First international Inter-Group Study for classical Hodgkin's Lymphoma in Children and Adolescents
- Conditions
- classical Hodgkin's Lymphoma10025319
- Registration Number
- NL-OMON41689
- Lead Sponsor
- Stichting Kinderoncologie Nederland
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 34
* 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
* 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
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>1. Are 5 year event free survival (EFS) rate estimates in patients with<br /><br>adequate response after 2 OEPA treated without radiotherapy consistent with a<br /><br>target EFS rate of 90% in all treatment groups? 2. Can Procarbazine be safely<br /><br>replaced by Dacarbazine in therapy groups TG-2 and TG-3 without a deterioration<br /><br>of EFS (randomised comparison of COPDAC and COPP)? 3. Description of treatment<br /><br>outcome to a standardised risk adapted relapse strategy</p><br>
- Secondary Outcome Measures
Name Time Method <p>1. Is the 5 year event free survival (EFS) rate in patients with inadequate<br /><br>response after 2 OEPA who receive standard involved field radiotherapy<br /><br>consistent with a target EFS rate of 90% estimates in all treatment groups? 2.<br /><br>Does substitution of Dacarbazine for Procarbazine in TG-2 and - 3 patients<br /><br>decrease the rate of infertility in males and premature ovarian failure for<br /><br>females? 3. Does a positive PET finding before planned high-dose chemotherapy<br /><br>with autologous stem cell transplantation have a negative prognostic<br /><br>significance?</p><br>