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ISRCTN
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ISRCTN55593137
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ClinicalTrials.gov identifier
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Public title
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A randomised trial of radiotherapy alone versus three cycles of cylophosphamide, doxorubicin, vincristine and prednisolone (CHOP) chemotherapy plus radiotherapy versus six cycles of CHOP chemotherapy plus radiotherapy for early stage aggressive non-Hodgkin's lymphoma
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Scientific title
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Acronym
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N/A
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Serial number at source
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LY05
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Study hypothesis
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Not provided at time of registration
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Ethics approval
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Not provided at time of registration
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Study design
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Randomised controlled trial
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Countries of recruitment
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United Kingdom
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Disease/condition/study domain
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Non-Hodgkin's lymphoma
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Participants - inclusion criteria
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1. Biopsy proven non-Hodgkin's lymphoma of any of the following histologies: International Working Formulation groups F, G and H; Kiel Classification: centroblastic B-cell, pleomorphic medium and large T-cell, immunoblastic, large cell anaplastic and high grade unclassified; Revised European-American Classification of Lymphoid Neoplasms (REAL Classification): Diffuse large B-cell, anaplastic large cell, high-grade B-cell or Mucosa-associated lymphoid tissue (MALT) type, and peripheral T-cell
2. WHO performance status 0, 1, 2
3. Aged greater than 15 years
4. No previous chemotherapy or radiotherapy 5. Normal lactic dehydrogenase (LDH)
6. Stage I, IE, II, IIE, except bulky abdominal presentation
7. No B symptoms
8. No previous malignancy, except basal cell carcinoma of the skin or cervical carcinoma stage I
9. No evidence of Human Immunodeficiency Virus (HIV) positively
10. No contraindications to protocol treatments
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Participants - exclusion criteria
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Patients with testicular, brain, gastrointestinal or skin primaries are excluded.
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Anticipated start date
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01/01/1990
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Anticipated end date
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31/10/1996
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Status of trial
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Completed
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Patient information material
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Target number of participants
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Not provided at time of registration
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Interventions
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Patients are randomised to one of three treatment regimens:
1. Regimen A: Radiotherapy 40 Gy in twenty to twenty-five fractions.
2. Regimen B: Chemotherapy with cylophosphamide, doxorubicin, vincristine and prednisolone (CHOP) repeated every 21 days for three cycles. Radiotherapy 30 Gy in fifteen fractions for patients in complete remission or 40 Gy in twenty to twenty-five fractions for patients who are not in chemotherapy induced complete remission.
3. Regimen B: Chemotherapy with cylophosphamide, doxorubicin, vincristine and prednisolone (CHOP) repeated every 21 days for six cycles. Radiotherapy 30 Gy in fifteen fractions for patients in complete remission or 40 Gy in twenty to twenty-five fractions for patients who are not in chemotherapy induced complete remission.
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Primary outcome measure(s)
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Not provided at time of registration
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Secondary outcome measure(s)
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Not provided at time of registration
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Sources of funding
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Cancer Research UK
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Trial website
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Publications
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Contact name
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Dr
-
-
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Address
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UKCCCR Register Co-ordinator
MRC Clinical Trials Unit
222 Euston Road
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City/town
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London
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Zip/Postcode
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NW1 2DA
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Country
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United Kingdom
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Tel
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+44 (0) 20 7670 4723
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Fax
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+44 (0) 20 7670 4818
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Email
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register@ctu.mrc.ac.uk
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Sponsor
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Cancer Research UK (CRUK) (UK)
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Address
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PO Box 123
Lincoln's Inn Fields
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City/town
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London
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Zip/Postcode
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WC2A 3PX
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Country
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United Kingdom
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Tel
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+44 (0)20 7317 5186
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Fax
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+44 (0)20 7487 4302
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Email
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kate.law@cancer.org.uk
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Sponsor website:
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http://www.cancer.org.uk
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Date applied
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01/07/2001
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Last edited
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23/05/2008
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Date ISRCTN assigned
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01/07/2001
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