Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12607000164493
Ethics application status
Approved
Date submitted
5/03/2007
Date registered
12/03/2007
Date last updated
1/02/2017
Type of registration
Prospectively registered

Titles & IDs
Public title
Involved Field Radiotherapy for Non-Gastric Marginal Zone Lymphoma
Scientific title
Trans Tasman Radiation Oncology Group (TROG) 05.02 - A Prospective Single Arm Trial of Involved Field Radiotherapy Alone for Stage I-II Low Grade Non-Gastric Marginal Zone Lymphoma to improve response rates.
Secondary ID [1] 347 0
Clinicaltrials.gov: NCT00377195
Universal Trial Number (UTN)
Trial acronym
TROG 05.02
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Non-Gastric Marginal Zone Lymphoma 1670 0
Condition category
Condition code
Cancer 1774 1774 0 0
Lymphoma (non Hodgkin's lymphoma) - Low grade lymphoma

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
All patients receive a Helicobacter Pylori (H.Pylori) Breath test. If this is positive, they undergo H.Pylori eradication. Then all pateints receive Radiotherapy 24-30Gy. Daily fractions of 1.5 -2.0 Gy, 5 days per week with a duration of 4 weeks.
Intervention code [1] 1629 0
Treatment: Other
Comparator / control treatment
No comparator.
Control group
Uncontrolled

Outcomes
Primary outcome [1] 2479 0
Freedom from locoregional progression (FFLRP) rate - will be estimated as the cumulative incidence of locoregional progression as obtained as part of a competing risks analysis in which the competing events are distant progression and death without prior progression.
Timepoint [1] 2479 0
Six to eight weeks after completion of radiotherapy, all patients require interim follow up. After the first follow-up, regular follow-up visits will then occur as follows: 3-monthly intervals for 2 years following restaging; then 6-monthly until 5 years. The analysis of this outcome will be done at 5 years.
Primary outcome [2] 2480 0
Complete response rate - Disappearance of all clinical and radiological evidence of tumour.
Timepoint [2] 2480 0
Six to eight weeks after completion of radiotherapy, all patients require interim follow up. After the first follow-up, regular follow-up visits will then occur as follows: 3-monthly intervals for 2 years following restaging; then 6-monthly until 5 years. The analysis of this outcome will be done at 5 years.
Secondary outcome [1] 4256 0
Overall survival
Timepoint [1] 4256 0
Overall survival (OS) will be measured as the time from treatment start to date of death from any cause.
Secondary outcome [2] 4257 0
Progression free survival
Timepoint [2] 4257 0
Period from the date of treatment start to 1st progression of disease or death from any cause.
Secondary outcome [3] 4258 0
Freedom from progression - Freedom from progression (FFP) will be estimated as the cumulative incidence of progression obtained as part of a competing risks analysis in which the competing event is death without prior progression.
Timepoint [3] 4258 0
Six to eight weeks after completion of radiotherapy, all patients require interim follow up. After the first follow-up, regular follow-up visits will then occur as follows: 3-monthly intervals for 2 years following restaging; then 6-monthly until 5 years; then annually thereafter until death.
Secondary outcome [4] 4259 0
Acute and Late Toxicity rates - Toxicities of radiotherapy will be recorded employing CTCAE version 3 (Common Terminology Criteria for Adverse Events v3.0 (CTCAE).
Timepoint [4] 4259 0
Six to eight weeks after completion of radiotherapy, all patients require late toxicity check.

Eligibility
Key inclusion criteria
1. Patients of at least 18 years of age with histologically documented non-gastric marginal zone lymphoma. 2. Disease limited to stages I and II after adequate staging, patients with stage IV with extranodal disease confined to paired organs (e.g. salivary glands) and including any local extension of this disease into adjacent tissues. Patients with involved lymph nodes on the same side of the diaphragm in addition to paired organ involvement are also eligible, provided all involved tumour sites, nodal and extranodal, can be irradiated to 30Gy within tolerance of the relevent normal tissues. If paired organ involvement was regarded as a single extranodal site (rather than 2 seperate sites and hencs stage IV), eligible patients would then be regarded as having stage IE or IIE disease. Patients with wider dissemination (bone Marrow, liver etc) are ineligible. 3. Anticipated life expectancy > 2 years 4. Given written informed consent 5. Been assessed by a radiation oncologist 6. Agree to undergo breath testing for H. pylori and/or oesophagogastroduodenoscopy to exclude active infection with helicobacter pylori 7. Must be available for long-term follow up.
Minimum age
18 Years
Maximum age
Not stated
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1. Splenic marginal zone lymphoma 2. Received previous locoregional radiotherapy 3. A medical contraindication to radiotherapy 4. 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. 5. Such extensive involvement of the thorax that treatment with radiotherapy alone would be hazardous because of excessive lung irradiation, even if a shrinking field technique were employed 6. Suspected or confirmed pregnancy. 7. Transformation to large cell lymphoma or other aggressive histology. 8. Disease that is widely disseminated (bone marrow, liver etc)

Study design
Purpose of the study
Treatment
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
This is a non randomised trial, so all participants receive the same treatment after registration
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Phase 2
Type of endpoint/s
Safety/efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Active, not recruiting
Date of first participant enrolment
Anticipated
25/02/2005
Actual
8/06/2007
Date of last participant enrolment
Anticipated
Actual
30/10/2014
Date of last data collection
Anticipated
31/12/2017
Actual
Sample size
Target
100
Accrual to date
Final
70
Recruitment in Australia
Recruitment state(s)
NSW,QLD,SA,VIC
Recruitment hospital [1] 1391 0
Austin Health - Austin Hospital - Heidelberg
Recruitment hospital [2] 1392 0
Calvary Mater Newcastle - Waratah
Recruitment hospital [3] 1393 0
Peter MacCallum Cancer Institute - East Melbourne
Recruitment hospital [4] 1394 0
The Royal Adelaide Hospital - Adelaide
Recruitment hospital [5] 1395 0
Royal Brisbane & Womens Hospital - Herston
Recruitment hospital [6] 1396 0
Royal Prince Alfred Hospital - Camperdown

Funding & Sponsors
Funding source category [1] 1924 0
Government body
Name [1] 1924 0
Australian National Health and Medical Research Council
Country [1] 1924 0
Australia
Primary sponsor type
Other Collaborative groups
Name
Trans Tasman Radiation Oncology Group (TROG)
Address
Peter MacCallum Cancer Centre St Andrews Place East Melbourne
Country
Australia
Secondary sponsor category [1] 290034 0
None
Name [1] 290034 0
Address [1] 290034 0
Country [1] 290034 0
Other collaborator category [1] 277566 0
Other Collaborative groups
Name [1] 277566 0
Australiasian Leukemia and Lymphome Group
Address [1] 277566 0
Room 502, Level 5
10 St Andrews Place
East Melbourne, VIC 3002
Country [1] 277566 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 3578 0
Peter MacCallum Cancer Centre
Ethics committee address [1] 3578 0
Melbourne, VIC
Ethics committee country [1] 3578 0
Australia
Date submitted for ethics approval [1] 3578 0
Approval date [1] 3578 0
30/08/2006
Ethics approval number [1] 3578 0
Ethics committee name [2] 3579 0
Calvary Mater Newcastle
Ethics committee address [2] 3579 0
Ethics committee country [2] 3579 0
Australia
Date submitted for ethics approval [2] 3579 0
Approval date [2] 3579 0
Ethics approval number [2] 3579 0
Ethics committee name [3] 3580 0
Royal Adelaide Hospital
Ethics committee address [3] 3580 0
Adelaide, SA
Ethics committee country [3] 3580 0
Australia
Date submitted for ethics approval [3] 3580 0
Approval date [3] 3580 0
Ethics approval number [3] 3580 0

Summary
Brief summary
This prospective study will test the following hypotheses in patients with stage I-II low grade marginal zone (MZ) lymphoma:
1. Involved Field Radiotherapy will produce a complete response rate of > 90%
2. Radiotherapy will be associated with a locoregional progression of < 20% after 10 years
3. Death from MZ lymphoma will occur in < 40% of patients within 10 years of radiotherapy

This study secondary objectives are:
1. To collect information on the prevalence of H. pylori in non-gastric MALT lymphoma
2. To estimate rates of acute and late toxicity of radiotherapy
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 27563 0
A/Prof Michael macManus
Address 27563 0
Division of Radiation Oncology
Peter MacCallum Cancer Centre
305 Grattan Street
Melbourne VIC 3000
Australia
Country 27563 0
Australia
Phone 27563 0
+61 3 9656 1111
Fax 27563 0
Email 27563 0
Michael.MacManus@petermac.org
Contact person for public queries
Name 10818 0
Ms Janani Sivasuthan
Address 10818 0
Peter MacCallum Cancer Centre
305 Grattan Street
Melbourne VIC 3000
Australia
Country 10818 0
Australia
Phone 10818 0
+61 3 9656 5802
Fax 10818 0
+61 3 9656 1420
Email 10818 0
janani.sivasuthan@petermac.org
Contact person for scientific queries
Name 1746 0
A/Prof Michael MacManus
Address 1746 0
Peter MacCallum Cancer Centre
305 Grattan Street
Melbourne VIC 3000
Australia
Country 1746 0
Australia
Phone 1746 0
+61 3 9656 1111
Fax 1746 0
+61 3 9656 1424
Email 1746 0
Michael.MacManus@petermac.org

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
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