To evaluate whether chemotherapy alone is as effective -but less toxic-, as combined modality treatment in terms of progression-free survival (PFS), in patients with stages I/II Hodgkin*s lymphoma who are FDG-PET scan negative after two cycles of…
ID
Source
Brief title
Condition
- Lymphomas Hodgkin's disease
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
To find out whether investigational treatments (without radiotherapy) are non
inferior to the standard treatments in patients with a negative PET scan after 2
cycles of ABVD. This will be separately evaluated in patients with an initially
favorable prognosis (Group A), and in patients with an initially unfavorable
prognosis (Group B).
With a standard 5 years progression free survival of 95% and 85% in the
experimental arm (non radiotherapy and expectance of 10 -15% less long term
toxicity) 608 patients will be needed in the F and 720 in the U group
In PET positive patients, the objective is to find out whether progression free
survival can be improved by treatment intensification (investigational
treatment) as compared to standard therapy. The favorable and unfavorable
patients will be grouped for this analysis (group C). A total of 248 will be
simultaneously accrued in group C (55/year). At the time of the final analysis,
77 events will be recorded in those patients. The final analysis will provide a
77% power to detect a 20% improvement (from 50% to 70%) in 5 years progression
free survival rate with the investigational arm.
Secondary outcome
Not applicable
Background summary
The H10-trial aims at reducing toxicity while maintaining efficacy in patients
with early stage HL who experience an excellent tumor-free outcome with
standard combined modality treatment. However, the long-term serious adverse
events of treatment ask for modification of primary treatment burden. This
randomized phase III trial aims at identifying the group of patients that will
enjoy long-term tumor free survival with less intensive treatment and thus
-according to our hypothesis- less serious long-term adverse events. The
identification of the *good-risk*-group will be based upon the early response
to ABVD (after two cycles) analyzed by FDG-PET scan. When according to FDG-PET
scanning no viable tumor is left after two cycles of ABVD (both in the abinitio
favorable (F) as well as unfavorable subgroup (U)), we will withhold RT for
these patients and complete the treatment with chemotherapy alone whereas the
patients in the standard combined modality arm will receive additional cycles
of ABVD + involved node RT (IN-RT) irrespective of the result of the FDG-PET
scan. Notably, in the standard arm FDG-PET scan after 2 cycles of ABVD is
mandatory as well, but the result will be used for documentation purposes only.
When according to FDG-PET scanning viable tumor is still present after two
cycles of ABVD (both in the ab initio favorable (F) as well as unfavorable
subgroup (U)), we will change chemotherapy from
ABVD to a more intense schedule e.g. escalated BEACOPP for two cycles followed
by IN-RT. By doing this we are aiming at improving the PFS for this subgroup of
patients whereas the patients in the standard combined modality arm will
receive additional cycles of ABVD + IN-RT.
Study objective
To evaluate whether chemotherapy alone is as effective -but less toxic-, as
combined modality treatment in terms of progression-free survival (PFS), in
patients with stages I/II Hodgkin*s lymphoma who are FDG-PET scan negative
after two cycles of ABVD. This question will be addressed in the group of
patients with favorable stages I/II disease as well as in those with
unfavorable stages I/II disease.
Evaluate whether early change of chemotherapy from ABVD to escalated BEACOPP
improves the progression-free survival of patients who are FDG-PET-positive
after two cycles of ABVD, as compared with those who continue on standard ABVD
in both favorable as well as unfavorable subsets of patients.
Confirm that early response to FDG-PET scan can predict the outcome of patients
with stage I/II Hodgkin*s lymphoma. This will be evaluated in the patients
randomized in the standard arm.
Study design
Fase III, randomized, open, multicenter intergroup trial
Intervention
ABVD and FDG-PET followed by ABVD or escalated BEACOPPin combination with
radiotherapy depending on the outcome of the FDG-PET.
Study burden and risks
FDG-PET
Avenue E. Mounierlaan 83/11
Brussel 1200
BE
Avenue E. Mounierlaan 83/11
Brussel 1200
BE
Listed location countries
Age
Inclusion criteria
Histologically confirmed Hodgkin's lymphoma (HL), except for nodular
lymphocyte predominant subtype (nodular paragranuloma)
Supradiaphragmatic Ann Arbor clinical stage I or II
Previously untreated
Clinical stages I/II
Age 15-70 years
WHO performance 0-3
FDG-PET scan prospectively planned after two cycles of ABVD in all
patients
Informed consent
Exclusion criteria
No FDG-Pet scan facilities available
Inadequate liver-renal function (bili>2,5x uln or creat >2,5x uln
Unstable diabetes mellitus (because of FDG-PET scan
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| EudraCT | EUCTR2005-002765-37-NL |
| CCMO | NL12065.091.06 |