RT or No RT Following Chemotherapy in Treating Patients With Stage III/IV Hodgkin's Disease
Study Details
Study Description
Brief Summary
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 3 |
Detailed Description
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.
Study Design
Outcome Measures
Primary Outcome Measures
- Benefit of adjuvant involved field RT after entering complete remission with MOPP/ABV hybrid CT []
- Efficacy of MOPP/ABV hybrid CT []
Secondary Outcome Measures
- Relapse free survival []
- Overall survival []
Eligibility Criteria
Criteria
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
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Algemeen Ziekenhuis Middelheim | Antwerp | Belgium | 2020 | |
| 2 | A.Z. St. Jan | Brugge | Belgium | 8000 | |
| 3 | C.H.U. Saint-Pierre | Brussels (Bruxelles) | Belgium | 1000 | |
| 4 | Institut Jules Bordet | Brussels (Bruxelles) | Belgium | 1000 | |
| 5 | Centre Hospitalier Universitaire Brugmann | Brussels (Bruxelles) | Belgium | B 1020 | |
| 6 | Hopital Universitaire Erasme | Brussels | Belgium | 1070 | |
| 7 | Centre Hospitalier Universitaire de Tivoli | La Louviere | Belgium | 7100 | |
| 8 | U.Z. Gasthuisberg | Leuven | Belgium | B-3000 | |
| 9 | U.Z. Sint-Rafael | Leuven | Belgium | B-3000 | |
| 10 | National Cancer Institute of Egypt | Cairo | Egypt | ||
| 11 | Institut Bergonie | Bordeaux | France | 33076 | |
| 12 | Centre Regional Francois Baclesse | Caen | France | 14076 | |
| 13 | Centre Hospitalier General | Compiegne | France | 60321 | |
| 14 | Centre Georges-Francois Leclerc | Dijon | France | 21034 | |
| 15 | Centre Leon Berard | Lyon | France | 69373 | |
| 16 | Hopital Edouard Herriot | Lyon | France | 69437 | |
| 17 | Centre Antoine Lacassagne | Nice | France | 06189 | |
| 18 | Hotel Dieu de Paris | Paris | France | 75181 | |
| 19 | Hopital Saint Antoine | Paris | France | 75571 | |
| 20 | Hopital Cochin | Paris | France | 75674 | |
| 21 | Hopital Necker | Paris | France | 75743 | |
| 22 | Hopital Jules Courmont - Centre Hospitalier Lyon Sud | Pierre Benite | France | 69495 | |
| 23 | Hopital Sud | Rennes | France | 35056 | |
| 24 | Centre Henri Becquerel | Rouen | France | 76038 | |
| 25 | Centre Medico-Chirurgical Foch | Suresnes | France | 92151 | |
| 26 | Centre Alexis Vautrin | Vandoeuvre-les-Nancy | France | 54511 | |
| 27 | Institut Gustave Roussy | Villejuif | France | F-94805 | |
| 28 | Zentralkrankenhaus | Bremen | Germany | D-28205 | |
| 29 | Centro di Riferimento Oncologico - Aviano | Aviano | Italy | 33081 | |
| 30 | Dipartimente di Oncologia di Torino | Turin (Torino) | Italy | 10123 | |
| 31 | Leyenburg Ziekenhuis | 's-Gravenhage (Den Haag, The Hague) | Netherlands | 2545 CH | |
| 32 | Groot Ziekengasthuis 's-Hertogenbosch | 's-Hertogenbosch | Netherlands | 5211 NL | |
| 33 | Medisch Centrum Alkmaar | Alkmaar | Netherlands | 1815 JD | |
| 34 | Antoni van Leeuwenhoekhuis | Amsterdam | Netherlands | 1066 CX | |
| 35 | Integraal Kankercentrum Amsterdam | Amsterdam | Netherlands | 1066 CX | |
| 36 | Slotervaart Ziekenhuis | Amsterdam | Netherlands | 1066 EC | |
| 37 | Onze Lieve Vrouwe Gasthuis | Amsterdam | Netherlands | 1091 HA | |
| 38 | Streekziekenhuizen Gooi-Noord | Blaricum | Netherlands | 1261 AN | |
| 39 | Catharina Ziekenhuis | Eindhoven | Netherlands | 5602 ZA | |
| 40 | Medisch Spectrum Twente | Enschede | Netherlands | 7500 KA | |
| 41 | De Wever Ziekenhuis | Heerlen | Netherlands | 6419 PC | |
| 42 | Radiotherapeutisch Instituut | Leeuwarden | Netherlands | 8934 AD | |
| 43 | Leiden University Medical Center | Leiden | Netherlands | 2300 ZA | |
| 44 | Integraal Kankercentrum West | Leiden | Netherlands | 2316 XB | |
| 45 | Academisch Ziekenhuis Maastricht | Maastricht | Netherlands | 6202 AZ | |
| 46 | St. Radboud University Hospital | Nijmegen | Netherlands | 6500 HB | |
| 47 | University Hospital - Rotterdam Dijkzigt | Rotterdam | Netherlands | 3000 CA | |
| 48 | Rotterdam Cancer Institute | Rotterdam | Netherlands | 3075 EA | |
| 49 | Sophia Ziekehuis | Zwolle | Netherlands | 8000 GK | |
| 50 | Maritime Hospital | Gdynia | Poland | PL-81--519 | |
| 51 | Jagiellonian University | Krakow (Cracow) | Poland | 31-826 | |
| 52 | Maria Sklodowska-Curie Memorial Cancer Center and Institute of Oncology | Warsaw | Poland | 02-781 | |
| 53 | Hospitais da Universidade de Coimbra (HUC) | Coimbra | Portugal | 3049 | |
| 54 | Instituto Portugues de Oncologia de Francisco Gentil | Lisbon | Portugal | 1093 | |
| 55 | Instituto Portugues de Oncologia do Porto | Porto | Portugal | 4200 | |
| 56 | Institute of Oncology, Ljubljana | Ljubljana | Slovenia | Sl-1000 |
Sponsors and Collaborators
- European Organisation for Research and Treatment of Cancer - EORTC
Investigators
- Study Chair: John Raemaekers, MD, PhD, Universitair Medisch Centrum St. Radboud - Nijmegen
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- EORTC-20884
- EORTC-20884