*RADAR
Research type
Research Study
Full title
A randomised phase III trial with a PET response adapted design comparing ABVD +/- ISRT with A2VD +/- ISRT in patients with previously untreated stage IA/IIA Hodgkin lymphoma
IRAS ID
291267
Contact name
John Radford
Contact email
Sponsor organisation
University College London
Eudract number
2020-005160-65
Clinicaltrials.gov Identifier
Clinicaltrials.gov Identifier
119186, EDGE ID
Duration of Study in the UK
10 years, 6 months, 0 days
Research summary
The RADAR trial is a phase III trial investigating whether substituting brentuximab vedotin for bleomycin in standard chemotherapy for patients with previously untreated early stage Hodgkin Lymphoma (HL) can:
• Help stop the lymphoma from coming back
• Help more people reach a deep remission quickly
• Improve patient survival
• Cause less lung damage
• Reduce the need for radiotherapy, and the rates of radiotherapy-related toxicities such as second cancers and heart disease.The current standard treatment for patients with early stage HL is 3-4 cycles of ABVD chemotherapy (doxorubicin, bleomycin, vinblastine, dacarbazine), often followed by radiotherapy. Bleomycin can cause lung damage, so doctors are interested in finding alternative drugs that be used instead. Brentuximab vedotin (BV) is an ‘antibody-drug conjugate’: an antibody that attaches to cancer cells, then inserts a drug into the cells that causes them to die. BV has been tested in relapsed and advanced stage HL, and we now want to know if it can also be used for early stage disease, as an alternative to bleomycin.
Eligible patients will be randomised to have treatment with one of the following:
• ABVD (doxorubicin, bleomycin, vinblastine, dacarbazine; standard treatment)
• A2VD (doxorubicin, brentuximab vedotin, vinblastine, dacarbazine; experimental treatment)RADAR has a ‘PET response-adapted design’, meaning that the amount of treatment patients get will depend on their response to the first two cycles of treatment. Patients will have a PET-CT scan at the end of cycle 2, which will be centrally reviewed. Patients who have responded well will have one more cycle of ABVD/A2VD. Patients who have responded less well will have two more cycles of ABVD/A2VD followed by radiotherapy.
Patients will be followed up for at least 5 years after completing treatment.
Patients may take part in optional additional research: a PET-CT after 1 cycle and giving blood/tumour block samples for laboratory studies.
REC name
East of England - Essex Research Ethics Committee
REC reference
22/EE/0193
Date of REC Opinion
2 Aug 2021
REC opinion
Favourable Opinion