RT or No RT Following Chemotherapy in Treating Patients With Stage III/IV Hodgkin's Disease

Lymphoma Clinical Trial

Official title:

Phase III Randomized Trial of Adjuvant Involved-Field Radiotherapy vs No Adjuvant Therapy Following Remission Induction With MOPP/ABV Hybrid Chemotherapy in Patients With Stage III/IV Hodgkin's Disease

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT00002462
• Other study ID #: EORTC-20884
• Secondary ID: EORTC-20884
• Status: Active, not recruiting
• Phase: Phase 3
• Start date: September 1989

Study information

• Verified date: February 2024
• Source: European Organisation for Research and Treatment of Cancer - EORTC
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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 information / eligibility

• Status: Active, not recruiting
• Enrollment: 615
• Est. primary completion date: May 2000
• Accepts healthy volunteers: No
• Gender: All
• Age group: 15 Years to 70 Years

Eligibility

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

Related Conditions & MeSH terms

• Hodgkin Disease
• Lymphoma

Intervention

Biological:
• bleomycin sulfate

Drug:
• doxorubicin hydrochloride

• mechlorethamine hydrochloride

• prednisone

• procarbazine hydrochloride

• vinblastine sulfate

• vincristine sulfate

Radiation:
• low-LET cobalt-60 gamma ray therapy

• low-LET photon therapy

• radiation therapy

Locations

Country	Name	City	State
Belgium	Algemeen Ziekenhuis Middelheim	Antwerp
Belgium	A.Z. St. Jan	Brugge
Belgium	Hopital Universitaire Erasme	Brussels
Belgium	C.H.U. Saint-Pierre	Brussels (Bruxelles)
Belgium	Centre Hospitalier Universitaire Brugmann	Brussels (Bruxelles)
Belgium	Institut Jules Bordet	Brussels (Bruxelles)
Belgium	Centre Hospitalier Universitaire de Tivoli	La Louviere
Belgium	U.Z. Gasthuisberg	Leuven
Belgium	U.Z. Sint-Rafael	Leuven
Egypt	National Cancer Institute of Egypt	Cairo
France	Institut Bergonie	Bordeaux
France	Centre Regional Francois Baclesse	Caen
France	Centre Hospitalier General	Compiegne
France	Centre Georges-Francois Leclerc	Dijon
France	Centre Leon Berard	Lyon
France	Hopital Edouard Herriot	Lyon
France	Centre Antoine Lacassagne	Nice
France	Hopital Cochin	Paris
France	Hopital Necker	Paris
France	Hopital Saint Antoine	Paris
France	Hotel Dieu de Paris	Paris
France	Hopital Jules Courmont - Centre Hospitalier Lyon Sud	Pierre Benite
France	Hopital Sud	Rennes
France	Centre Henri Becquerel	Rouen
France	Centre Medico-Chirurgical Foch	Suresnes
France	Centre Alexis Vautrin	Vandoeuvre-les-Nancy
France	Institut Gustave Roussy	Villejuif
Germany	Zentralkrankenhaus	Bremen
Italy	Centro di Riferimento Oncologico - Aviano	Aviano
Italy	Dipartimente di Oncologia di Torino	Turin (Torino)
Netherlands	Leyenburg Ziekenhuis	's-Gravenhage (Den Haag, The Hague)
Netherlands	Groot Ziekengasthuis 's-Hertogenbosch	's-Hertogenbosch
Netherlands	Medisch Centrum Alkmaar	Alkmaar
Netherlands	Antoni van Leeuwenhoekhuis	Amsterdam
Netherlands	Integraal Kankercentrum Amsterdam	Amsterdam
Netherlands	Onze Lieve Vrouwe Gasthuis	Amsterdam
Netherlands	Slotervaart Ziekenhuis	Amsterdam
Netherlands	Streekziekenhuizen Gooi-Noord	Blaricum
Netherlands	Catharina Ziekenhuis	Eindhoven
Netherlands	Medisch Spectrum Twente	Enschede
Netherlands	De Wever Ziekenhuis	Heerlen
Netherlands	Radiotherapeutisch Instituut	Leeuwarden
Netherlands	Integraal Kankercentrum West	Leiden
Netherlands	Leiden University Medical Center	Leiden
Netherlands	Academisch Ziekenhuis Maastricht	Maastricht
Netherlands	St. Radboud University Hospital	Nijmegen
Netherlands	Rotterdam Cancer Institute	Rotterdam
Netherlands	University Hospital - Rotterdam Dijkzigt	Rotterdam
Netherlands	Sophia Ziekehuis	Zwolle
Poland	Maritime Hospital	Gdynia
Poland	Jagiellonian University	Krakow (Cracow)
Poland	Maria Sklodowska-Curie Memorial Cancer Center and Institute of Oncology	Warsaw
Portugal	Hospitais da Universidade de Coimbra (HUC)	Coimbra
Portugal	Instituto Portugues de Oncologia de Francisco Gentil	Lisbon
Portugal	Instituto Portugues de Oncologia do Porto	Porto
Slovenia	Institute of Oncology, Ljubljana	Ljubljana

Sponsors (1)

Lead Sponsor	Collaborator
European Organisation for Research and Treatment of Cancer - EORTC

Countries where clinical trial is conducted

Belgium,  Egypt,  France,  Germany,  Italy,  Netherlands,  Poland,  Portugal,  Slovenia, 

References & Publications (6)

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 — View Citation

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.

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 G — View Citation

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.

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-A

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 — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Benefit of adjuvant involved field RT after entering complete remission with MOPP/ABV hybrid CT
Primary	Efficacy of MOPP/ABV hybrid CT
Secondary	Relapse free survival
Secondary	Overall survival