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 |
| Protocol serial number | ECUP |
| Sponsor | Baxter AG (Switzerland) |
| Funder | Baxter Healthcare (UK) |
- 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
Scientific
UKCCCR Register Co-ordinator
MRC Clinical Trials Unit
222 Euston Road
London
NW1 2DA
United Kingdom
Study information
| Primary study design | Interventional |
|---|---|
| Study design | Randomised controlled trial |
| Secondary study design | Randomised controlled trial |
| Study type | Participant 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(s) |
Not provided at time of registration |
| Key secondary outcome measure(s) |
Not provided at time of registration |
| Completion date | 30/04/1997 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Not Specified |
| Sex | Not Specified |
| 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
- United Kingdom
- England
Study participating centre
UKCCCR Register Co-ordinator
London
NW1 2DA
United Kingdom
NW1 2DA
United Kingdom
Results and Publications
| Individual participant data (IPD) Intention to share | No |
|---|---|
| IPD sharing plan summary | 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 | |
| Participant information sheet | Participant information sheet | 11/11/2025 | 11/11/2025 | No | Yes |
