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Combination Chemotherapy in Treating Patients With Advanced Hodgkin's Disease

A UKLG Randomised Trial of Initial Chemotherapy for Advanced Stage Hodgkins Disease

Status
Completed
Phases
Phase 3
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00003421
Enrollment
800
Registered
2004-03-12
Start date
1998-06-30
Completion date
2005-11-30
Last updated
2013-12-04

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Lymphoma

Keywords

stage I adult Hodgkin lymphoma, stage II adult Hodgkin lymphoma, stage III adult Hodgkin lymphoma, stage IV adult Hodgkin lymphoma

Brief summary

RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining more than one drug may kill more tumor cells. It is not yet known which chemotherapy regimen is more effective for advanced Hodgkin's disease. PURPOSE: Randomized phase III trial to compare different combination chemotherapy regimens in treating patients with advanced Hodgkin's disease.

Detailed description

OBJECTIVES: I. Determine whether a four-drug anthracycline-based regimen or a seven-drug hybrid or eight-drug alternating regimen is the optimal treatment for patients with advanced Hodgkin's disease. OUTLINE: This is a randomized study. Patients are randomized to one of two treatment arms. Arm I (ABVD): Patients receive doxorubicin IV, bleomycin IV, vinblastine IV, and dacarbazine IV on days 1 and 15. Courses repeat every 4 weeks. Arm II (ChlVPP/PABLOE): Patients receive oral chlorambucil, procarbazine, and prednisolone on days 1-14; vinblastine IV on days 1 and 8; doxorubicin IV on day 29; vincristine IV and bleomycin IV on days 29 and 36; oral etoposide on days 29-31; and oral prednisolone again on days 29-38. Courses repeat every 7 weeks. OR (Hybrid - ChlVPP/EVA): Patients receive vincristine IV on day 1; oral etoposide on days 1-5; oral chlorambucil, procarbazine, and prednisolone on days 1-7; and doxorubicin IV and vinblastine IV on day 8. Courses repeat every 4 weeks. Patients in both arms receive up to 6-8 courses of treatment. Radiotherapy may be given to sites of previous bulk disease for patients in complete remission or uncertain remission. Patients who achieve partial remission may receive radiotherapy to residual disease sites. Patients who fail to respond, or have disease progression, may receive induction therapy followed by high-dose consolidation therapy. Patients are followed every 3 months for 2 years, every 6 months for 5 years, and then annually for 5 years. PROJECTED ACCRUAL: Approximately 800 patients will be accrued for this study.

Interventions

RADIATIONradiation therapy
BIOLOGICALbleomycin sulfate
DRUGchlorambucil
DRUGdacarbazine
DRUGdoxorubicin hydrochloride
DRUGetoposide
DRUGprednisolone
DRUGprocarbazine hydrochloride
DRUGvinblastine sulfate
DRUGvincristine sulfate

Sponsors

Medical Research Council
Lead SponsorOTHER_GOV

Study design

Allocation
RANDOMIZED
Primary purpose
TREATMENT

Eligibility

Sex/Gender
ALL
Healthy volunteers
No

Inclusion criteria

DISEASE CHARACTERISTICS: Histologically confirmed advanced Hodgkin's disease requiring systemic therapy Stage IA or IIA disease with bulky disease or more than three sites of involvement are also eligible PATIENT CHARACTERISTICS: Age: Not specified Performance status: Not specified Hematopoietic: Not specified Hepatic: Not specified Renal: Not specified Other: No other active malignancy within 5 years HIV negative Not pregnant or nursing Fertile patients must use effective contraception PRIOR CONCURRENT THERAPY: Biologic therapy: Not specified Chemotherapy: No prior chemotherapy for Hodgkin's disease Endocrine therapy: Not specified Radiotherapy: No prior radiotherapy for Hodgkin's disease Surgery: Not specified

Countries

United Kingdom

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026