Condition category
Cancer
Date applied
19/08/2002
Date assigned
19/08/2002
Last edited
14/07/2014
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Dr - -

ORCID ID

Contact details

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

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

http://www.baxter.ch

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

  1. 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.

Additional files

Editorial Notes