Condition category
Cancer
Date applied
19/08/2002
Date assigned
19/08/2002
Last edited
07/04/2010
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

EORTC 20981

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

Condition

Lymphoma (non-Hodgkin's)

Intervention

Arm 1: CHOP will be given at 3-week intervals. After three cycles patients will be evaluated for response. Patients with stable or progressive disease will go off study. A total of six cycles will be given.

Arm 2: CHOP plus Mabthera. Mabthera (iv) given on first day of each cycle of CHOP. Stable or progressive patients after three cycles will go off the study. A total of six cycles will be given.

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

11/11/1998

Overall trial end date

11/11/2005

Reason abandoned

Eligibility

Participant inclusion criteria

1. Patients with Ann Arbour stages III or IV follicular NHL (at initial diagnosis) who have relapsed after a minimum of two adequate non-anthracycline containing systemic chemotherapy regimens. Patients pre-treated with other chemotherapy regimens are not eligible for this trial.
2. Patients should have achieved remission on at least one of the prior regimens (i.e. either on the first or second regimen)
3. Remission duration upon one of the prior regimens should have been at least 3 months
4. Previous treatment should have been at least 4 month of single agent therapy (e.g. chlorambucil) and/or at least four consecutive cycles of polychemotherapy (e.g. CVP) or purine analogues. Patients treated with chemotherapy not fulfilling these criteria are not eligible.
5. Follicular NHL according to the Revised European/American Lymphoma (REAL) classification, i.e. follicle centre lymphoma, follicular (provisional cytological grades I [small cell], II [mixed small cell and large cell], III [large cell])
6. Must be CD20 positive lymphoma
7. At least one mass should be present measurable by two perpendicular diameters by either physical or radiological examination
8. Aged 18 years or above
9. World Health Organization (WHO) performance status 0, 1 or 2
10. Patient information and written informed consent according to the rules of the respective country

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

465

Participant exclusion criteria

Does not match inclusion criteria

Recruitment start date

11/11/1998

Recruitment end date

11/11/2005

Locations

Countries of recruitment

Australia, Belgium, Canada, Denmark, Egypt, France, Hungary, Italy, Netherlands, New Zealand, Norway, Poland, Slovakia, Slovenia, South Africa, Sweden, Switzerland, United Kingdom

Trial participating centre

UKCCCR Register Co-ordinator
London
NW1 2DA
United Kingdom

Sponsor information

Organisation

European Organisation for Research and Treatment of Cancer (EORTC) (Belgium)

Sponsor details

83
Avenue E. Mounier
Bte 11
Brussels
B-1200
Belgium
+32 (0)2 774 16 41
eortc@eortc.be

Sponsor type

Research organisation

Website

http://www.eortc.be

Funders

Funder type

Research organisation

Funder name

European Organisation for Research and Treatment of Cancer (EORTC) (Belgium)

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

2010 results in http://www.ncbi.nlm.nih.gov/pubmed/20368567

Publication citations

  1. Results

    van Oers MH, Tönnissen E, Van Glabbeke M, Giurgea L, Jansen JH, Klasa R, Marcus RE, Wolf M, Kimby E, Vranovsky A, Holte H, Hagenbeek A, van der Reijden BA, BCL-2/IgH polymerase chain reaction status at the end of induction treatment is not predictive for progression-free survival in relapsed/resistant follicular lymphoma: results of a prospective randomized EORTC 20981 phase III intergroup study., J. Clin. Oncol., 2010, 28, 13, 2246-2252, doi: 10.1200/JCO.2009.25.0852.

Additional files

Editorial Notes