The role of FluoroDeoxyGlucose-Positron Emission Tomography imaging in clinical stages Ia/IIa Hodgkin's disease

ISRCTN	ISRCTN99811594
DOI	https://doi.org/10.1186/ISRCTN99811594
ClinicalTrials.gov number	NCT00943423
Secondary identifying numbers	LRF 02/20

Submission date: 20/10/2003
Registration date: 21/10/2003
Last edited: 26/10/2022

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Cancer

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English summary of protocol

https://www.cancerresearchuk.org/about-cancer/find-a-clinical-trial/a-trial-using-pet-scans-to-help-decide-treatment-options-for-early-stage-hodgkins-lymphoma

Contact information

Ms Bilyana Popova
Scientific

Cancer Research UK and UCL Cancer Trials Centre
90 Tottenham Court Road
London
W1T 4TJ
United Kingdom

Email	fdg-pet@ctc.ucl.ac.uk

Study information

Study design	Randomised controlled trial
Primary study design	Interventional
Secondary study design	Randomised controlled trial
Study setting(s)	Hospital
Study type	Treatment
Participant information sheet	Not available in web format, please use the contact details below to request a patient information sheet
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
Study acronym	FDG-PET
Study objectives	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(s)	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.
Health condition(s) or problem(s) studied	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
Pharmaceutical study type(s)
Phase	Phase III
Drug / device / biological / vaccine name(s)	Adriamycin (doxorubicin), bleomycin, vinblastine and dacarbazine (ABVD)
Primary outcome measure	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 study start date	01/10/2003
Completion date	31/12/2009

Eligibility

Participant type(s)	Patient
Age group	Adult
Sex	Both
Target number of participants	400
Total final enrolment	571
Key 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
Key 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
Date of first enrolment	01/10/2003
Date of final enrolment	31/12/2009

Locations

Countries of recruitment

England
United Kingdom

Study participating centre

Cancer Research UK and UCL Cancer Trials Centre

London
W1T 4TJ
United Kingdom

Sponsor information

Leukaemia Research Fund (UK)
Charity

43 Great Ormond Street
London
WC1N 3JJ
United Kingdom

Email	sgerscher@lrf.org.uk
Website	http://www.lrf.org.uk
"ROR"	https://ror.org/0055acf80

Funders

Funder type

Charity

Leukaemia Research Fund (UK)

No information available

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
Publication and dissemination plan	Not provided at time of registration
IPD sharing plan	Not provided at time of registration

Study outputs

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Results article	results	23/04/2015	14/02/2020	Yes	No
Plain English results			26/10/2022	No	Yes

Editorial Notes

25/10/2022: Cancer Research UK plain English results link and total final enrolment added.
14/02/2020: ClinicalTrials.gov number and publication reference added.
20/03/2017: No publications found in PubMed, verifying study status with principal investigator.