A Randomized Phase III Trial to Assess Response Adapted Therapy Using FDG-PET Imaging in Patients With Newly Diagnosed, Advanced Hodgkin Lymphoma
OBJECTIVES:
- To determine if fludeoxyglucose F 18 (FDG)-PET/CT imaging can be reproducibly and
effectively applied in the early assessment of response to chemotherapy in patients
with newly diagnosed stage II-IV Hodgkin lymphoma.
- To determine if a negative FDG-PET/CT scan after 2 courses of ABVD chemotherapy
comprising doxorubicin hydrochloride, bleomycin, vinblastine, and dacarbazine can be
used to predict a group of patients for whom it is safe to reduce therapy by the
subsequent omission of bleomycin, without detriment to progression-free survival.
- To determine if treatment intensification in response to positive FDG-PET/CT imaging
after 2 courses of ABVD chemotherapy can improve the outcome by comparison with
previous series.
OUTLINE: This is a multicenter study.
Patients undergo fludeoxyglucose F 18 (FDG)-PET/CT imaging at baseline. Patients then
receive ABVD chemotherapy comprising doxorubicin hydrochloride IV, bleomycin IV, vinblastine
IV, and dacarbazine IV on days 1 and 15. Treatment repeats every 28 days for up to 2 courses
in the absence of disease progression or unacceptable toxicity. Between days 22 and 25 of
course 2, patients undergo a second FDG-PET/CT scan to assess response. Subsequent therapy
is based on FDG-PET/CT scan results.
- Negative FDG-PET/CT scan: Patients with a negative FDG-PET/CT scan are randomized to 1
of 2 treatment arms.
- Arm I (ABVD chemotherapy): Patients receive ABVD chemotherapy comprising
doxorubicin hydrochloride IV, bleomycin IV, vinblastine IV, and dacarbazine IV on
days 1 and 15. Treatment repeats every 28 days for up to 4 courses in the absence
of disease progression or unacceptable toxicity.
- Arm II (AVD chemotherapy): Patients receive AVD chemotherapy comprising
doxorubicin hydrochloride IV, vinblastine IV, and dacarbazine IV on days 1 and 15.
Treatment repeats every 28 days for up to 4 courses in the absence of disease
progression or unacceptable toxicity.
- Positive FDG-PET/CT scan: Patients with a positive FDG-PET/CT scan are assigned to 1 of
2 chemotherapy regimens, as determined by the participating center.
- BEACOPP-14 chemotherapy: Patients receive doxorubicin hydrochloride IV and
cyclophosphamide IV on day 1; etoposide IV on days 1-3; oral procarbazine
hydrochloride and oral prednisolone on days 1-7; and bleomycin IV and vincristine
IV on day 8. Patients also receive filgrastim (G-CSF) subcutaneously (SC) on days
8-13 OR pegfilgrastim SC once on day 8. Treatment repeats every 14 days for up to
4 courses in the absence of disease progression or unacceptable toxicity.
- BEACOPP-escalated chemotherapy: Patients receive doxorubicin hydrochloride IV and
cyclophosphamide IV on day 1; etoposide IV on days 1-3; oral procarbazine
hydrochloride on days 1-7; oral prednisolone on days 1-14; and bleomycin IV and
vincristine IV on day 8. Patients also receive G-CSF SC beginning on day 8 and
continuing until blood counts recover OR pegfilgrastim SC once on day 8. Treatment
repeats every 21 days for up to 3 courses in the absence of disease progression or
unacceptable toxicity.
After completion of BEACOPP chemotherapy, patients undergo a third FDG-PET/CT scan to assess
response. Patients with a negative FDG-PET/CT scan receive 2 more courses of BEACOPP-14 or 1
more course of BEACOPP-escalated chemotherapy. Patients with a persistently positive
FDG-PET/CT scan may receive radiotherapy to sites of FDG uptake or salvage chemotherapy, at
the investigator's discretion.
After completion of study therapy, patients are followed every 3 months for 1 year, every 4
months for 2 years, every 6 months for 2 years, and then annually thereafter.
Peer Reviewed and Funded or Endorsed by Cancer Research UK.
Interventional
Allocation: Randomized, Masking: Open Label, Primary Purpose: Treatment
3-year progression-free survival
No
Peter Johnson, MD
Principal Investigator
University Hospital Southampton NHS Foundation Trust.
Unspecified
CDR0000593562
NCT00678327
August 2008
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