The aim of this study is to reduce the indication for RT without compromising cure rates. To investigate if intensified consolidation therapy (DECOPDAC-21) compared to standard consolidation therapy (COPDAC-28) can compensate for reduction in RT.
ID
Source
Brief title
Condition
- Lymphomas Hodgkin's disease
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
- To increase event-free survival (EFS) in ERA PET-negative TL-2 and TL-3
patients without radiotherapy by using intensified consolidation chemotherapy
(DECOPDAC-21).
- To demonstrate in ERA PET-positive TL-2 and TL-3 patients that the
combination of intensified consolidation chemotherapy (DECOPDAC-21) plus
restricted field radiotherapy based on the LRA is comparable to the standard
consolidation chemotherapy (COPDAC-28) plus standard involved node
radiotherapy.
Secondary outcome
- Evaluation of haematotoxicity during different chemotherapy regimens.
- For ERA positive patients to compare the late response assessment positivity
rates after consolidation chemotherapy with COPDAC-28 or DECOPDAC-21.
Outcome measures
The primary outcome is event-free survival (EFS) defined as time from start of
treatment until the first of the following events:
• progression/relapse of disease
• secondary malignancy
• death from any cause.
Secondary outcomes include efficacy, quality and safety endpoints.
Background summary
The standard treatment of classical Hodgkin lymphoma is chemotherapy in
combination with radiotherapy. Although the overall prognosis with this
treatment is excellent, both short and long term complications are of great
concern. The standard treatment of this protocol (EuroNet-PHL-C2) is based on
the EuroNet-PHL-C1 protocol. The results of the EuroNet-PHL-C1 protocol showed
an event free survival (EFS) of > 85% and the substitution of procarbazine by
dacarbazine appeared equally effective with less gonadotoxic effects. Moreover,
radiotherapy (RT) could be omitted in half of the patient population.
Study objective
The aim of this study is to reduce the indication for RT without compromising
cure rates. To investigate if intensified consolidation therapy (DECOPDAC-21)
compared to standard consolidation therapy (COPDAC-28) can compensate for
reduction in RT.
Study design
EuroNet-PHL-C2 is risk-stratified (defining chemotherapy) and response adapted
(defining radiotherapy). Former treatment groups (TG) of the EuroNet-PHL-C1
trial are reassigned into treatment levels (TL). Early stage patients (former
TG-1) with one of the new risk factors (ESR > 30 mm and tumor volume > 200 ml)
will be reassigned into TL-2.
All TL-2 and TL-3 patients will be randomized between respectively 2 or 4
standard COPDAC-28 or intensified DECOPDAC-21 consolidation chemotherapy
cycles.
Response to treatment is based on FDG-PET scans after the first two cycles of
OEPA (early response assessment; ERA). RT indication will be restricted. For
all patients with an adequate response at ERA, RT will be omitted. Patients in
TL-1 with an adequate response will receive 1 cycle of COPDAC-28.
For patients in TL-2 and TL-3 with an inadequate response at ERA, a late
response assessment (LRA) will be introduced after respectively 2 or 4 cycles
of consolidation chemotherapy. Patients receiving standard consolidation
therapy (COPDAC-28) will receive a boost of RT on LRA FDG-PET positive spots
besides the on ERA based standard RT. Patients randomized for intensified
consolidation chemotherapy (DECOPDAC-21) will receive no RT or restricted field
RT based on the LRA.
For Hodgkin Lymphoma, FDG-PET scans are formally integrated in the protocol.
Patient material and data will be collected centrally.
Intervention
Not applicable
Study burden and risks
There is no increased risk or burden compared for the standard treatment
consisting of chemo- and radiotherapy. It is possible that the intensified
chemotherapy has more side-effects or toxicity compared to the standard
therapy.
Feulgenstraße 12
Giessen 35385
NL
Feulgenstraße 12
Giessen 35385
NL
Listed location countries
Age
Inclusion criteria
• histologically confirmed primary diagnosis of classical Hodgkin*s lymphoma
• patients under 18 years of age on the date of written informed consent. In
specialized Teenage and Young Adult (TYA) units in France, Italy and UK
patients up to under 25 years of age can also be enrolled. Lower age limits
will be country specific according to national laws or formal insurance
requirements that may preclude very young patients.
• written informed consent of the patient and/or the patient*s parents or
guardian according to national laws
• negative pregnancy test within 2 weeks prior to starting treatment for female
patients with childbearing potential
Exclusion criteria
• prior chemotherapy or radiotherapy for other malignancies
• pre-treatment of Hodgkin*s lymphoma (except for 7-10 days steroid pre-phase
of a large mediastinal tumour)
• diagnosis of lymphocyte-predominant Hodgkin*s lymphoma
• other (simultaneous) malignancies
• contraindication or known hypersensitivity to study drugs
• severe concomitant diseases (e.g. immune deficiency syndrome)
• known HIV-positivity
• residence outside the participating countries where long term follow-up
cannot be guaranteed
• pregnancy and/or lactation
• patients who are sexually active and are unwilling to use adequate
contraception during therapy and for one month after last trial treatment
• current or recent (within 30 days prior to date of written informed consent)
treatment with another investigational drug or participation in another
interventional clinical trial
Design
Recruitment
Medical products/devices used
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 | EUCTR2012-004053-88-NL |
| CCMO | NL47032.078.16 |