Trial Information

A UKLG Randomised Trial of Initial Chemotherapy for Advanced Stage Hodgkins Disease

OBJECTIVES: I. Determine whether a four-drug anthracycline-based regimen or a seven-drug
hybrid or eight-drug alternating regimen is the optimal treatment for patients with advanced
Hodgkin's disease.

OUTLINE: This is a randomized study. Patients are randomized to one of two treatment arms.
Arm I (ABVD): Patients receive doxorubicin IV, bleomycin IV, vinblastine IV, and dacarbazine
IV on days 1 and 15. Courses repeat every 4 weeks. Arm II (ChlVPP/PABLOE): Patients receive
oral chlorambucil, procarbazine, and prednisolone on days 1-14; vinblastine IV on days 1 and
8; doxorubicin IV on day 29; vincristine IV and bleomycin IV on days 29 and 36; oral
etoposide on days 29-31; and oral prednisolone again on days 29-38. Courses repeat every 7
weeks. OR (Hybrid - ChlVPP/EVA): Patients receive vincristine IV on day 1; oral etoposide on
days 1-5; oral chlorambucil, procarbazine, and prednisolone on days 1-7; and doxorubicin IV
and vinblastine IV on day 8. Courses repeat every 4 weeks. Patients in both arms receive up
to 6-8 courses of treatment. Radiotherapy may be given to sites of previous bulk disease for
patients in complete remission or uncertain remission. Patients who achieve partial
remission may receive radiotherapy to residual disease sites. Patients who fail to respond,
or have disease progression, may receive induction therapy followed by high-dose
consolidation therapy. Patients are followed every 3 months for 2 years, every 6 months for
5 years, and then annually for 5 years.

PROJECTED ACCRUAL: Approximately 800 patients will be accrued for this study.