The objective of the study is to diminish the amount of chemotherapy and/ or radiotherapy for children with Hodgkin lymphoma who are likely to receive too much treatment with current treatment protocols.
ID
Source
Brief title
Condition
- Lymphomas Hodgkin's disease
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
1. Are 5 year event free survival (EFS) rate estimates in patients with
adequate response after 2 OEPA treated without radiotherapy consistent with a
target EFS rate of 90% in all treatment groups? 2. Can Procarbazine be safely
replaced by Dacarbazine in therapy groups TG-2 and TG-3 without a deterioration
of EFS (randomised comparison of COPDAC and COPP)? 3. Description of treatment
outcome to a standardised risk adapted relapse strategy
Secondary outcome
1. Is the 5 year event free survival (EFS) rate in patients with inadequate
response after 2 OEPA who receive standard involved field radiotherapy
consistent with a target EFS rate of 90% estimates in all treatment groups? 2.
Does substitution of Dacarbazine for Procarbazine in TG-2 and - 3 patients
decrease the rate of infertility in males and premature ovarian failure for
females? 3. Does a positive PET finding before planned high-dose chemotherapy
with autologous stem cell transplantation have a negative prognostic
significance?
Background summary
Current treatment protocols in paediatric Hodgkin*s lymphoma consist of
chemotherapy combined with or without radiotherapy. With these treatment
modalities survival rates are high (> 90%). The remaining challenges for
further treatment optimisation are: reduction of acute and long-term toxicity
of the chemotherapy and radiotherapy employed and reduction of the amount of
treatment in those children who are currently over-treated. The standard arm in
this protocol is based on the German (GPOH-HD) studies applied for Hodgkin
lymphoma in children the last decades.
Study objective
The objective of the study is to diminish the amount of chemotherapy and/ or
radiotherapy for children with Hodgkin lymphoma who are likely to receive too
much treatment with current treatment protocols.
Study design
Based on the disease stage patients will be stratified in three different
treatment groups. The disease stage determines the chemotherapy dosage for each
patient. All patients start with two cycles of OEPA. Thereafter, response
assessment will be done with a FDG-PET scan. Radiotherapy after completion of
chemotherapy will be omitted in patients with adequate response. For Hodgkin*s
lymphoma a FDG-PET currently is routinely used in most centres. Results of
FDG-PET are now formally integrated both into staging and response assessment.
.
Intervention
In treatment group two and three patients are randomized for the standard
course COPP (with Procarbazine) and the intervention course COPDAC (with
Dacarbazine). Procarbazine can cause infertility. Substitution of Dacarbazine
for Procarbazine should decrease the rate of infertility in males and premature
ovarian failure in females, with the same efficacy.
Study burden and risks
Hodgkin lymphoma can only be cured by radiotherapy and/ or chemotherapy.
Toxicity caused by these treatment modalities is known. There is no extra risk
for patients treated according to the intervention arm.
Postbus 43515
Den Haag 2504 AM
NL
Postbus 43515
Den Haag 2504 AM
NL
Listed location countries
Age
Inclusion criteria
* diagnosis of classic Hodgkin*s lymphoma
* patient aged under 18 years at time of diagnosis
* written informed consent of the patient and/or the patient*s parents or guardian
according to national laws
Exclusion criteria
* pre-treatment of Hodgkin*s lymphoma differing from study protocol (except
recommended pre-phase therapy of a large mediastinal tumour)
* known hypersensitivity or contraindication to study drugs
* diagnosis of lymphocyte predominant Hodgkin*s lymphoma
* prior chemotherapy or radiotherapy
* other (simultaneous) malignancies
* pregnancy and / or lactation
* females who are sexually active refusing to use effective contraception (oral
contraception, intrauterine devices, barrier method of contraception in conjunction with
spermicidal jelly or surgical sterile)
* Current or recent (within 30 days prior to start of trial treatment) treatment with another
investigational drug or participation in another investigational trial
* severe concomitant diseases (e.g. immune deficiency syndrome)
* known HIV positivity
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 | EUCTR2006-000995-33-NL |
| CCMO | NL33537.078.10 |