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

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
European Organisation for Research and Treatment of Cancer - EORTC
ClinicalTrials.gov Identifier:
NCT00002462
First received: November 1, 1999
Last updated: February 3, 2016
Last verified: February 2016

November 1, 1999
February 3, 2016
September 1989
May 2000   (final data collection date for primary outcome measure)
  • Benefit of adjuvant involved field RT after entering complete remission with MOPP/ABV hybrid CT [ Designated as safety issue: No ]
  • Efficacy of MOPP/ABV hybrid CT [ Designated as safety issue: No ]
Not Provided
Complete list of historical versions of study NCT00002462 on ClinicalTrials.gov Archive Site
  • Relapse free survival [ Designated as safety issue: No ]
  • Overall survival [ Designated as safety issue: No ]
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RT or No RT Following Chemotherapy in Treating Patients With Stage III/IV Hodgkin's Disease
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

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.

Interventional
Phase 3
Allocation: Randomized
Primary Purpose: Treatment
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
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
615
Not Provided
May 2000   (final data collection date for primary outcome measure)

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

Both
15 Years to 70 Years   (Child, Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
Belgium,   Egypt,   France,   Germany,   Italy,   Netherlands,   Poland,   Portugal,   Slovenia
 
NCT00002462
EORTC-20884, EORTC-20884
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European Organisation for Research and Treatment of Cancer - EORTC
European Organisation for Research and Treatment of Cancer - EORTC
Not Provided
Study Chair: John Raemaekers, MD, PhD Universitair Medisch Centrum St. Radboud - Nijmegen
European Organisation for Research and Treatment of Cancer - EORTC
February 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP