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.
Long term follow-up using digital linkage of patients participating in the RAPID trial: Patient notification - November 2023
Since the publication of initial results of the RAPID trial in 2015 a further 8 years has elapsed and we want to know if survival still remains the same in both arms of the trial. We’d also like to find out if there’s any difference in the incidence of second cancers and heart disease between patients receiving chemotherapy alone and those receiving chemotherapy plus radiotherapy. This is important for future patients and their doctors as they make decisions about treatment.
Follow-up information is usually provided by the hospital where treatment was given but in most cases patients participating in the RAPID trial have now been discharged. For this reason we asked the Confidentiality Advisory Group (GAG) for permission to obtain follow-up information through a linkage with NHS England and the National Institute for Cardiovascular Outcomes Research (NICOR). This linkage has been allowed by CAG using the provisions of Section 251 but RAPID trial participants may opt-out of this mode of follow-up by contacting the Christie NHS Foundation Trust (trial sponsor) sponsorship team (the-christie.sponsoredresearch at nhs.net).
Professor John Radford, Chief Investigator of RAPID trial
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.