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| Name | Class |
|---|---|
| University of Giessen | OTHER |
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Reduction of the indication for radiotherapy (RT) in newly diagnosed patients with classical Hodgkins lymphoma without compromising cure rates. Investigation of a chemotherapy intensification randomisation in intermediate and advanced classical Hodgkins lymphoma patients to compensate for reduction in RT.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| A-"COPDAC-28" | Other | standard COPDAC-28 (chemotherapy cycle:Cyclophosphamide,Doxorubicin,Prednisone,Dacarbazine), chemotherapy and standard involved node radiotherapy. drugs: Prednisone 40mg/m2/day,P.O,day 1-day 15. Dacarbazine 250mg/m2, I.V. , infusion,day 1- day 3. Vincristine 15mg/m2 , I.V. , day1+day 8. Cyclophosphamide 500mg/m2,infusion,day 1+day 8. |
|
| B- "DECOPDAC-21" | Experimental | DECOPDAC-21(chemotherapy cycle:Dacarbazine,Etoposide,Doxorubicin,Cyclophosphamide,Prednisone,Vincristine) intensified chemotherapy and no RT or restricted fields of radiotherapy. Drugs: Prednisone 40mg/m2/day,P.O,day 1-day 15: Dacarbazine 250mg/m2, I.V. , infusion,day 1- day 3 Vincristine 15mg/m2 , I.V. , day1+day 8 Cyclophosphamide 625mg/m2,infusion,day1+day2 Etoposide 100mg/m2/day,infusion,day 1- day 3 Doxorubicin 25mg/m2, infusion, day 1 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Radiotherapy: | Radiation | All patients will have 2 "OPEA"cycles(chemotherapy cycle:Vincristine,Etoposide,Prednisone,doxorubicin) ,After assignment ( by randomization) to one of the arms the patient will be treated accordingly . response assessment will be done after "OPEA" cycles (ERA) and after cycles of "copdac 28" or DECOPDAC 21(LRA).according to the assessments results patients will have radiotherapy or not. |
| Measure | Description | Time Frame |
|---|---|---|
| Increase event free survival rate from 88% to 93% | Methods of measurement: chest X-ray; US neck, abdomen and pelvis; lung function; T4,Throid Stimulating Hormone ,US of thyroid; MRI of initially involved region; chest CT in patients with initial lung involvement. | Will be assessed once a year up to 5 years after end of treatment. |
| Measure | Description | Time Frame |
|---|---|---|
| comparison of haematotoxicity between arm A and arm B | Evaluation of haematotoxicity by documentation of blood count courses during "OEPA", COPDAC-28 and DECOPDAC-21 cycles. Comparison between COPDAC-28 versus DECOPDAC-21. For ERA(early response assessment) PET(Positron Emission Tomography)-positive patients to compare to the LRA (late response assessment)PET-positivity rates after consolidation chemotherapy with COPDAC-28 or DECOPDAC-21. |
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Inclusion Criteria:
Exclusion Criteria: (Patients with one or more of the following criterion are excluded)
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Galia Avrahami, MD | Contact | 972-3-9253356 | Galia2@clalit.org.il | |
| Michal Rada | Contact | 972-524-643166 | michalra6@clalit.org.il |
| Name | Affiliation | Role |
|---|---|---|
| Dieter K.rholz, Prof. Dr. | Universit.tsklinikum Giessen | Study Chair |
| Galia Avrahami, MD | Schneider children medical center,Kaplan 14 Petach-Tikva,Israel | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Schneider children's medical center | Recruiting | Petah Tikva | 4920235 | Israel |
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| ID | Term |
|---|---|
| D011878 | Radiotherapy |
| D014750 | Vincristine |
| D005047 | Etoposide |
| D011241 | Prednisone |
| D004317 | Doxorubicin |
| D003606 | Dacarbazine |
| D003520 | Cyclophosphamide |
| ID | Term |
|---|---|
| D013812 | Therapeutics |
| D014748 | Vinca Alkaloids |
| D046948 | Secologanin Tryptamine Alkaloids |
| D026121 | Indole Alkaloids |
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|
| Vincristine | Drug | ARM A and ARM B |
|
| Etoposide | Drug | ARM B , 100mg/m2/day |
|
| Prednisone | Drug | ARM A and ARM B , 40mg/m2/day p.o |
|
| Doxorubicin | Drug | ARM B , 25mg/m2 |
|
| Dacarbazine | Drug | ARM A and ARM B , 250mg/m2 i.v |
|
| Cyclophosphamide | Drug | ARM A and ARM B , 625mg/m2 i.v |
|
| Will be assessed in day 0,day 8,day 11,day 17 and day 21 of each cycle |
| D000470 |
| Alkaloids |
| D006571 | Heterocyclic Compounds |
| D007211 | Indoles |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D054836 | Indolizidines |
| D007212 | Indolizines |
| D011034 | Podophyllotoxin |
| D013764 | Tetrahydronaphthalenes |
| D009281 | Naphthalenes |
| D011084 | Polycyclic Aromatic Hydrocarbons |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
| D011083 | Polycyclic Compounds |
| D005960 | Glucosides |
| D006027 | Glycosides |
| D002241 | Carbohydrates |
| D011244 | Pregnadienediols |
| D011245 | Pregnadienes |
| D011278 | Pregnanes |
| D013256 | Steroids |
| D000072473 | Fused-Ring Compounds |
| D003630 | Daunorubicin |
| D018943 | Anthracyclines |
| D009279 | Naphthacenes |
| D000617 | Aminoglycosides |
| D014226 | Triazenes |
| D007093 | Imidazoles |
| D001393 | Azoles |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D010752 | Phosphoramide Mustards |
| D009588 | Nitrogen Mustard Compounds |
| D009150 | Mustard Compounds |
| D006846 | Hydrocarbons, Halogenated |
| D063088 | Phosphoramides |
| D009943 | Organophosphorus Compounds |