| Source of record | UK Clinical Trials Gateway |
| ISRCTN | ISRCTN39498786 |
| Date ISRCTN assigned | 19/08/2002 |
| Local reference number(s) | SNLG HDIII |
| Public title | A Comparison of Hybrid Chemotherapy versus Hybrid Chemotherapy and Autotransplant in Poor Prognosis Hodgkin's Disease |
| Scientific title |
|
| Acronym | N/A |
| Disease/condition/study domain | Lymphoma (Hodgkin's) |
| Study hypothesis | Not provided at time of registration |
| Design/methodology | Randomised controlled trial |
| Research ethics review | Not provided at time of registration |
| Countries of trial | United Kingdom |
| Participants - 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 |
| Participants - exclusion criteria | Not provided at time of registration |
| Patient information material |
|
| Status of trial | Completed |
| Target number of participants | Not provided at time of registration |
| Interventions | 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. |
| Primary outcome measure(s) | Not provided at time of registration |
| Secondary outcome measure(s) | Not provided at time of registration |
| Sources of funding | Not available |
| Sponsor name | UK Co-ordinating Committee for Cancer Research (UKCCCR) |
| Sponsor details | MRC Clinical Trials Unit
222 Euston Road
London
United Kingdom
NW1 2DA |
| Sponsor telephone | +44 (0) 20 7670 4723 |
| Sponsor fax | +44 (0) 20 7670 4818 |
| Sponsor email | register@ctu.mrc.ac.uk |
| Sponsor website | http://www.ctu.mrc.ac.uk/ukcccr/home.html |
| Contact name | Dr - - |
| Contact details | UKCCCR Register Co-ordinator
MRC Clinical Trials Unit
222 Euston Road
London
United Kingdom
NW1 2DA |
| Contact telephone | +44 (0) 20 7670 4723 |
| Contact fax | +44 (0) 20 7670 4818 |
| Contact email | register@ctu.mrc.ac.uk |
| More information | For more up-to-date information please go to the ISRCTN link below. |
| Link to record in ISRCTN Register | ISRCTN39498786 |
| Date last extracted from ISRCTN register | 17/04/2008 |
