Condition category
Cancer
Date applied
19/08/2002
Date assigned
19/08/2002
Last edited
11/07/2014
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
+44 (0) 20 7670 4723

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

PARMA

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

Hospitals

Trial type

Not Specified

Patient information sheet

Condition

Lymphoma (non-Hodgkin's)

Intervention

Following registration all patients receive two courses of chemotherapy with dexamethasone, cisplatin and cytarabine (DHAP).

Patients who meet all the eligibility criteria and who have shown a response to initial treatment are randomised to either:
1. Regimen A: Involved field radiotherapy, 26 Gy in twenty fractions of 1.3 Gy. Radiotherapy to be given twice daily. Following radiotherapy patients receive chemotherapy carmustine, etoposide, cytarabine and cyclophosphamide (BEAC) and ABMT.
2. Regimen B: Four further courses of DHAP chemotherapy followed by involved field radiotherapy, 35 Gy in twenty fractions, to all sites of initial bulky disease.

Intervention type

Drug

Phase

Not Specified

Drug names

Dexamethasone, cisplatin, cytarabine

Primary outcome measures

Not provided at time of registration

Secondary outcome measures

Not provided at time of registration

Overall trial start date

01/01/1990

Overall trial end date

30/06/1994

Reason abandoned

Eligibility

Participant inclusion criteria

1. Aged 16 to 60 years
2. Relapsed intermediate and high grade lymphoma
3. Patients must have previously been treated with an adriamycin-containing regimen or COM or COMLA
4. No central nervous system (CNS) or bone marrow involvement at relapse
5. Patients must have previously reached a first complete remission on induction regimen
6. Only first and second relapse patients are eligible

Participant type

Patient

Age group

Adult

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

01/01/1990

Recruitment end date

30/06/1994

Locations

Countries of recruitment

United Kingdom

Trial participating centre

UKCCCR Register Co-ordinator
London
NW1 2DA
United Kingdom

Sponsor information

Organisation

Cancer Research UK (CRUK) (UK)

Sponsor details

PO Box 123
Lincoln's Inn Fields
London
WC2A 3PX
United Kingdom
+44 (0)207 317 5186
kate.law@cancer.org.uk

Sponsor type

Charity

Website

http://www.cancer.org.uk

Funders

Funder type

Charity

Funder name

Cancer Research UK (CRUK) (UK)

Alternative name(s)

CRUK

Funding Body Type

private sector organisation

Funding Body Subtype

other non-profit

Location

United Kingdom

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

Publication citations

Additional files

Editorial Notes