A Randomised Phase III Trial to Determine the Role of FDG-PET Imaging in Clinical Stages IA/IIA Hodgkin’s Disease
Description
Design:
A randomised (1:1), multicentre, phase III trial 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.
Treatment:
Patients with early stage, low risk Hodgkin’s disease will receive 3 cycles of ABVD chemotherapy followed by FDG-PET imaging. Individuals who are PET positive will receive a further (4th) cycle of ABVD followed by involved field radiotherapy. Those who are PET negative will be randomised to receive either involved field RT or no further treatment. All patients will then be followed up uniformly with surveillance CT scans at 6, 12 and 24 months.
Key inclusion/exclusion criteria:
Inclusion criteria
- Age 16-75 years
- Histologically confirmed Hodgkin’s disease
- 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.
- No previous treatment for Hodgkin’s disease
- No previous malignancy (with exceptions)
- No contraindications to chemotherapy or radiotherapy
Exclusion criteria
- Patients with clinical stage IA Hodgkin’s disease with no clinical or CT evidence of disease after diagnostic biopsy
- Pregnant or lactating women
- Severe underlying illness considered likely to make the trial therapy hazardous
Duration of recruitment:
7 years
Aim
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.