Combination Chemotherapy in Treating Patients With Advanced Hodgkin's Disease
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| ClinicalTrials.gov Identifier: NCT00003421 |
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Recruitment Status :
Completed
First Posted : March 12, 2004
Last Update Posted : December 4, 2013
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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.
| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Lymphoma | Biological: bleomycin sulfate Drug: ABVD regimen Drug: chlorambucil Drug: dacarbazine Drug: doxorubicin hydrochloride Drug: etoposide Drug: prednisolone Drug: procarbazine hydrochloride Drug: vinblastine sulfate Drug: vincristine sulfate Radiation: radiation therapy | Phase 3 |
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.
| Study Type : | Interventional (Clinical Trial) |
| Estimated Enrollment : | 800 participants |
| Allocation: | Randomized |
| Primary Purpose: | Treatment |
| Official Title: | A UKLG Randomised Trial of Initial Chemotherapy for Advanced Stage Hodgkins Disease |
| Study Start Date : | June 1998 |
| Actual Study Completion Date : | November 2005 |
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| Ages Eligible for Study: | Child, Adult, Older Adult |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
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
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00003421
| United Kingdom | |
| St. James's Hospital | |
| Leeds, England, United Kingdom, LS9 7TF | |
| Weston Park Hospital | |
| Sheffield, England, United Kingdom, S1O 2SJ | |
| Study Chair: | Barry W. Hancock, MD | Cancer Research Centre at Weston Park Hospital |
| ClinicalTrials.gov Identifier: | NCT00003421 |
| Other Study ID Numbers: |
CDR0000066441 MRC-UKLG-LY09 EU-98020 |
| First Posted: | March 12, 2004 Key Record Dates |
| Last Update Posted: | December 4, 2013 |
| Last Verified: | May 2007 |
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stage I adult Hodgkin lymphoma stage II adult Hodgkin lymphoma stage III adult Hodgkin lymphoma stage IV adult Hodgkin lymphoma |
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Lymphoma Hodgkin Disease Neoplasms by Histologic Type Neoplasms Lymphoproliferative Disorders Lymphatic Diseases Immunoproliferative Disorders Immune System Diseases Prednisolone Doxorubicin Liposomal doxorubicin Bleomycin Etoposide Vincristine Dacarbazine |
Vinblastine Procarbazine Chlorambucil Antibiotics, Antineoplastic Antineoplastic Agents Topoisomerase II Inhibitors Topoisomerase Inhibitors Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action Antineoplastic Agents, Phytogenic Tubulin Modulators Antimitotic Agents Mitosis Modulators Anti-Inflammatory Agents Glucocorticoids |