RT or No RT Following Chemotherapy in Treating Patients With Stage III/IV Hodgkin's Disease
- Conditions
- Lymphoma
- Registration Number
- NCT00002462
- 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.
- 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.
Recruitment & Eligibility
- Status
- ACTIVE_NOT_RECRUITING
- Sex
- All
- Target Recruitment
- 615
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Benefit of adjuvant involved field RT after entering complete remission with MOPP/ABV hybrid CT Efficacy of MOPP/ABV hybrid CT
- Secondary Outcome Measures
Name Time Method Relapse free survival Overall survival
Trial Locations
- Locations (56)
Centro di Riferimento Oncologico - Aviano
🇮🇹Aviano, Italy
Hopital Necker
🇫🇷Paris, France
Integraal Kankercentrum Amsterdam
🇳🇱Amsterdam, Netherlands
Streekziekenhuizen Gooi-Noord
🇳🇱Blaricum, Netherlands
Hopital Jules Courmont - Centre Hospitalier Lyon Sud
🇫🇷Pierre Benite, France
Zentralkrankenhaus
🇩🇪Bremen, Germany
Centre Leon Berard
🇫🇷Lyon, France
Medisch Centrum Alkmaar
🇳🇱Alkmaar, Netherlands
Antoni van Leeuwenhoekhuis
🇳🇱Amsterdam, Netherlands
Onze Lieve Vrouwe Gasthuis
🇳🇱Amsterdam, Netherlands
Hopital Edouard Herriot
🇫🇷Lyon, France
Hopital Saint Antoine
🇫🇷Paris, France
Hopital Cochin
🇫🇷Paris, France
Hopital Sud
🇫🇷Rennes, France
Slotervaart Ziekenhuis
🇳🇱Amsterdam, Netherlands
De Wever Ziekenhuis
🇳🇱Heerlen, Netherlands
Radiotherapeutisch Instituut
🇳🇱Leeuwarden, Netherlands
Centre Henri Becquerel
🇫🇷Rouen, France
Institut Gustave Roussy
🇫🇷Villejuif, France
Catharina Ziekenhuis
🇳🇱Eindhoven, Netherlands
Dipartimente di Oncologia di Torino
🇮🇹Turin (Torino), Italy
Centre Alexis Vautrin
🇫🇷Vandoeuvre-les-Nancy, France
Centre Medico-Chirurgical Foch
🇫🇷Suresnes, France
Jagiellonian University
🇵🇱Krakow (Cracow), Poland
Leyenburg Ziekenhuis
🇳🇱's-Gravenhage (Den Haag, The Hague), Netherlands
Groot Ziekengasthuis 's-Hertogenbosch
🇳🇱's-Hertogenbosch, Netherlands
Instituto Portugues de Oncologia de Francisco Gentil
🇵🇹Lisbon, Portugal
Academisch Ziekenhuis Maastricht
🇳🇱Maastricht, Netherlands
Instituto Portugues de Oncologia do Porto
🇵🇹Porto, Portugal
Maritime Hospital
🇵🇱Gdynia, Poland
Maria Sklodowska-Curie Memorial Cancer Center and Institute of Oncology
🇵🇱Warsaw, Poland
Medisch Spectrum Twente
🇳🇱Enschede, Netherlands
Integraal Kankercentrum West
🇳🇱Leiden, Netherlands
University Hospital - Rotterdam Dijkzigt
🇳🇱Rotterdam, Netherlands
Sophia Ziekehuis
🇳🇱Zwolle, Netherlands
Institut Jules Bordet
🇧🇪Brussels (Bruxelles), Belgium
Centre Hospitalier Universitaire Brugmann
🇧🇪Brussels (Bruxelles), Belgium
A.Z. St. Jan
🇧🇪Brugge, Belgium
C.H.U. Saint-Pierre
🇧🇪Brussels (Bruxelles), Belgium
Algemeen Ziekenhuis Middelheim
🇧🇪Antwerp, Belgium
Hopital Universitaire Erasme
🇧🇪Brussels, Belgium
Centre Hospitalier Universitaire de Tivoli
🇧🇪La Louviere, Belgium
U.Z. Gasthuisberg
🇧🇪Leuven, Belgium
U.Z. Sint-Rafael
🇧🇪Leuven, Belgium
National Cancer Institute of Egypt
🇪🇬Cairo, Egypt
Centre Hospitalier General
🇫🇷Compiegne, France
Centre Antoine Lacassagne
🇫🇷Nice, France
St. Radboud University Hospital
🇳🇱Nijmegen, Netherlands
Leiden University Medical Center
🇳🇱Leiden, Netherlands
Rotterdam Cancer Institute
🇳🇱Rotterdam, Netherlands
Hospitais da Universidade de Coimbra (HUC)
🇵🇹Coimbra, Portugal
Institute of Oncology, Ljubljana
🇸🇮Ljubljana, Slovenia
Hotel Dieu de Paris
🇫🇷Paris, France
Centre Georges-Francois Leclerc
🇫🇷Dijon, France
Institut Bergonie
🇫🇷Bordeaux, France
Centre Regional Francois Baclesse
🇫🇷Caen, France