ISRCTN99811594
Completed
Phase 3
A randomised phase III trial to determine the role of FluoroDeoxyGlucose-Positron Emission Tomography imaging in clinical stages Ia/IIa Hodgkin's disease
eukaemia Research Fund (UK)0 sites571 target enrollmentOctober 21, 2003
Overview
- Phase
- Phase 3
- Intervention
- Not specified
- Conditions
- Not specified
- Sponsor
- eukaemia Research Fund (UK)
- Enrollment
- 571
- Status
- Completed
- Last Updated
- 3 years ago
Overview
Brief Summary
2015 Results article in https://www.ncbi.nlm.nih.gov/pubmed/25901426 results (added 14/02/2020)
Investigators
Eligibility Criteria
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
Outcomes
Primary Outcomes
Not specified
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