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Trial registered on ANZCTR
Registration number
ACTRN12610000927022
Ethics application status
Approved
Date submitted
25/10/2010
Date registered
1/11/2010
Date last updated
1/06/2024
Date data sharing statement initially provided
18/06/2020
Date results information initially provided
18/06/2020
Type of registration
Retrospectively registered
Titles & IDs
Public title
A randomised Phase III Trial to assess response adapted therapy using 2-[F-18]fluoro-2-deoxy-d-glucose positron emission tomography (FDG-PET) imaging in patients with newly diagnosed, advanced Hodgkin Lymphoma
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Scientific title
A randomised Phase III Trial to assess response adapted therapy using 2-[F-18]fluoro-2-deoxy-d-glucose positron emission tomography (FDG-PET) imaging in patients with newly diagnosed, advanced Hodgkin Lymphoma
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Secondary ID [1]
252938
0
clinicaltrials. gov. NCT00678327
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Universal Trial Number (UTN)
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Trial acronym
RATHL HD8
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Hodgkin Lymphoma
258469
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Condition category
Condition code
Cancer
258635
258635
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0
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Hodgkin's
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Subjects follow different treatment courses depending on outcomes of Positron Emission Tomography (PET) scans at various stage during the trial.
The drugs used in treatment are as follows:
bleomycin sulfate
filgrastim
pegfilgrastim
cyclophosphamide
dacarbazine
doxorubicin hydrochloride
etoposide
prednisolone
procarbazine hydrochloride
vinblastine
vincristine sulfate
Subjects undergo 2 cycles of ABVD and then have a PET scan. PET negative patients are subsequently randomised between ABVD for 4 cycles of AVD (25mg/m2 doxorubicin intravenously (i.v) days 1,15; 6mg/m2 vinblastine i.v days 1,15; Dacarbazine 375mg/m2 i.v days 1,15) for 4 cycles, before progressing to response assessment. PET positive patients undergo either 4-6 14 day cycles of BEACOPP-14 (25mg/m2 doxorubicin iv day 1; cyclophosphamide 650mg/m2 iv day 1; Etoposide 100mg/m2 i.v days 1-3; Procarbazine 100mg/m2 per oral (po) days 1-7; Prednisolone 80mg/m2 po days 1-7; Bleomycin 10,000units/m2 i.v day 8; vincristine 1.4-2mg i.v day 8; G-CSF 263/300mcg subcutaneously (s.c) days 9-13 or Peg filgastrim single dose) or 3-4 cycles of 21 day BEACOPP escalated (35mg/m2 doxorubicin i.v day 1; cyclophosphamide 1250mg/m2 i.v day 1; Etoposide 200mg/m2 i.v days 1-3; Procarbazine 100mg/m2 po days 1-7; Prednisolone 40mg/m2 po days 1-14; Bleomycin 10,000units/m2 i.v day 8; vincristine 1.4-2mg i.v day 8; G-CSF 263/300mcg s.c days 9-13 or Peg filgastrim single dose)(choice of therapy determined in advance by centre) before progressing to another PET scan. PET negative patients on this scan undergo either 2 cycles of BEACOPP-14 or 1 more cycle of BEACOPP-escalated. PET positive patients have either radiation or salvage therapy at Investigator discretion before progressing to response assessment.
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Intervention code [1]
257464
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Treatment: Drugs
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Comparator / control treatment
nil
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Control group
Uncontrolled
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Outcomes
Primary outcome [1]
259479
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Progression-free survival
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Assessment method [1]
259479
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Timepoint [1]
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3 years
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Secondary outcome [1]
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overall survival
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Assessment method [1]
266060
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Timepoint [1]
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5 years following initial PET scan following 2 cycles of ABVD (Doxorubicin 25mg/m2 iv days 1,15; Bleomycin 10,000units/m2 iv days 1,15; Vinblastine 6mg/m2 iv days 1,15; Dacarbazine 375mg/m2 iv days 1,15)
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Secondary outcome [2]
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toxicity (acute and chronic) using National Cancer Institute criteria
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Assessment method [2]
266061
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Timepoint [2]
266061
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5 years following initial PET scan following 2 cycles of ABVD
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Eligibility
Key inclusion criteria
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
6. Adequate bone marrow function with platelets > 100x10e9/l; neutrophils > 1.5x10e9/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 < 2.5× 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. Life expectancy > 3 months
10. All patients of childbearing potential are willing to use adequate contraceptive precautions
11. Written, informed consent
12. Access to PET-CT scanning
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Minimum age
18
Years
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Maximum age
No limit
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Sex
Both males and females
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Can healthy volunteers participate?
No
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Key exclusion criteria
1. Poorly controlled Diabetes mellitus
2. Other concurrent uncontrolled medical condition
3. Pregnant or lactating
4. Known 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. Previous history of active malignant disease other than fully excised basal or squamous cell carcinoma of the skin or carcinoma in situ of the uterine cervix in the last 10 years
9. Known positive serology for human immunodeficiency virus (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
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Non-randomised trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Central enrolment through the United Kingdom and allocation of trial Identification number. Follwoing enrolment all data will be collected under trial identification number.
Study is not blinded therefore no concealment of allocated treatment required.
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
sequential number allocation in order patients are registered.
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Masking / blinding
Open (masking not used)
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Who is / are masked / blinded?
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Intervention assignment
Other
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Other design features
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Phase
Phase 3
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Type of endpoint/s
Efficacy
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Statistical methods / analysis
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Recruitment
Recruitment status
Completed
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Date of first participant enrolment
Anticipated
9/09/2010
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Actual
9/09/2010
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Date of last participant enrolment
Anticipated
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Actual
4/12/2012
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Date of last data collection
Anticipated
21/07/2021
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Actual
30/04/2024
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Sample size
Target
1200
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Accrual to date
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Final
1203
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Recruitment in Australia
Recruitment state(s)
NSW,VIC,ACT,QLD,SA,WA,NT,TAS
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Recruitment hospital [1]
8150
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Peter MacCallum Cancer Centre - Melbourne
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Recruitment hospital [2]
8151
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Concord Repatriation Hospital - Concord
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Recruitment hospital [3]
8152
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Border Medical Oncology - Albury
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Recruitment hospital [4]
8153
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Royal Prince Alfred Hospital - Camperdown
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Recruitment hospital [5]
8154
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Westmead Hospital - Westmead
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Recruitment hospital [6]
8155
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Royal North Shore Hospital - St Leonards
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Recruitment hospital [7]
8156
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Prince of Wales Hospital - Randwick
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Recruitment hospital [8]
8157
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Princess Alexandra Hospital - Woolloongabba
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Recruitment hospital [9]
8158
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Sir Charles Gairdner Hospital - Nedlands
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Recruitment hospital [10]
8159
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The Canberra Hospital - Garran
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Recruitment hospital [11]
8160
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Royal Darwin Hospital - Tiwi
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Recruitment hospital [12]
8161
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Royal Hobart Hospital - Hobart
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Recruitment hospital [13]
8162
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Western Hospital - Footscray - Footscray
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Recruitment hospital [14]
8163
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Cairns Base Hospital - Cairns
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Recruitment postcode(s) [1]
16211
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3000 - Melbourne
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Recruitment postcode(s) [2]
16212
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2139 - Concord
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Recruitment postcode(s) [3]
16213
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3690 - Wodonga
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Recruitment postcode(s) [4]
16214
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2050 - Camperdown
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Recruitment postcode(s) [5]
16215
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2145 - Westmead
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Recruitment postcode(s) [6]
16216
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2065 - St Leonards
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Recruitment postcode(s) [7]
16217
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2031 - Randwick
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Recruitment postcode(s) [8]
16218
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4102 - Woolloongabba
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Recruitment postcode(s) [9]
16219
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6009 - Nedlands
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Recruitment postcode(s) [10]
16220
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2605 - Garran
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Recruitment postcode(s) [11]
16221
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0810 - Tiwi
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Recruitment postcode(s) [12]
16222
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7000 - Hobart
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Recruitment postcode(s) [13]
16223
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3011 - Footscray
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Recruitment postcode(s) [14]
16224
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4870 - Cairns
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Recruitment outside Australia
Country [1]
2986
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United Kingdom
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State/province [1]
2986
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London
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Funding & Sponsors
Funding source category [1]
257920
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Government body
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Name [1]
257920
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National Health and Medical Research Council
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Address [1]
257920
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Level 1
16 Marcus Clarke Street
Canberra ACT 2601
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Country [1]
257920
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Australia
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Primary sponsor type
University
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Name
University College
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Address
Gower St
London WC1E 6BT
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Country
United Kingdom
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Secondary sponsor category [1]
257109
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Other Collaborative groups
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Name [1]
257109
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Australasian Leukaemia and Lymphoma Group
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Address [1]
257109
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Level 2/10 St Andrews Place
East Melbourne, VIC,3002
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Country [1]
257109
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Australia
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Ethics approval
Ethics application status
Approved
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Ethics committee name [1]
259933
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Peter MacCallum Cancer Centre
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Ethics committee address [1]
259933
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St Andrews place
East Melbourne, VIC, 3002
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Ethics committee country [1]
259933
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Australia
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Date submitted for ethics approval [1]
259933
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Approval date [1]
259933
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14/07/2011
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Ethics approval number [1]
259933
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Ethics committee name [2]
297794
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Sydney South West Area HREC
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Ethics committee address [2]
297794
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Concord Repatriation General Hospital
Concord 2139
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Ethics committee country [2]
297794
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Australia
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Date submitted for ethics approval [2]
297794
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16/12/2009
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Approval date [2]
297794
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16/12/2009
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Ethics approval number [2]
297794
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Ethics committee name [3]
297795
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Metro South Hospital and Health Service HREC
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Ethics committee address [3]
297795
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Princess Alexandra Hospital
Woollongabba
QLD 4102
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Ethics committee country [3]
297795
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Australia
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Date submitted for ethics approval [3]
297795
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20/05/2010
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Approval date [3]
297795
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08/12/2009
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Ethics approval number [3]
297795
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09/QPAH/302
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Ethics committee name [4]
297796
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Northern Territories Department of Health HREC
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Ethics committee address [4]
297796
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Royal Darwin Hospital Campus
Casaurina
NT 0810
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Ethics committee country [4]
297796
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Australia
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Date submitted for ethics approval [4]
297796
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Approval date [4]
297796
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15/07/2011
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Ethics approval number [4]
297796
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2011/1609
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Ethics committee name [5]
297797
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Sir Charles Gairdner Hospital HREC
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Ethics committee address [5]
297797
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Hospital Ave
Nedlands
WA 6009
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Ethics committee country [5]
297797
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Australia
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Date submitted for ethics approval [5]
297797
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Approval date [5]
297797
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10/02/2011
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Ethics approval number [5]
297797
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2010/153
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Ethics committee name [6]
297798
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University of Tasmania HREC
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Ethics committee address [6]
297798
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Office of Research Services
Private Bag 1
Hoabrt
Tasmania 7001
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Ethics committee country [6]
297798
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Australia
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Date submitted for ethics approval [6]
297798
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Approval date [6]
297798
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03/11/2011
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Ethics approval number [6]
297798
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Summary
Brief summary
This study looks at the effectiveness of using fluoro-deoxy-glucose positron emission tomography (FDG-PET) imaging to guide therapy in people with newly diagnosed, advanced Hodgkin lymphoma.
Who is it for?
You may be able to join this study if you have previously untreated advanced Hodgkin lymphoma and are over 18 years of age.
Trial details
Participants receive 2 cycles of the standard chemotherapy regimen (ABVD) and then have a FDG-PET scan, which provides a 3 dimensional image of the lymphoma. Depending on the results of this and future scans, participants are assigned different courses of chemotherapy at various stages during the trial.
The trial aims to see how the different treatments, which are guided by the results of FDG-PET imaging, affect survival rates, and also monitors any toxic effects of treatment.
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Trial website
http://www.cancer.gov/clinicaltrials/CRUK-2007-006064-30
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
31820
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A/Prof Judith Trotman
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Address
31820
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Concord Repatriation General Hospital Hospital Road Concord, NSW, 2139
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Country
31820
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Australia
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Phone
31820
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+61 2 9767 7243
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Fax
31820
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Email
31820
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[email protected]
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Contact person for public queries
Name
15067
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Ms Delaine Smith
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Address
15067
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ALLG
35 Elizabeth Street
Richmond
VIC 3121
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Country
15067
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Australia
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Phone
15067
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+61 3 8373 9701
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Fax
15067
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Email
15067
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[email protected]
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Contact person for scientific queries
Name
5995
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A/Prof Judith Trotman
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Address
5995
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Concord Repatriation General Hospital
Hospital Road
Concord, NSW, 2139
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Country
5995
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Australia
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Phone
5995
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+61 2 9767 7243
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Fax
5995
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Email
5995
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[email protected]
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Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
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No/undecided IPD sharing reason/comment
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What supporting documents are/will be available?
No Supporting Document Provided
Results publications and other study-related documents
Documents added manually
No documents have been uploaded by study researchers.
Documents added automatically
No additional documents have been identified.
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