Condition category
Cancer
Date applied
20/10/2003
Date assigned
21/10/2003
Last edited
11/06/2014
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Contact information

Type

Scientific

Primary contact

Ms Bilyana Popova

ORCID ID

Contact details

Cancer Research UK and UCL Cancer Trials Centre
90 Tottenham Court Road
London
W1T 4TJ
United Kingdom
fdg-pet@ctc.ucl.ac.uk

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

LRF 02/20

Study information

Scientific title

A randomised phase III trial to determine the role of FluoroDeoxyGlucose-Positron Emission Tomography imaging in clinical stages Ia/IIa Hodgkin's disease

Acronym

FDG-PET

Study hypothesis

Added 06/01/2009:
FluoroDeoxyGlucose-Positron Emission Tomography (FDG-PET) negativity after three cycles of adriamycin (doxorubicin), bleomycin, vinblastine and dacarbazine (ABVD) is indicative of a level of response whereby radiotherapy can be safely omitted without significantly compromising the duration of remission for patients with stage Ia/IIa Hodgkin's disease above the diaphragm.

On 05/01/2009 the following changes were made to this trial record:
1. The anticipated end date was changed from 01/10/2003 to 31/12/2009 (correction)
2. The target number of participants was changed from 320 to 400. An ethics approval has been obtained for this amendment.

Other changes are recorded within the relevant fields.

Ethics approval

North West Research Ethics Committee, 04/07/2003, ref: 03/8/056. An amendment to the number of participants was approved on 08/08/2008.

Study design

Randomised controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

Not available in web format, please use the contact details below to request a patient information sheet

Condition

Hodgkin's Disease

Intervention

Patients with a negative PET scan after three cycles of ABVD treatment will be randomised to involved field radiotherapy or no further treatment.

Intervention type

Drug

Phase

Phase III

Drug names

Adriamycin (doxorubicin), bleomycin, vinblastine and dacarbazine (ABVD)

Primary outcome measures

Added 05/01/2009:
Three-year progression-free survival.

Secondary outcome measures

Added 05/01/2009:
1. Incidence of FDG-PET positivity/negativity after three cycles of ABVD
2. Survival (time from date of registration/randomisation to date of death from any cause) and cause of death. Participants will be followed up until death.
3. Incidence and type of second cancers. Participants will be followed up until death.

Overall trial start date

01/10/2003

Overall trial end date

31/12/2009

Reason abandoned

Eligibility

Participant inclusion criteria

1. Aged 16 - 75 years, either sex
2. Histologically confirmed Hodgkin's disease (histology will be reviewed retrospectively by Professor A Jack at the Haematological Malignancy Diagnostic Service in Leeds but please note that this is not required before trial entry)
3. Clinical stages Ia/IIa above the diaphragm with no mediastinal bulk (defined as maximum transverse diameter of mediastinal mass: internal thoracic diameter at level of D5/6 interspace greater than 0.33). Bulky disease at other sites (defined as nodal mass with transverse diameter greater than 10 cm) is acceptable.
4. No previous treatment for Hodgkin's disease
5. No previous malignancy excepting appropriately treated basal cell carcinoma of the skin or carcinoma in situ of the cervix
6. No contraindications to chemotherapy or radiotherapy
7. Patients with reproductive potential: a willingness to use contraception from entry into the study for a period of 6 months
8. Written informed consent

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

400

Participant exclusion criteria

1. Patients with clinical stage Ia Hodgkin's disease with no clinical or computed tomography (CT) evidence of disease after diagnostic biopsy
2. Pregnant or lactating women
3. Severe underlying illness considered likely to make the trial therapy hazardous (for example severe heart disease or lung fibrosis)
4. Patients unwilling to travel to the nearest PET Centre
5. Patients unable to comply with follow-up arrangements

Recruitment start date

01/10/2003

Recruitment end date

31/12/2009

Locations

Countries of recruitment

United Kingdom

Trial participating centre

Cancer Research UK and UCL Cancer Trials Centre
London
W1T 4TJ
United Kingdom

Sponsor information

Organisation

Leukaemia Research Fund (UK)

Sponsor details

43 Great Ormond Street
London
WC1N 3JJ
United Kingdom
sgerscher@lrf.org.uk

Sponsor type

Charity

Website

http://www.lrf.org.uk

Funders

Funder type

Charity

Funder name

Leukaemia Research Fund (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

Publication citations

Additional files

Editorial Notes