Plain English Summary
Trial website
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
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