Combination Chemotherapy in Treating Patients With Previously Untreated Advanced Hodgkin's Lymphoma
NCT ID: NCT00041210
Last Updated: 2013-09-20
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE3
850 participants
INTERVENTIONAL
2001-10-31
Brief Summary
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PURPOSE: Randomized phase III trial to compare the effectiveness of two different combination chemotherapy regimens in treating patients who have advanced Hodgkin's lymphoma.
Detailed Description
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* Compare relapse-free and overall survival of patients with previously untreated advanced Hodgkin's lymphoma treated with bleomycin, doxorubicin, etoposide, mechlorethamine, vinblastine, vincristine, and prednisone (Stanford V) vs doxorubicin, bleomycin, vinblastine, and dacarbazine (ABVD).
* Compare the toxicity of these regimens in these patients.
OUTLINE: This is a randomized, multicenter study. Patients are randomized to 1 of 2 treatment arms.
* Arm I (Stanford V): Patients receive mechlorethamine on weeks 1, 5, and 9; vinblastine and doxorubicin on weeks 1, 3, 5, 7, 9, and 11; etoposide IV over 30-45 minutes for 2 consecutive days on weeks 3, 7, and 11; and vincristine and bleomycin on weeks 2, 4, 6, 8, 10, and 12. Patients also receive oral prednisone every other day on days 1-63 followed by a taper on days 64-84. Treatment continues for 12 weeks.
* Arm II (ABVD): Patients receive doxorubicin, bleomycin, vinblastine, and dacarbazine on days 1 and 15. Treatment repeats every 28 days for 6-8 courses.
All patients achieving a complete remission or partial remission after chemotherapy undergo involved field radiotherapy if they had initial bulky mediastinal disease, initial nodal masses at least 5 cm in diameter, or initial splenic disease.
Patients are followed every 3 months for 1 year, every 4 months for 1 year, every 6 months for 3 years, and then annually thereafter.
Peer Reviewed and Funded or Endorsed by Cancer Research UK
PROJECTED ACCRUAL: Approximately 700-850 patients will be accrued for this study.
Conditions
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Keywords
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Study Design
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RANDOMIZED
TREATMENT
Interventions
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bleomycin sulfate
ABVD regimen
Stanford V regimen
dacarbazine
doxorubicin hydrochloride
etoposide
mechlorethamine hydrochloride
prednisone
vinblastine sulfate
vincristine sulfate
radiation therapy
Eligibility Criteria
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Inclusion Criteria
* Histologically confirmed Hodgkin's lymphoma (any sub-type)
* Stage IB, IIB, IIIA, IIIB, or IV OR
* Stage IA or IIA with locally extensive disease (e.g., bulky mediastinal disease (e.g., greater than 0.33 of the maximum transthoracic diameter on routine chest X-ray or at least 2 extranodal sites of disease))
PATIENT CHARACTERISTICS:
Age:
* 18 to 60
Performance status:
* Not specified
Life expectancy:
* Not specified
Hematopoietic:
* Complete blood count normal unless directly due to Hodgkin's lymphoma
Hepatic:
* Hepatic function normal unless directly due to Hodgkin's lymphoma
Renal:
* Renal function normal unless directly due to Hodgkin's lymphoma
Cardiovascular:
* No pre-existing cardiac disease
Pulmonary:
* No pre-existing pulmonary disease
Other:
* Not pregnant
* Fertile patients must use effective contraception during and for six months after study
* HIV negative
* No other prior malignancy except basal cell or squamous cell skin cancer
PRIOR CONCURRENT THERAPY:
Biologic therapy:
* Not specified
Chemotherapy:
* Not specified
Endocrine therapy:
* Not specified
Radiotherapy:
* Not specified
Surgery:
* Not specified
Other:
* No prior therapy for Hodgkin's lymphoma
18 Years
60 Years
ALL
No
Sponsors
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Mount Vernon Cancer Centre at Mount Vernon Hospital
OTHER
Principal Investigators
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Peter J. Hoskin, MD
Role: STUDY_CHAIR
Mount Vernon Cancer Centre at Mount Vernon Hospital
Locations
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Basildon University Hospital
Basildon, England, United Kingdom
Royal United Hospital
Bath, England, United Kingdom
Kent and Canterbury Hospital
Canterbury, England, United Kingdom
Saint Richards Hospital
Chichester, England, United Kingdom
Walsgrave Hospital
Coventry, England, United Kingdom
Doncaster Royal Infirmary
Doncaster, England, United Kingdom
Russells Hall Hospital
Dudley, England, United Kingdom
Royal Devon and Exeter Hospital
Exeter, England, United Kingdom
Hemel Hempstead General
Hemel Hempstead, England, United Kingdom
Hull Royal Infirmary
Hull, England, United Kingdom
King George Hospital
Ilford, Essex, England, United Kingdom
Lincoln County Hospital
Lincoln, England, United Kingdom
Royal Liverpool University Hospital
Liverpool, England, United Kingdom
Aintree University Hospital
Liverpool, England, United Kingdom
Saint Bartholomew's Hospital
London, England, United Kingdom
St. George's Hospital
London, England, United Kingdom
University College Hospital - London
London, England, United Kingdom
James Paget Hospital
Norfolk, England, United Kingdom
Mount Vernon Cancer Centre at Mount Vernon Hospital
Northwood, England, United Kingdom
Nottingham City Hospital NHS Trust
Nottingham, England, United Kingdom
Derriford Hospital
Plymouth, England, United Kingdom
Portsmouth Oncology Centre at Saint Mary's Hospital
Portsmouth Hants, England, United Kingdom
Oldchurch Hospital
Romford, England, United Kingdom
Cancer Research Centre at Weston Park Hospital
Sheffield, England, United Kingdom
Southampton General Hospital
Southampton, England, United Kingdom
Staffordshire General Hospital
Stafford, England, United Kingdom
Royal Marsden - Surrey
Sutton, England, United Kingdom
Torbay Hospital
Torquay, England, United Kingdom
City Hospital - Birmingham
West Bromwich, England, United Kingdom
New Cross Hospital
Wolverhampton, England, United Kingdom
Worthing Hospital
Worthing, England, United Kingdom
Cancer Care Centre at York Hospital
York, England, United Kingdom
Craigavon Area Hospital
Craigavon, Northern Ireland, United Kingdom
Monklands General Hospital
Airdrie, Scotland, United Kingdom
Pinderfields General Hospital
Wakefield, Scotland, United Kingdom
Velindre Cancer Center at Velindre Hospital
Cardiff, Wales, United Kingdom
South West Wales Cancer Institute
Swansea, Wales, United Kingdom
Countries
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Other Identifiers
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BNLI-STANFORDV
Identifier Type: -
Identifier Source: secondary_id
EU-20206
Identifier Type: -
Identifier Source: secondary_id
CDR0000069453
Identifier Type: -
Identifier Source: org_study_id