RAPID (PET)
Trial overview
A randomised phase III trial to determine the role of FDG-P imaging in clinical stages IA/IIA Hodgkins disease.
Inclusion criteria
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
Exclusion criteria
1] Patients with clinical stage IA Hodgkin’s disease with no clinical or 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 as defined in section 14 of this protocol.
Contact details
Other trials currently active for Classical Hodgkin Lymphoma
A RANDOMISED PHASE III TRIAL TO
ASSESS RESPONSE ADAPTED
THERAPY USING FDG-PET IMAGING
IN PATIENTS WITH NEWLY
DIAGNOSED, ADVANCED HODGKIN
LYMPHOMA
A randomized, doubleblind, placebo controlled Phase 3 study of SGN35 (brentuximab vedotin) and best supportive care versus placebo and best supportive care in the treatment of patients at high risk of residual Hodgkin lymphoma following autologous stem cell transplant.
An open-label, multicenter, phase 2/3 clinical trial designed to provide the option of treatment with brentuximab vedotin (SGN-35) for patients who were allocated to the placebo treatment arm in the Phase 3 study SGN35-005 and experienced progression of HL during the study.