Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12607000112460
Ethics application status
Approved
Date submitted
14/07/2000
Date registered
14/07/2000
Date last updated
10/12/2019
Date data sharing statement initially provided
10/12/2019
Type of registration
Retrospectively registered

Titles & IDs
Public title
Radiotherapy versus radiotherapy plus chemotherapy in early stage follicular lymphoma
Scientific title
Trans Tasman Radiation Oncology Group (TROG) 99.03 - A randomised multicentre trial of involved field radiotherapy versus involved field radiotherapy plus chemotherapy (cyclophosphamide, vincristine Prednisolone) in combination with Rituximb (Mabthera) for stage I-II low grade follicular lymphoma to improve progression free survival
Secondary ID [1] 65 0
National Clinical Trials Registry: NCTR325
Secondary ID [2] 66 0
ClinicalTrials.gov: NCT00115700
Secondary ID [3] 67 0
The Australasian Leukaemia and Lymphoma Group: ALLG NHLLOW5
Universal Trial Number (UTN)
Trial acronym
TROG 99.03
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Stage I-II low grade follicular lymphoma 19 0
Condition category
Condition code
Cancer 19 19 0 0
Lymphoma (non Hodgkin's lymphoma) - Low grade lymphoma

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Arm 1: Involved field radiotherapy 30-36Gy. Daily fractions of 1.5-2.0 Gy. Will be given 5 days per week. Cyclophosphamide 1000mg per metre squared IV on day 1. Vincristine 1.4mg per metre squared IV on day 1, Prednisolone 50mg per metre squared orally for days 1-5, Rituximab 375mg per metre squared IV infusion day 1. A total of six 21 day cycles of CVP plus rituximab should be administered.
Intervention code [1] 1468 0
Treatment: Drugs
Comparator / control treatment
Arm 2: Involved field radiotherapy 30-36Gy. Daily fractions of 1.5-2.0 Gy. Will be given 5 days per week for 3 weeks. Involved field radiotherapy: radiotherapy of the known disease region with a suitable margin (+/- nearby univolved lymph node groups are irradiated)
Control group
Active

Outcomes
Primary outcome [1] 101 0
Progression free survival. Period from date of randomisation to first progression of disease or death from any cause.
Timepoint [1] 101 0
Follow-up visits will occur as follows: 3-monthly intervals for 2 years, commencing 3 months after the completion of protocol treatment, then 6-monthly until 5 years, then annually thereafter until 10 years after the end of accrual.
Secondary outcome [1] 203 0
1. Pre- and post-treatment prevalence of the t(14;18) translocation in peripheral blood and bone marrow between arms.
Timepoint [1] 203 0
Measured by Polymerase Chain Reaction (PCR) before treatment commences, at 1 year and upon first relapse. t(14;18): means translocation of a section of chromosome 18 to a section of chromosome 14. This results in dysregulated expression in bcl-2 gene.
Secondary outcome [2] 204 0
2. Overall survival.
Timepoint [2] 204 0
Follow-up visits will occur as follows: 3-monthly intervals for 2 years, commencing 3 months after the completion of protocol treatment, then 6-monthly until 5 years, then annually thereafter until 10 years after the end of accrual.
Secondary outcome [3] 205 0
3. Location of first relapse. If it is nodal, extranodal or systemic.
Timepoint [3] 205 0
Follow-up visits will occur as follows: 3-monthly intervals for 2 years, commencing 3 months after the completion of protocol treatment, then 6-monthly until 5 years, then annually thereafter until 10 years after the end of accrual.
Secondary outcome [4] 206 0
4. Time to histologic progression.
Timepoint [4] 206 0
Follow-up visits will occur as follows: 3-monthly intervals for 2 years, commencing 3 months after the completion of protocol treatment, then 6-monthly until 5 years, then annually thereafter until 10 years after the end of accrual.

Eligibility
Key inclusion criteria
- Adult patients (= 18 years old) with histologically documented “follicular lymphoma, grade 1", "follicular lymphoma, grade 2", or "follicular lymphoma, grade 3a" diagnosed following an excisional, incisional or generous core biopsy (i.e. an FNA alone is insufficient).
- Disease limited to stages I and II after adequate staging
- Anticipated life expectancy > 5 years
- Given written informed consent
- Been assessed by a radiation oncologist and a medical oncologist/ haematologist
- White Cell Count (WCC) > 3.0 x 10^9/L, platelet count > 100 x 10^9/L, serum creatinine < 0.15 mmol/L
- Ability to commence radiotherapy within 6 weeks of randomisation
- Women using effective contraception, are not pregnant and agree not to become pregnant during participating in the trial and during the 12 months thereafter. Men agree not to father a child during participation in the trial and during the 12 months thereafter.
Minimum age
18 Years
Maximum age
Not stated
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Received previous systemic cytotoxic chemotherapy.
- Received previous radiotherapy, (except superficial radiation therapy for non-melanoma skin cancers).
- Received previous immunotherapy
- A medical contraindication to radiotherapy or rituximab.
- Any previous or concurrent malignancy other than curatively treated non-melanoma skin cancer, level 1 malignant melanoma, or in situ cervical cancer, unless disease and treatment-free for 5 years.
- Such extensive involvement of the thorax that treatment with radiation therapy alone would be hazardous because of excessive lung irradiation, even if a shrinking field technique were employed.
- Patients who have known human immuno-deficiency virus (HIV) infection or active hepatitis B (HBV)
- Treatment within a clinical study within 30 days prior to study entry
- Suspected or confirmed pregnancy. Must not be lactating.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Central randomisation by computer
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Stratification: Centre, Stage (I/II), Age (<60/>=60), Whether PET staged. Simple randomisation by computer
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Phase 3
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Active, not recruiting
Date of first participant enrolment
Anticipated
1/02/2000
Actual
14/02/2000
Date of last participant enrolment
Anticipated
Actual
12/07/2012
Date of last data collection
Anticipated
31/12/2022
Actual
Sample size
Target
150
Accrual to date
Final
150
Recruitment in Australia
Recruitment state(s)
ACT,NSW,QLD,SA,TAS,WA
Recruitment outside Australia
Country [1] 435 0
New Zealand
State/province [1] 435 0
Country [2] 436 0
Canada
State/province [2] 436 0

Funding & Sponsors
Funding source category [1] 25 0
Government body
Name [1] 25 0
Cancer Council Victoria
Country [1] 25 0
Australia
Funding source category [2] 26 0
Commercial sector/Industry
Name [2] 26 0
AMGEN
Country [2] 26 0
Australia
Primary sponsor type
Individual
Name
Michael MacManus
Address
Peter MacCallum Cancer Centre Department of Radiation Oncology Locked Bag 1 A'Beckett Street VIC 8006
Country
Australia
Secondary sponsor category [1] 23 0
Other Collaborative groups
Name [1] 23 0
Trans Tasman Radiation Oncology Group (TROG)
Address [1] 23 0
Edith St Waratah NSW 2298
Country [1] 23 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 687 0
Austin Hospital
Ethics committee address [1] 687 0
Ethics committee country [1] 687 0
Australia
Date submitted for ethics approval [1] 687 0
Approval date [1] 687 0
11/08/1999
Ethics approval number [1] 687 0
Ethics committee name [2] 688 0
Auckland Hospital
Ethics committee address [2] 688 0
Ethics committee country [2] 688 0
New Zealand
Date submitted for ethics approval [2] 688 0
Approval date [2] 688 0
Ethics approval number [2] 688 0
Ethics committee name [3] 689 0
Canberra Hospital
Ethics committee address [3] 689 0
Ethics committee country [3] 689 0
Australia
Date submitted for ethics approval [3] 689 0
Approval date [3] 689 0
Ethics approval number [3] 689 0
Ethics committee name [4] 690 0
Premion Tugun
Ethics committee address [4] 690 0
Ethics committee country [4] 690 0
Australia
Date submitted for ethics approval [4] 690 0
Approval date [4] 690 0
Ethics approval number [4] 690 0
Ethics committee name [5] 691 0
Barwon Health - Andrew Love Cancer Care Centre, Geelong Hospital
Ethics committee address [5] 691 0
Ethics committee country [5] 691 0
Australia
Date submitted for ethics approval [5] 691 0
Approval date [5] 691 0
Ethics approval number [5] 691 0
Ethics committee name [6] 692 0
Launceston Hospital
Ethics committee address [6] 692 0
Ethics committee country [6] 692 0
Australia
Date submitted for ethics approval [6] 692 0
Approval date [6] 692 0
Ethics approval number [6] 692 0
Ethics committee name [7] 693 0
Mater QRI
Ethics committee address [7] 693 0
Ethics committee country [7] 693 0
Australia
Date submitted for ethics approval [7] 693 0
Approval date [7] 693 0
Ethics approval number [7] 693 0
Ethics committee name [8] 694 0
Murray Valley Private Hospital
Ethics committee address [8] 694 0
Ethics committee country [8] 694 0
Australia
Date submitted for ethics approval [8] 694 0
Approval date [8] 694 0
Ethics approval number [8] 694 0
Ethics committee name [9] 695 0
Calvary Mater Newcastle
Ethics committee address [9] 695 0
Ethics committee country [9] 695 0
Australia
Date submitted for ethics approval [9] 695 0
Approval date [9] 695 0
Ethics approval number [9] 695 0
Ethics committee name [10] 696 0
Peter MacCallum Cancer Centre
Ethics committee address [10] 696 0
Ethics committee country [10] 696 0
Australia
Date submitted for ethics approval [10] 696 0
Approval date [10] 696 0
Ethics approval number [10] 696 0
Ethics committee name [11] 697 0
Prince of Wales (Hong Kong)
Ethics committee address [11] 697 0
Ethics committee country [11] 697 0
Hong Kong
Date submitted for ethics approval [11] 697 0
Approval date [11] 697 0
Ethics approval number [11] 697 0
Ethics committee name [12] 698 0
Prince of Wales Hospital
Ethics committee address [12] 698 0
Ethics committee country [12] 698 0
Australia
Date submitted for ethics approval [12] 698 0
Approval date [12] 698 0
Ethics approval number [12] 698 0
Ethics committee name [13] 699 0
Princess Alexandra Hospital
Ethics committee address [13] 699 0
Ethics committee country [13] 699 0
Australia
Date submitted for ethics approval [13] 699 0
Approval date [13] 699 0
Ethics approval number [13] 699 0
Ethics committee name [14] 700 0
Princess Margaret (Toronto)
Ethics committee address [14] 700 0
Ethics committee country [14] 700 0
Canada
Date submitted for ethics approval [14] 700 0
Approval date [14] 700 0
Ethics approval number [14] 700 0
Ethics committee name [15] 701 0
Queen Elizabeth
Ethics committee address [15] 701 0
Ethics committee country [15] 701 0
Australia
Date submitted for ethics approval [15] 701 0
Approval date [15] 701 0
Ethics approval number [15] 701 0
Ethics committee name [16] 702 0
Royal Adelaide Hospital
Ethics committee address [16] 702 0
Ethics committee country [16] 702 0
Australia
Date submitted for ethics approval [16] 702 0
Approval date [16] 702 0
Ethics approval number [16] 702 0
Ethics committee name [17] 703 0
Royal Brisbane and Women's Hospital
Ethics committee address [17] 703 0
Ethics committee country [17] 703 0
Australia
Date submitted for ethics approval [17] 703 0
Approval date [17] 703 0
Ethics approval number [17] 703 0
Ethics committee name [18] 704 0
Sir Charles Gairdner Hospital
Ethics committee address [18] 704 0
Ethics committee country [18] 704 0
Australia
Date submitted for ethics approval [18] 704 0
Approval date [18] 704 0
Ethics approval number [18] 704 0
Ethics committee name [19] 705 0
St George Hospital
Ethics committee address [19] 705 0
Ethics committee country [19] 705 0
Australia
Date submitted for ethics approval [19] 705 0
Approval date [19] 705 0
Ethics approval number [19] 705 0
Ethics committee name [20] 706 0
Waikato Hospital
Ethics committee address [20] 706 0
Ethics committee country [20] 706 0
New Zealand
Date submitted for ethics approval [20] 706 0
Approval date [20] 706 0
Ethics approval number [20] 706 0
Ethics committee name [21] 707 0
Wellington Hospital
Ethics committee address [21] 707 0
Ethics committee country [21] 707 0
New Zealand
Date submitted for ethics approval [21] 707 0
Approval date [21] 707 0
Ethics approval number [21] 707 0
Ethics committee name [22] 708 0
Westmead Hospital
Ethics committee address [22] 708 0
Ethics committee country [22] 708 0
Australia
Date submitted for ethics approval [22] 708 0
Approval date [22] 708 0
Ethics approval number [22] 708 0
Ethics committee name [23] 7009 0
Christchurch Hospital
Ethics committee address [23] 7009 0
Ethics committee country [23] 7009 0
New Zealand
Date submitted for ethics approval [23] 7009 0
Approval date [23] 7009 0
Ethics approval number [23] 7009 0

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 27402 0
A/Prof Michael MacManus
Address 27402 0
Peter MacCallum Cancer Centre Department of Radiation Oncology Locked Bag 1 A'Beckett Street VIC 8006
Country 27402 0
Australia
Phone 27402 0
+61 3 9656 1111
Fax 27402 0
Email 27402 0
Michael.MacManus@petermac.org
Contact person for public queries
Name 10657 0
Bev McClure
Address 10657 0
Peter MacCallum Cancer Centre
Department of Radiation Oncology
Locked Bag 1
A'Beckett Street VIC 8006
Country 10657 0
Australia
Phone 10657 0
+61 3 9656 1266
Fax 10657 0
Email 10657 0
Bev.McClure@petermac.org
Contact person for scientific queries
Name 1585 0
Michael MacManus
Address 1585 0
Peter MacCallum Cancer Centre
Department of Radiation Oncology
Locked Bag 1 A'Beckett Street VIC 8006
Country 1585 0
Australia
Phone 1585 0
+61 3 9656 1111
Fax 1585 0
Email 1585 0
Michael.MacManus@petermac.org

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No/undecided IPD sharing reason/comment


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.