Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
ECUP
Study information
Scientific title
Acronym
Study hypothesis
Not provided at time of registration
Ethics approval
Not provided at time of registration
Study design
Randomised controlled trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Not specified
Trial type
Not Specified
Patient information sheet
Not available in web format, please use the contact details below to request a patient information sheet
Condition
Lymphoma (non-Hodgkin's)
Intervention
Following registration all patients receive three, 3 week, cycles of chemotherapy with cyclophosphamide, adriamycin, vincristine and prednisone (CHOP).
Patients who achieve a complete or partial response are randomised to one of three treatment groups:
1. Group A: Chemotherapy, three further cycles of CHOP.
2. Group B High dose therapy with cyclophosphamide and total body irradiation, 8 Gy or 12 Gy midplane dose in a single fraction at a dose rate of 0.15-0.3 Gy/min, followed by unpurged ABMT.
3. Group C: High dose therapy with cyclophosphamide and total body irradiation, 8 Gy or 12 Gy midplane dose in a single fraction at a dose rate of 0.15-0.3 Gy/min, followed by purged ABMT.
Randomisation to Group A is optional. Prior to randomisation clinicians must choose to randomise between all treatment or Group 2 and Group 3 only.
Intervention type
Other
Phase
Not Specified
Drug names
Primary outcome measures
Not provided at time of registration
Secondary outcome measures
Not provided at time of registration
Overall trial start date
30/04/1992
Overall trial end date
30/04/1997
Reason abandoned
Eligibility
Participant inclusion criteria
1. Relapsed follicular non-Hodgkin's lymphoma, after a first or subsequent remission, requiring therapy because of at least one of the following:
1.1. B symptoms
1.2. Rapidly progressive disease
1.3. Bone marrow failure
1.4. Life threatening organ failure
2. Aged 15 - 65 years
3. No central nervous system (CNS) involvement
4. No previous radiotherapy greater than 2000 cGy to the mediastinum or abdomen, precluding total body irradiation
5. No previous myeloablative therapy
6. No prior malignancies, except non-melanomatous skin cancer or cervical carcinoma stage I
7. Adequate cardiac, neurologic, liver and renal function
8. No evidence of histlogically proven transformation
Participant type
Patient
Age group
Not Specified
Gender
Not Specified
Target number of participants
Not provided at time of registration
Participant exclusion criteria
Not provided at time of registration
Recruitment start date
30/04/1992
Recruitment end date
30/04/1997
Locations
Countries of recruitment
United Kingdom
Trial participating centre
UKCCCR Register Co-ordinator
London
NW1 2DA
United Kingdom
Sponsor information
Organisation
Baxter AG (Switzerland)
Sponsor details
Mullenrenstrasse 3
Volketswil
CH-8604
Switzerland
Sponsor type
Industry
Website
Funders
Funder type
Industry
Funder name
Baxter Healthcare (UK)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Results - basic reporting
Publication summary
2000 results in: http://www.ncbi.nlm.nih.gov/pubmed/10707787
Publication citations
-
Results
Schouten HC, Kvaloy S, Sydes M, Qian W, Fayers PM, The CUP trial: a randomized study analyzing the efficacy of high dose therapy and purging in low-grade non-Hodgkin's lymphoma (NHL)., Ann. Oncol., 2000, 11 Suppl 1, 91-94.