The European CUP trial: a randomised trial in adults with poor risk relapsed follicular non-hodgkin's lymphoma

ISRCTN	ISRCTN46399359
DOI	https://doi.org/10.1186/ISRCTN46399359
Secondary identifying numbers	ECUP

Submission date: 19/08/2002
Registration date: 19/08/2002
Last edited: 14/07/2014

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Cancer

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English summary of protocol

Not provided at time of registration

Contact information

Dr - -
Scientific

UKCCCR Register Co-ordinator
MRC Clinical Trials Unit
222 Euston Road
London
NW1 2DA
United Kingdom

Study information

Study design	Randomised controlled trial
Primary study design	Interventional
Secondary study design	Randomised controlled trial
Study setting(s)	Not specified
Study type	Not Specified
Participant information sheet	Not available in web format, please use the contact details below to request a patient information sheet
Scientific title
Study objectives	Not provided at time of registration
Ethics approval(s)	Not provided at time of registration
Health condition(s) or problem(s) studied	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
Primary outcome measure	Not provided at time of registration
Secondary outcome measures	Not provided at time of registration
Overall study start date	30/04/1992
Completion date	30/04/1997

Eligibility

Participant type(s)	Patient
Age group	Not Specified
Sex	Not Specified
Target number of participants	Not provided at time of registration
Key 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
Key exclusion criteria	Not provided at time of registration
Date of first enrolment	30/04/1992
Date of final enrolment	30/04/1997

Locations

Countries of recruitment

England
United Kingdom

Study participating centre

UKCCCR Register Co-ordinator

London
NW1 2DA
United Kingdom

Sponsor information

Baxter AG (Switzerland)
Industry

Mullenrenstrasse 3
Volketswil
CH-8604
Switzerland

Website	http://www.baxter.ch
"ROR"	https://ror.org/052wab383

Funders

Funder type

Industry

Baxter Healthcare (UK)

No information available

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
Publication and dissemination plan	Not provided at time of registration
IPD sharing plan

Study outputs

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Results article	results	01/03/2000		Yes	No