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| ID | Type | Description | Link |
|---|---|---|---|
| EORTC-20884 | Other Identifier | EORTC |
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RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining radiation therapy with combination chemotherapy may kill more tumor cells.
PURPOSE: Randomized phase III trial to compare the effectiveness of radiation therapy with no radiation therapy following chemotherapy in treating patients with stage III or stage IV Hodgkin's disease.
OBJECTIVES: I. Compare relapse-free survival and overall survival of patients with Stage III/IV Hodgkin's disease randomly assigned to adjuvant involved-field radiotherapy vs. no adjuvant therapy following remission induction with MOPP/ABV (nitrogen mustard/vincristine/procarbazine/prednisone/doxorubicin/bleomycin/vinblastine). II. Evaluate the therapeutic efficacy of MOPP/ABV hybrid chemotherapy in advanced Hodgkin's disease. III. Evaluate the prognostic significance of an early response to MOPP/ABV in patients with advanced Hodgkin's disease.
OUTLINE: Study randomized for adjuvant radiotherapy. All patients receive Induction chemotherapy on Regimen A, following which those in CR are randomized on Arms I and II. Regimen A: 7-Drug Combination Chemotherapy. MOPP/ABV Hybrid. Mechlorethamine, NM, NSC-762; Vincristine, VCR, NSC-67574; Procarbazine, PCB, NSC-77213; Prednisone, PRED, NSC-10023; Doxorubicin, DOX, NSC-123127; Bleomycin, BLEO, NSC-125066; Vinblastine, VBL, NSC-49842. Arm I: Radiotherapy. Involved-field irradiation using megavoltage equipment. Arm II: No further therapy.
PROJECTED ACCRUAL: 321 evaluable patients will be required; an annual accrual rate of 80 patients is anticipated.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| bleomycin sulfate | Biological | |||
| doxorubicin hydrochloride | Drug | |||
| mechlorethamine hydrochloride | Drug | |||
| prednisone | Drug | |||
| procarbazine hydrochloride | Drug | |||
| vinblastine sulfate | Drug | |||
| vincristine sulfate | Drug | |||
| Measure | Description | Time Frame |
|---|---|---|
| Benefit of adjuvant involved field RT after entering complete remission with MOPP/ABV hybrid CT | ||
| Efficacy of MOPP/ABV hybrid CT |
| Measure | Description | Time Frame |
|---|---|---|
| Relapse free survival | ||
| Overall survival |
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DISEASE CHARACTERISTICS: Histologically proven clinical or pathological Stage III/IV Hodgkin's disease Pathological Stage IIIAS disease with the spleen as the only site of subdiaphragmatic involvement excluded
PATIENT CHARACTERISTICS: Age: 15 to 70 Performance status: Not specified Life expectancy: No severe limits on life expectancy due to nonmalignant disease Hematopoietic: Not specified Hepatic: Not specified Renal: Not specified Cardiovascular: No severe cardiac disease that would preclude protocol therapy Pulmonary: No severe pulmonary disease that would preclude protocol therapy Other: No severe metabolic or neurologic disease that would preclude protocol therapy No concomitant or previous second malignancy except: Nonmelanomatous skin cancer In situ carcinoma of the cervix
PRIOR CONCURRENT THERAPY: No prior therapy
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| Name | Affiliation | Role |
|---|---|---|
| John Raemaekers, MD, PhD | Universitair Medisch Centrum St. Radboud - Nijmegen | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Algemeen Ziekenhuis Middelheim | Antwerp | 2020 | Belgium | |||
| A.Z. St. Jan |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 17097834 | Result | Aleman BM, Raemaekers JM, Tomisic R, Baaijens MH, Bortolus R, Lybeert ML, van der Maazen RW, Girinsky T, Demeestere G, Lugtenburg P, Lievens Y, de Jong D, Pinna A, Henry-Amar M; European Organization for Research and Treatment of Cancer (EORTC) Lymphoma Group. Involved-field radiotherapy for patients in partial remission after chemotherapy for advanced Hodgkin's lymphoma. Int J Radiat Oncol Biol Phys. 2007 Jan 1;67(1):19-30. doi: 10.1016/j.ijrobp.2006.08.041. Epub 2006 Nov 9. | |
| 15936157 |
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| low-LET cobalt-60 gamma ray therapy |
| Radiation |
| low-LET photon therapy | Radiation |
| radiation therapy | Radiation |
| Bruges |
| 8000 |
| Belgium |
| Hopital Universitaire Erasme | Brussels | 1070 | Belgium |
| C.H.U. Saint-Pierre | Brussels (Bruxelles) | 1000 | Belgium |
| Institut Jules Bordet | Brussels (Bruxelles) | 1000 | Belgium |
| Centre Hospitalier Universitaire Brugmann | Brussels (Bruxelles) | B 1020 | Belgium |
| Centre Hospitalier Universitaire de Tivoli | La Louvière | 7100 | Belgium |
| U.Z. Gasthuisberg | Leuven | B-3000 | Belgium |
| U.Z. Sint-Rafael | Leuven | B-3000 | Belgium |
| National Cancer Institute of Egypt | Cairo | Egypt |
| Institut Bergonie | Bordeaux | 33076 | France |
| Centre Regional Francois Baclesse | Caen | 14076 | France |
| Centre Hospitalier General | Compiègne | 60321 | France |
| Centre Georges-Francois Leclerc | Dijon | 21034 | France |
| Centre Leon Berard | Lyon | 69373 | France |
| Hopital Edouard Herriot | Lyon | 69437 | France |
| Centre Antoine Lacassagne | Nice | 06189 | France |
| Hotel Dieu de Paris | Paris | 75181 | France |
| Hopital Saint Antoine | Paris | 75571 | France |
| Hopital Cochin | Paris | 75674 | France |
| Hopital Necker | Paris | 75743 | France |
| Hopital Jules Courmont - Centre Hospitalier Lyon Sud | Pierre-Bénite | 69495 | France |
| Hopital Sud | Rennes | 35056 | France |
| Centre Henri Becquerel | Rouen | 76038 | France |
| Centre Medico-Chirurgical Foch | Suresnes | 92151 | France |
| Centre Alexis Vautrin | Vandœuvre-lès-Nancy | 54511 | France |
| Institut Gustave Roussy | Villejuif | F-94805 | France |
| Zentralkrankenhaus | Bremen | D-28205 | Germany |
| Centro di Riferimento Oncologico - Aviano | Aviano | 33081 | Italy |
| Dipartimente di Oncologia di Torino | Turin (Torino) | 10123 | Italy |
| Leyenburg Ziekenhuis | 's-Gravenhage (Den Haag, the Hague) | 2545 CH | Netherlands |
| Groot Ziekengasthuis 's-Hertogenbosch | 's-Hertogenbosch | 5211 NL | Netherlands |
| Medisch Centrum Alkmaar | Alkmaar | 1815 JD | Netherlands |
| Antoni van Leeuwenhoekhuis | Amsterdam | 1066 CX | Netherlands |
| Integraal Kankercentrum Amsterdam | Amsterdam | 1066 CX | Netherlands |
| Slotervaart Ziekenhuis | Amsterdam | 1066 EC | Netherlands |
| Onze Lieve Vrouwe Gasthuis | Amsterdam | 1091 HA | Netherlands |
| Streekziekenhuizen Gooi-Noord | Blaricum | 1261 AN | Netherlands |
| Catharina Ziekenhuis | Eindhoven | 5602 ZA | Netherlands |
| Medisch Spectrum Twente | Enschede | 7500 KA | Netherlands |
| De Wever Ziekenhuis | Heerlen | 6419 PC | Netherlands |
| Radiotherapeutisch Instituut | Leeuwarden | 8934 AD | Netherlands |
| Leiden University Medical Center | Leiden | 2300 ZA | Netherlands |
| Integraal Kankercentrum West | Leiden | 2316 XB | Netherlands |
| Academisch Ziekenhuis Maastricht | Maastricht | 6202 AZ | Netherlands |
| St. Radboud University Hospital | Nijmegen | 6500 HB | Netherlands |
| University Hospital - Rotterdam Dijkzigt | Rotterdam | 3000 CA | Netherlands |
| Rotterdam Cancer Institute | Rotterdam | 3075 EA | Netherlands |
| Sophia Ziekehuis | Zwolle | 8000 GK | Netherlands |
| Maritime Hospital | Gdynia | PL-81--519 | Poland |
| Jagiellonian University | Krakow (Cracow) | 31-826 | Poland |
| Maria Sklodowska-Curie Memorial Cancer Center and Institute of Oncology | Warsaw | 02-781 | Poland |
| Hospitais da Universidade de Coimbra (HUC) | Coimbra | 3049 | Portugal |
| Instituto Portugues de Oncologia de Francisco Gentil | Lisbon | 1093 | Portugal |
| Instituto Portugues de Oncologia do Porto | Porto | 4200 | Portugal |
| Institute of Oncology, Ljubljana | Ljubljana | Sl-1000 | Slovenia |
| Result |
| Aleman BM, Girinsky T, van der Maazen RW, Strijk S, Meijnders P, Bortolus R, Olofsen-van Acht MJ, Lybeert ML, Lievens Y, Eghbali H, Noordijk EM, Tomsic R, Meerwaldt JH, Poortmans PM, Smit WG, Pinna A, Henry-Amar M, Raemaekers JM; European Organization for Research; Treatment of Cancer (EORTC) Lymphoma Group. Quality control of involved-field radiotherapy in patients with advanced Hodgkin's lymphoma (EORTC 20884). Int J Radiat Oncol Biol Phys. 2005 Nov 15;63(4):1184-90. doi: 10.1016/j.ijrobp.2005.03.044. Epub 2005 Jun 2. |
| Result | Aleman BMP, Girinsky T, Strijk S, et al.: Quality control of involved-field radiotherapy in patients with advanced stage Hodgkin's lymphoma (HL) enrolled on the EORTC trial 20884. [Abstract] Eur J Haematol 73 (Suppl 65): A-A02, 42, 2004. |
| Result | Aleman BMP, Raemaekers JMM, Tomsic R, et al.: Radiotherapy in advanced Hodgkin lymphoma (HL) patients in partial remission (PR) after chemotherapy: detailed results from the EORTC lymphoma group trial no.20884. [Abstract] Eur J Haematol 73 (Suppl 65): A-A01, 42, 2004. |
| Result | Aleman BM, Raemaekers JM, Henry-Amar M, et al.: Involved-field radiotherapy in patients with stage III/IV Hodgkin's lymphoma: first results of the randomised EORTC trial # 20884. [Abstract] Int J Radiat Oncol Biol Phys 51(3 suppl 1): A-3, 2, 2001. |
| 9187443 | Result | Raemaekers J, Burgers M, Henry-Amar M, Pinna A, Mandard A, Monfardini S, Hagenbeek A, Breed W, Carde P, Vovk M, van Hoof A, Thomas J, Noordijk E. Patients with stage III/IV Hodgkin's disease in partial remission after MOPP/ABV chemotherapy have excellent prognosis after additional involved-field radiotherapy: interim results from the ongoing EORTC-LCG and GPMC phase III trial. The EORTC Lymphoma Cooperative Group and Groupe Pierre-et-Marie-Curie. Ann Oncol. 1997;8 Suppl 1:111-4. |
| ID | Term |
|---|---|
| D008223 | Lymphoma |
| D006689 | Hodgkin Disease |
| ID | Term |
|---|---|
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D008232 | Lymphoproliferative Disorders |
| D008206 | Lymphatic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D007160 | Immunoproliferative Disorders |
| D007154 | Immune System Diseases |
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| ID | Term |
|---|---|
| D001761 | Bleomycin |
| D004317 | Doxorubicin |
| D008466 | Mechlorethamine |
| D011241 | Prednisone |
| D011344 | Procarbazine |
| D014747 | Vinblastine |
| D014750 | Vincristine |
| D011878 | Radiotherapy |
| ID | Term |
|---|---|
| D006020 | Glycopeptides |
| D006001 | Glycoconjugates |
| D002241 | Carbohydrates |
| D010455 | Peptides |
| D000602 | Amino Acids, Peptides, and Proteins |
| D003630 | Daunorubicin |
| D018943 | Anthracyclines |
| D009279 | Naphthacenes |
| D011084 | Polycyclic Aromatic Hydrocarbons |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
| D011083 | Polycyclic Compounds |
| D000617 | Aminoglycosides |
| D006027 | Glycosides |
| D009588 | Nitrogen Mustard Compounds |
| D009150 | Mustard Compounds |
| D006846 | Hydrocarbons, Halogenated |
| D011244 | Pregnadienediols |
| D011245 | Pregnadienes |
| D011278 | Pregnanes |
| D013256 | Steroids |
| D000072473 | Fused-Ring Compounds |
| D001549 | Benzamides |
| D000577 | Amides |
| D001565 | Benzoates |
| D000146 | Acids, Carbocyclic |
| D002264 | Carboxylic Acids |
| D001555 | Benzene Derivatives |
| D014748 | Vinca Alkaloids |
| D046948 | Secologanin Tryptamine Alkaloids |
| D026121 | Indole Alkaloids |
| D000470 | Alkaloids |
| D006571 | Heterocyclic Compounds |
| D007211 | Indoles |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D054836 | Indolizidines |
| D007212 | Indolizines |
| D013812 | Therapeutics |
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