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 designRandomised controlled trial
Primary study designInterventional
Secondary study designRandomised controlled trial
Study setting(s)Not specified
Study typeNot Specified
Participant information sheet Not available in web format, please use the contact details below to request a patient information sheet
Scientific title
Study objectivesNot provided at time of registration
Ethics approval(s)Not provided at time of registration
Health condition(s) or problem(s) studiedLymphoma (non-Hodgkin's)
InterventionFollowing 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 typeOther
Primary outcome measureNot provided at time of registration
Secondary outcome measuresNot provided at time of registration
Overall study start date30/04/1992
Completion date30/04/1997

Eligibility

Participant type(s)Patient
Age groupNot Specified
SexNot Specified
Target number of participantsNot provided at time of registration
Key inclusion criteria1. 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 criteriaNot provided at time of registration
Date of first enrolment30/04/1992
Date of final enrolment30/04/1997

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 logo "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 shareNo
IPD sharing plan summaryNot provided at time of registration
Publication and dissemination planNot 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