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

Phase 3

Completed

• Conditions: Hodgkin's Disease; Cancer

• Registration Number: ISRCTN99811594
• Lead Sponsor: eukaemia Research Fund (UK)

Brief Summary

2015 Results article in https://www.ncbi.nlm.nih.gov/pubmed/25901426 results (added 14/02/2020)

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2003-10-21
• Study Completion: 2009-12-31
• Last Update Posted: 7 November 2022

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 571

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

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

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<br> Added 05/01/2009:<br> Three-year progression-free survival.<br>

Secondary Outcome Measures

Name	Time	Method
<br> Added 05/01/2009:<br> 1. Incidence of FDG-PET positivity/negativity after three cycles of ABVD<br> 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.<br> 3. Incidence and type of second cancers. Participants will be followed up until death.<br>