Trial Details
Trial status:
In follow-up (non-recruiting)
Recruitment start date:
28/08/2008
Funder:
Cancer Research UK
Sponsor:
UCL
Chief Investigator:
Professor Peter Johnson
Recruitment target:
1200
EudraCT number:
2007-006064-30
Contact details:
ctc.rathl@ucl.ac.uk
Lay summary:
RATHL
A randomised Phase III trial to assess response adapted therapy using FDG-PET imaging in patients with newly diagnosed, advanced Hodgkin Lymphoma
Description
Design: RATHL is a multi-centre randomised trial comparing treatment outcome for patients with advanced Hodgkin lymphoma, using FDG-PET imaging after 2 cycles of ABVD to determine response and subsequent management.
Treatment: All patients will receive 2 cycles of ABVD before randomisation.  Patients then have a PET-CT scan.  Patients with a negative result are randomised to receive either a further 4 cycles of ABVD or 4 cycles of AVD.  Patients with a positive result will receive either 4 cycles of BEACOPP-14 or 3 cycles of BEACOPP escalated (determined by the site at the beginning of the trial).   Patients who had a positive result at the 2nd PET-CT scan will have another PET-CT scan.  Patients with a negative result will receive a further 2 cycles of BEACOPP-14 or 1 cycle of BEACOPP escalated.  Patients with a positive result with receive radiotherapy or a salvage therapy determined by the investigator.  Patients are then followed up until death.
Key inclusion/exclusion criteria: Patients must be 18 or above and have histologically proven classical Hodgkin Lymphoma.  Patient must have stage IIB-IV disease or stage IIA with adverse features.  Patients ECOG performance status must be 0-3 and they must have adequate bone marrow function and neutrophils. Patients can’t have CNS involvement, HIV or serological evidence of active Hepatitis B or Hepatitis C infection.  Patients can’t have a cardiac contraindication to doxorubicin or neurological contraindication to chemotherapy.
Duration of recruitment: 3-4 years
Aim
The overall aim of this study is to evaluate prospectively the role of FDG-PET imaging after 2 cycles of ABVD chemotherapy in determining response assessment and subsequent management decisions for patients receiving first-line treatment for advanced Hodgkin lymphoma.
Trial protocols
Trial protocols must not be applied to patients treated outside trials. UCL CTC can only ensure that approved trial investigators are provided with amendments to protocols.
NameVersionCurrent versRelease dateDownload
Ovarian_substudy_Protocol_v1 4_16 02 12 (clean)_21062018_0.pdf1.4 Current 16/02/2012
RATHL protocol v5.1 20.09.13 (final)_21062018_0.pdf5.1 Current 20/09/2013
Trial documents
No documents have been currently made available for download
Contact Us
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