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RATHL

A randomised phase III trial to assess response adapted therapy using FDG-PET imaging in patients with newly diagnosed, advanced hodgkin lymphoma

Specialty
Cancer
Portfolio Eligibility
Automatically eligible
ISRCTN
EudraCT 2007-006064-30
MREC N° 108/H0504/15
UKCRN ID 4488
WHO ID
Research Summary
Study Type Interventional
Design Type Treatment
Disease(s) Lymphoma (Hodgkin's)
Phase III
Current Status Closed - in follow-up
Closure Date 12/21/2012
Global Sample Size 1200
Global Recruitment to Date
  71%
Geographical Scope International Multi-Centre
Lead Country England (also active in Scotland and Wales)
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. Histologically confirmed classical Hodgkin lymphoma (HL) according to the current World Health Organisation Classification (nodular sclerosis, mixed cellularity, lymphocyte rich, lymphocyte depleted). All histology will be reviewed by a central pathology panel for the group concerned.
2. Aged 18 or above
3. Clinical stage IIB, IIIA, IIIB or IV, or Clinical stage IIA with adverse features:
· bulk mediastinal disease, defined as maximal transverse diameter of mass >0.33 of the internal thoracic diameter at D5/6 interspace on routine chest X-ray
· outside the mediastinum, lymph node or lymph node mass greater than 10cm in diameter
· more than two sites of disease
· other poor risk features as a result of which it is considered necessary to treat with full course combination chemotherapy
4.No previous chemotherapy, radiotherapy or other investigational drug for HL.
5. Performance status 0-3 (Appendix 6).
6. Adequate bone marrow function with platelets > 100x109/l; neutrophils > 1.5x109/l at the time of study entry unless lower numbers are attributed to bone marrow infiltration by lymphoma
7. Serum creatinine less than 150% of the upper limit of normal, serum bilirubin less than twice the upper limit of normal and transaminases < 2.5x upper limit of normal unless attributed to lymphoma.
8. Patients with a significant history of ischaemic heart disease or hypertension must have an acceptable left ventricular ejection fraction (LVEF) >=50%.
9. Lung function tests showing diffusion capacity within 25% of normal predicted value for the patient.
10. Life expectancy > 3 months.
11. All patients of childbearing potential are willing to use adequate contraceptive precautions.
12. Written, informed consent.
13. Access to an approved PET-CT scanning facility
Main Exclusion Criteria
1. Poorly controlled Diabetes mellitus
2. Other concurrent uncontrolled medical condition
3. Pregnant or lactating
4. Central nervous system or meningeal involvement by the lymphoma
5. Cardiac contra-indication to doxorubicin: abnormal contractility on echocardiography or nuclear medicine examination (MUGA).
6. Neurological contra-indication to chemotherapy (e.g. pre-existing neuropathy).
7. General status that does not allow the administration of a full course of chemotherapy according to the investigator.
8. Concurrent active malignancy other than fully excised non melanoma skin cancer or squamous cell carcinoma of the cervix. Subjects with previous malignancies are eligible provided that they have been disease free for at least 5 years.
9. Known positive serology for HIV, Hepatitis B or Hepatitis C (but no requirement for routine testing in the absence of risk factors).
10. Medical or psychiatric conditions that compromise the patient’s ability to give informed consent.
Chief Investigator(s)
Prof Peter Johnson
Further details, please contact
Ms Lindsey Stevens

Cancer Research UK
Lymphoma Trials Office
90 Tottenham Court Road
London
W1T 4TJ
UNITED KINGDOM

Tel: 020 7679 9868
l.stevens@ctc.ucl.ac.uk
Funder(s) Cancer Research UK
Sponsor(s) University College London




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