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NB: The information displayed below does not replace the protocol. The latest protocol version should always be consulted before making clinical decisions.
RAPID (formerly PET Trial in Hodgkin's Disease)

A randomised Phase III trial to determine the role of FDG-PET Imaging in Clinical Stages IA/IIA Hodgkin's Disease.

Specialty
Cancer
Portfolio Eligibility
Automatically eligible
ISRCTN 99811594
EudraCT
MREC N° 03/8/056
UKCRN ID 1299
WHO ID
Research Summary
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. Please note that the following changes have been made to this ISRCTN record as of 05/01/2009: 1. The anticipated end date of this trial has been 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 recored within the relevant fields.
Study Type Interventional
Design Type Screening
Disease(s) Lymphoma (Hodgkin's)
Phase III
Current Status Closed - follow-up complete
Closure Date 8/3/2010
Global Sample Size 600
Global Recruitment to Date
100%
Geographical Scope UK Multi-Centre
Lead Country England (also active in Scotland and Northern Ireland and Wales)
Health care professionals can obtain a copy of the protocol by clicking here
Additional Information

If you are a patient or relative this link will take you to a description of the trial in plain English on CancerHelp UK.

Main Inclusion Criteria
1] Age 16-75 years
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 >0.33.). Bulky disease at other sites (defined as nodal mass with transverse diameter >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
Main Exclusion Criteria
1] Patients with clinical stage IA Hodgkin’s disease with no clinical or 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 as defined in section 14 of this protocol.
Chief Investigator(s)
Prof John Radford
Further details, please contact
Ms Bilyana Popova

UCL Cancer Institute
Cancer Research Uk & U C L Trials Centre
90 Tottenham Court Road
London
W1T 4TJ
UNITED KINGDOM

Tel: 0207 679 9860
b.popova@ctc.ucl.ac.uk
Funder(s) Leukaemia & Lymphoma Research
Sponsor(s) Christie Hospital NHS Foundation Trust




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