Radiation Therapy or No Radiation Therapy Following Chemotherapy in Treating Patients With Stage III or Stage IV Hodgkin's Disease

The recruitment status of this study is unknown because the information has not been verified recently.
Verified November 2006 by National Cancer Institute (NCI).
Recruitment status was  Active, not recruiting
Sponsor:
Information provided by:
National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:
NCT00002462
First received: November 1, 1999
Last updated: November 2, 2010
Last verified: November 2006
  Purpose

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 Intervention Phase
Lymphoma
Biological: bleomycin sulfate
Drug: doxorubicin hydrochloride
Drug: mechlorethamine hydrochloride
Drug: prednisone
Drug: procarbazine hydrochloride
Drug: vinblastine sulfate
Drug: vincristine sulfate
Radiation: low-LET cobalt-60 gamma ray therapy
Radiation: low-LET photon therapy
Radiation: radiation therapy
Phase 3

Study Type: Interventional
Study Design: Primary Purpose: Treatment
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

Resource links provided by NLM:


Further study details as provided by National Cancer Institute (NCI):

Study Start Date: September 1989
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.

  Eligibility

Ages Eligible for Study:   15 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00002462

  Show 56 Study Locations
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
  More Information

Additional Information:
Publications:
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-A01, 42, 2004.
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.

ClinicalTrials.gov Identifier: NCT00002462     History of Changes
Other Study ID Numbers: CDR0000075903, EORTC-20884
Study First Received: November 1, 1999
Last Updated: November 2, 2010
Health Authority: United States: Federal Government

Keywords provided by National Cancer Institute (NCI):
stage III adult Hodgkin lymphoma
stage IV adult Hodgkin lymphoma

Additional relevant MeSH terms:
Lymphoma
Hodgkin Disease
Neoplasms by Histologic Type
Neoplasms
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Doxorubicin
Liposomal doxorubicin
Bleomycin
Vincristine
Vinblastine
Procarbazine
Mechlorethamine
Antibiotics, Antineoplastic
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Topoisomerase II Inhibitors
Topoisomerase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents, Phytogenic
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Alkylating Agents
Antineoplastic Agents, Alkylating

ClinicalTrials.gov processed this record on September 18, 2014