Combination Chemotherapy Given With Radiation Therapy or Radiation Therapy Alone in Treating Patients With Early-Stage Hodgkin's Disease
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| ClinicalTrials.gov Identifier: NCT00002987 |
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Recruitment Status : Unknown
Verified March 2005 by National Cancer Institute (NCI).
Recruitment status was: Active, not recruiting
First Posted : April 6, 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 radiation therapy with chemotherapy may kill more tumor cells.
PURPOSE: Randomized phase III trial to compare the effectiveness of combination chemotherapy plus radiation therapy with radiation therapy alone in treating patients with early-stage Hodgkin's disease.
| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Lymphoma | Biological: bleomycin sulfate Drug: cyclophosphamide Drug: doxorubicin hydrochloride Drug: etoposide Drug: prednisolone Drug: vincristine sulfate Radiation: radiation therapy | Phase 3 |
OBJECTIVES: I. Determine the recurrence rate and long term survival of patients with early stage Hodgkin's disease given vincristine/doxorubicin/prednisolone/ etoposide/cyclophosphamide/bleomycin (VAPEC-B) chemotherapy and involved field radiation vs mantle radiotherapy.
OUTLINE: This is a randomized multicenter study. Patients are randomized to receive either vincristine/doxorubicin/prednisolone/etoposide/cyclophosphamide/ bleomycin (VAPEC-B) chemotherapy and involved field radiotherapy or mantle radiotherapy only. Patients receiving VAPEC-B are given prednisolone daily on weeks 1-6, doxorubicin IV along with cyclophosphamide IV on week 1, doxorubicin IV and etoposide orally for 5 days on week 3, and vincristine and bleomycin IV on weeks 2 and 4. Involved field radiotherapy is commenced at week 6, within 14 to 21 days of the last chemotherapy treatment. Patients randomized to receive mantle radiotherapy only are given treatments daily for 4 weeks. Patients are followed every 3 months for the first two years, every 4 months for the third year, every 6 months for the fourth and fifth years and annually thereafter.
PROJECTED ACCRUAL: 400 patients will be accrued over 4-5 years.
| Study Type : | Interventional (Clinical Trial) |
| Estimated Enrollment : | 400 participants |
| Primary Purpose: | Treatment |
| Official Title: | Minimal Initial Therapy (MIT) for "Early" Supradiaphragmatic Hodgkin's Disease: A Multicenter Randomized Trial of Short Neoadjuvant Chemotherapy (VAPEC-B) Plus Involved Field Radiotherapy (MIT) Versus Mantle Radiotherapy |
| Study Start Date : | January 1997 |
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| Ages Eligible for Study: | 16 Years to 75 Years (Child, Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS: Histologically proven stage IA or IIA Hodgkin's disease without mediastinal bulk Patients with Hodgkin's disease existing below diaphragm only are not eligible
PATIENT CHARACTERISTICS: Age: 16 to 75 Performance status: Not specified Life expectancy: Not specified Hematopoietic: Not specified Hepatic: Not specified Renal: Not specified Other: Not HIV positive No prior malignancy other than basal cell carcinoma or cervical intraepithelial neoplasia
PRIOR CONCURRENT THERAPY: No prior treatment
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): NCT00002987
| South Africa | |
| Groote Schuur Hospital, Cape Town | |
| Cape Town, South Africa, 7925 | |
| United Kingdom | |
| University Birmingham | |
| Birmingham, England, United Kingdom, B15 2TT | |
| Bristol Royal Hospital for Sick Children | |
| Bristol, England, United Kingdom, BS2 8BJ | |
| Bristol Oncology Centre | |
| Bristol, England, United Kingdom, BS2 8ED | |
| Addenbrooke's NHS Trust | |
| Cambridge, England, United Kingdom, CB2 2QQ | |
| Derbyshire Royal Infirmary | |
| Derby, England, United Kingdom, DE1 2QY | |
| Cookridge Hospital | |
| Leeds, England, United Kingdom, LS16 6QB | |
| University Hospitals of Leicester | |
| Leicester, England, United Kingdom, LE1 5WW | |
| Middlesex Hospital- Meyerstein Institute | |
| London, England, United Kingdom, W1G 3AA | |
| Clatterbridge Centre for Oncology NHS Trust | |
| Merseyside, England, United Kingdom, L63 4JY | |
| Newcastle General Hospital | |
| Newcastle Upon Tyne, England, United Kingdom, NE4 6BE | |
| Mount Vernon Hospital | |
| Northwood, England, United Kingdom, HA6 2RN | |
| Norfolk & Norwich Hospital | |
| Norwich, England, United Kingdom, NR1 3SR | |
| Oxford Radcliffe Hospital | |
| Oxford, England, United Kingdom, 0X3 9DU | |
| Royal Marsden Hospital | |
| Sutton, England, United Kingdom, SM2 5PT | |
| Southend General Hospital | |
| Westcliff-On-Sea, England, United Kingdom | |
| Royal Hospital for Sick Children | |
| Edinburgh, Scotland, United Kingdom | |
| Royal Preston Hospital | |
| Preston, United Kingdom, PR2 9HT | |
| Study Chair: | Michael Williams, MD | Cambridge University Hospitals NHS Foundation Trust |
Publications of Results:
| ClinicalTrials.gov Identifier: | NCT00002987 History of Changes |
| Other Study ID Numbers: |
CDR0000065522 MRC-UKLG-LY07 EU-97004 |
| First Posted: | April 6, 2004 Key Record Dates |
| Last Update Posted: | December 4, 2013 |
| Last Verified: | March 2005 |
Keywords provided by National Cancer Institute (NCI):
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stage I adult Hodgkin lymphoma stage II adult Hodgkin lymphoma |
Additional relevant MeSH terms:
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Lymphoma Hodgkin Disease Neoplasms by Histologic Type Neoplasms Lymphoproliferative Disorders Lymphatic Diseases Immunoproliferative Disorders Immune System Diseases Cyclophosphamide Liposomal doxorubicin Doxorubicin Etoposide Vincristine Prednisolone Bleomycin |
Immunosuppressive Agents Immunologic Factors Physiological Effects of Drugs Antirheumatic Agents Antineoplastic Agents, Alkylating Alkylating Agents Molecular Mechanisms of Pharmacological Action Antineoplastic Agents Myeloablative Agonists Antibiotics, Antineoplastic Topoisomerase II Inhibitors Topoisomerase Inhibitors Enzyme Inhibitors Antineoplastic Agents, Phytogenic Tubulin Modulators |