Clinical Trial Details
— Status: Completed
Administrative data
| NCT number |
NCT00678327 |
| Other study ID # |
CDR0000593562 |
| Secondary ID |
CRUK-2007-006064 |
| Status |
Completed |
| Phase |
Phase 3
|
| First received |
|
| Last updated |
|
| Start date |
August 29, 2008 |
| Est. completion date |
May 1, 2024 |
Study information
| Verified date |
May 2024 |
| Source |
University College, London |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial Summary
RATIONALE: Imaging procedures, such as fludeoxyglucose F 18 (FDG)-PET/CT scan, done before,
during, and after chemotherapy may help doctors assess a patient's response to treatment and
help plan the best treatment. It is not yet known whether FDG-PET/CT imaging is effective in
assessing response to chemotherapy in patients with newly diagnosed Hodgkin lymphoma.
PURPOSE: This randomized phase III trial is studying FDG-PET/CT imaging to see how well it
works in assessing response to chemotherapy in patients with newly diagnosed stage II, stage
III, or stage IV Hodgkin lymphoma.
Description:
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.
