-day cycles of PVACE-BOP (chlorambucil, procarbazine, etoposide, vinblastine, adriamycin, bleomycin and prednisolone), together with co-trimoxazole every 3 weeks for the duration of treatment. Patients who achieve at least a partial remission are randomised to one of two treatment regimens: 1. Regimen A: Radiotherapy, 30 Gy in 3 weeks to initially bulky sites or residual areas of disease, followed by two further cycles of PVACE-BOP 2. Regimen B: Radiotherapy, 30 Gy in 3 weeks to initially bulky sites or residual areas of disease, followed by intensive chemotherapy with melphan and etoposide plus autologous bone marrow transplantation. |
| Intervention type | Other |
| Primary outcome measure | Not provided at time of registration |
| Secondary outcome measures | Not provided at time of registration |
| Overall study start date | 01/01/2001 |
| Completion date | 31/12/2004 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | Both |
| Target number of participants | Not provided at time of registration |
| Key inclusion criteria | 1. Histological diagnosis of Hodgkin's disease 2. Prognostic index of at least 0.5 3. Aged under 60 4. No prior chemotherapy or radiotherapy 5. No known significant heart, lung or renal disease 6. No co-existing malignancies apart from localised skin lesions |
| Key exclusion criteria | Not provided at time of registration |
| Date of first enrolment | 01/01/2001 |
| Date of final enrolment | 31/12/2004 |
Locations
Countries of recruitment
- England
- United Kingdom
Study participating centre
UKCCCR Register Co-ordinator
London
NW1 2DA
United Kingdom
NW1 2DA
United Kingdom
Sponsor information
UK Co-ordinating Committee for Cancer Research (UKCCCR)
Government
Government
MRC Clinical Trials Unit
222 Euston Road
London
NW1 2DA
United Kingdom
"ROR" |
https://ror.org/054225q67 |
|---|
Funders
Funder type
Not defined
Not provided at time of registration
No information available
Results and Publications
| 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 |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | results | 01/04/2002 | Yes | No |
