A Randomised Phase III Trial to Determine the Role of FDG-PET Imaging in Clinical Stages IA/IIA Hodgkin's Disease
- Determine whether patients with stage IA or IIA Hodgkin lymphoma who have a negative
fludeoxyglucose F 18 positron emission tomography (FDG-PET) imaging after 3 courses of
chemotherapy comprising doxorubicin hydrochloride, bleomycin sulfate, vinblastine, and
dacarbazine (ABVD) require consolidation radiotherapy (to areas of previous
involvement) in order to delay or prevent disease progression.
OUTLINE: Patients receive doxorubicin hydrochloride IV, bleomycin sulfate IV, vinblastine
IV, and dacarbazine IV (ABVD) on days 1 and 15. Treatment repeats every 28 days for 3
courses. On day 15 of the third course of chemotherapy, patients undergo a CT scan of the
neck, thorax, abdomen and pelvis. Patients with nonresponsive disease or progressive disease
are removed from the study. Patients who achieve response undergo fludeoxyglucose F 18
positron emission tomography (FDG-PET). Patients with a positive FDG-PET scan receive an
additional course of ABVD and undergo involved field radiotherapy. Patients with a negative
FDG-PET scan are randomized to 1 of 2 treatment arms.
- Arm I: Within 6 weeks after completion of course 3 of chemotherapy, patients undergo
involved field radiotherapy to disease areas.
- Arm II: Patients receive no further treatment. After completion of study therapy,
patients are followed up every 3 months for 1 year, every 4 months for 1 year, every 6
months for 1 year, and then annually thereafter.
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
up to 5 years after randomisation
John Radford, MD
Christie Hospital NHS Foundation Trust
United Kingdom: NHS Health Research Authority