Condition category
Cancer
Date applied
19/08/2002
Date assigned
19/08/2002
Last edited
19/01/2016
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

NCT00003152

Protocol/serial number

EORTC 20963

Study information

Scientific title

Marrow-ablative chemotherapy and autologous stem cell transplantation followed by interferon-alpha maintenance treatment versus interferon-alpha maintenance treatment alone for stage III and IV follicular Non-Hodgkin's lymphoma

Acronym

Study hypothesis

Added 07/08/09:
Interferon alpha may interfere with the growth of cancer cells. Radiation therapy uses high-energy x-rays to damage cancer cells. Peripheral stem cell transplantation may allow the doctor to give higher doses of chemotherapy drugs and radiation therapy and kill more cancer cells.
The aim of this trial is to compare the effectiveness of combination chemotherapy followed by interferon alfa alone versus combination chemotherapy plus radiation therapy and peripheral stem cell transplantation in treating patients who have previously untreated stage III or stage IV follicular non-Hodgkin's lymphoma.

As of 07/08/09 this record has been extensively updated. All updates can be found under the relevant field with the above update date. Please also note that the start date of this trial have been changed from 01/01/1999 as this date was automatically generated on registration.

Ethics approval

Not provided at time of registration

Study design

Multicentre randomised active controlled parallel group trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

Condition

Lymphoma (non-Hodgkin's)

Intervention

1. All patients receive induction chemotherapy with cyclophosphamide, vincristine and prednisolone (CVP) repeated every 21 days for eight cycles.
2. Patients who achieve a complete remission or partial remission with a limited bone marrow infiltration will be randomised to one of the two arms of the protocol:
2.1. Arm A: Maintenance treatment with interferon-alpha, 3MU three times weekly until disease progression or relapse (a maximum period of three years).
2.2. Arm B: Patients receive cylophosphamide priming and peripheral blood stem cell harvest followed by marrow-ablative chemo-radiotherapy. Marrow-ablative chemo-radiotherapy consists of high-dose cyclophosphamide and total body irradiation at a total dose of 9 Gy to the midline of the body plus peripheral blood stem cell reinfusion. Maintenance treatment with interferon-alpha, 3MU three times weekly is given until disease progression or relapse (a maximum period of three years).

Intervention type

Drug

Phase

Phase III

Drug names

Cyclophosphamide, vincristine and prednisolone (CVP), interferon-alpha.

Primary outcome measures

Added 07/08/09:
1. Progression free and overall survival
2. Toxicity
3. Mortality
Patients are followed every 4 months until death.

Secondary outcome measures

Not provided at time of registration

Overall trial start date

28/03/1997

Overall trial end date

15/11/1999

Reason abandoned

Eligibility

Participant inclusion criteria

Current information as of 07/08/09:
1. Previously untreated follicular non-Hodgkin's lymphoma presenting with stages III or IV, including nodal, Waldeyers ring and extranodal locations - at least one measurable mass should be present
2. Above 18 years and below 66 years
3. World Health Organisation (WHO) performance status zero to two
4. Alkaline phosphatase and bilirubin less than 2.5 times upper limit of normal (ULN) (unless clearly related to NHL)
5. Creatinine and BUN less than 2.5 times ULN (unless clearly related to NHL)

Initial information at registration:
1. Previously untreated follicular non-Hodgkin's lymphoma presenting with stages III or IV, including nodal, Waldeyers ring and extranodal locations - at least one measurable mass should be present
2. Above 18 years and below 66 years
3. World Health Organisation (WHO) performance status zero to two

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

469 patients will be accrued for this study within 5 years (added 07/08/09)

Participant exclusion criteria

Current information as of 07/08/09:
1. Prior malignancies except non-melanoma skin tumours or stage 0 in situ cervical carcinoma
2. Severe cardiac disease (e.g. severe heart failure requiring treatment or cardiac ejection fraction less than 45%)
3. Neurologic disease
4. Pulmonary disease
5. Psychiatric or metabolic disease
6. HIV positive
7. Pregnancy
8. Other medical contraindications to protocol treatments

Initial information at registration
1. Prior malignancies except non-melanoma skin tumours or stage 0 in situ cervical carcinoma
2. Other medical contraindications to protocol treatments

Recruitment start date

28/03/1997

Recruitment end date

15/11/1999

Locations

Countries of recruitment

Netherlands, 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 2 774 16 41
eortc@eortc.be

Sponsor type

Research organisation

Website

http://www.eortc.be

Funders

Funder type

Research organisation

Funder name

Added 07/08/09:

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Funder name

European Organization for Research and Treatment of Cancer (EORTC) (ref: 20963)

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

Publication citations

Additional files

Editorial Notes