| Source of record | Leukaemia Research Fund |
| ISRCTN | ISRCTN99811594 |
| Serial number at source | 99811594 |
| Other organisations' reference numbers | None |
| Title of trial/grant title | A randomised phase III trial to determine the role of fluorodeoxyglucose-positron-emission tomography (FDG-PET) imaging in clinical stages Ia/IIa Hodgkin's Disease |
| Acronym | FDG-PET |
| Disease or condition | Hodgkin's Disease |
| Current status of trial | Open |
| Patient information material | Patient information sheets can be obtained from:
Paul Mouncey
Clinical Trial Centre
University College London
Tel: +44 (0)20 7679 8060
Email: pm@ctc.ucl.ac.uk |
| Topic/hypothesis/clinical objectives | The aim of this trial is to determine whether patients with clinical stage IA/IIA Hodgkin’s disease who have a negative FDG-PET scan after 3 cycles of ABVD require consolidation radiotherapy to areas of previous involvement in order to delay or prevent disease progression. |
| Design/methodology | Randomised phase III trial |
| Eligibility criteria - inclusion | 1. Age 16-75 years
2. Histologically confirmed Hodgkin’s disease (histology will be reviewed retrospectively by Professor A Jack at the Haematological Malignancy Diagnostic Service in Leeds but please note that this is not required before trial entry)
3. Clinical stages IA/IIA above the diaphragm with no mediastinal bulk (defined as maximum transverse diameter of mediastinal mass: internal thoracic diameter at level of D5/6 interspace >0.33). Bulky disease at other sites (defined as nodal mass with transverse diameter >10 cm) is acceptable.
4. No previous treatment for Hodgkin’s disease
5. No previous malignancy excepting appropriately treated basal cell carcinoma of the skin or carcinoma in situ of the cervix
6. No contraindications to chemotherapy or radiotherapy
7. Patients with reproductive potential, a willingness to use contraception from entry into the study for a period of 6 months
8. Written informed consent |
| Eligibility criteria - exclusion | 1. Patients with clinical stage IA Hodgkin’s disease with no clinical or computed tomography (CT) evidence of disease after diagnostic biopsy
2. Pregnant or lactating women
3. Severe underlying illness considered likely to make the trial therapy hazardous (for example severe heart disease or lung fibrosis)
4. Patients unwilling to travel to the nearest PET Centre
5. Patients unable to comply with follow-up arrangements. |
| Randomised interventions | Patients with a negative PET scan after 3 cycles of ABVD will be randomised to involved field radiotherapy or no further treatment. |
| Sources of funding | Leukaemia Research Fund |
| Contact name(s) | Professor J A Radford |
| Contact details | Clinical Trial Centre
University College London
UK
Tel:+44 (0)20 7679 8060
Email: pm@ctc.ucl.ac.uk |
| Further information | This trial register was updated in October 2003. Further information can be obtained from the lead researcher named above, or from the National Cancer Research Network database. |
| Date live in mRCT | 03 August 2004 |
