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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/show/NCT00377195




Registration number
NCT00377195
Ethics application status
Date submitted
14/09/2006
Date registered
18/09/2006
Date last updated
28/02/2018

Titles & IDs
Public title
Involved Field Radiotherapy for Non-gastric Marginal Zone Lymphoma
Scientific title
A Prospective Single Arm Trial of Involved Field Radiotherapy Alone for Stage I-II Low Grade Non-gastric Marginal Zone Lymphoma
Secondary ID [1] 0 0
TROG 05.02
Universal Trial Number (UTN)
Trial acronym
Linked study record

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

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Other - Involved Field Radiotherapy

Experimental: 1 -


Treatment: Other: Involved Field Radiotherapy
The prescribed dose will be 30 Gy in 15-20 fractions, unless the orbit is to be treated, in which case the dose will be 24 Gy in 1.5 to 2 Gy fractions.
Daily fractions of 1.5-2.0 Gy will be employed. Treatment will be given 5 days per week with the planned duration of treatment not exceeding 28 days.

Intervention code [1] 0 0
Treatment: Other
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Freedom from locoregional progression (FFLRP) rate
Timepoint [1] 0 0
There will be an interim analysis at the end of accual (approx 5 years), at 5 years from the end of accrual and a final analysis at 10 years form the end of accrual.
Primary outcome [2] 0 0
Complete response rate
Timepoint [2] 0 0
A final analysis at 10 years form the end of accrual.
Primary outcome [3] 0 0
Cancer-specific survival
Timepoint [3] 0 0
A final analysis at 10 years form the end of accrual.
Secondary outcome [1] 0 0
Overall survival
Timepoint [1] 0 0
A final analysis at 10 years form the end of accrual.
Secondary outcome [2] 0 0
Progression free survival
Timepoint [2] 0 0
A final analysis at 10 years form the end of accrual.
Secondary outcome [3] 0 0
Freedom from progression
Timepoint [3] 0 0
A final analysis at 10 years form the end of accrual.
Secondary outcome [4] 0 0
Acute and Late Toxicity rates
Timepoint [4] 0 0
There will be an interim analysis at the end of accual (approx 5 years), at 5 years from the end of accrual and a final analysis at 10 years form the end of accrual.

Eligibility
Key inclusion criteria
- Patients of at least 18 years old with histologically documented non-gastric marginal
zone lymphoma.

- Disease limited to stages I and II after adequate staging (see Appendix II), 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 30 Gy within the tolerance of the relevant normal
tissues. If paired organ involvement was regarded as a single extranodal site (rather
than 2 separate sites and hence 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.

- Anticipated life expectancy > 2 years

- Given written informed consent

- Been assessed by a radiation oncologist

- Agree to undergo breath testing for H. pylori and/or oesophagogastroduodenoscopy to
exclude active infection with helicobacter pylori

- Must be available for long-term follow up
Minimum age
18 Years
Maximum age
No limit
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
- Splenic marginal zone lymphoma

- Received previous locoregional radiotherapy

- A medical contraindication to radiotherapy

- 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 radiotherapy alone would
be hazardous because of excessive lung irradiation, even if a shrinking field
technique were employed

- Suspected or confirmed pregnancy

- Transformation to large cell lymphoma or other aggressive histology

- 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)
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)
Statistical methods / analysis

Recruitment
Recruitment status
Unknown status
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW,QLD,SA,VIC
Recruitment hospital [1] 0 0
Royal Prince Alfred Hospital - Camperdown
Recruitment hospital [2] 0 0
Calvary Mater Newcastle - Newcastle
Recruitment hospital [3] 0 0
Royal Brisbane and Women's Hospital - Brisbane
Recruitment hospital [4] 0 0
Royal Adelaide Hospital - Adelaide
Recruitment hospital [5] 0 0
Peter MacCallum Cancer Centre - Melbourne
Recruitment postcode(s) [1] 0 0
- Camperdown
Recruitment postcode(s) [2] 0 0
- Newcastle
Recruitment postcode(s) [3] 0 0
- Brisbane
Recruitment postcode(s) [4] 0 0
- Adelaide
Recruitment postcode(s) [5] 0 0
3000 - Melbourne

Funding & Sponsors
Primary sponsor type
Other
Name
Trans-Tasman Radiation Oncology Group (TROG)
Address
Country
Other collaborator category [1] 0 0
Other
Name [1] 0 0
Australasian Leukaemia and Lymphoma Group
Address [1] 0 0
Country [1] 0 0
Other collaborator category [2] 0 0
Other
Name [2] 0 0
Peter MacCallum Cancer Centre, Australia
Address [2] 0 0
Country [2] 0 0

Ethics approval
Ethics application status

Summary
Brief summary
This prospective study will test the following hypotheses in patients with stage I-II low
grade marginal zone (MZ) lymphoma:

- Involved Field Radiotherapy will produce a complete response rate of > 90%

- Radiotherapy will be associated with a locoregional progression of < 20% after 10 years

- Death from MZ lymphoma will occur in < 40% of patients within 10 years of radiotherapy

This study secondary objectives are:

- To collect information on the prevalence of H. pylori in non-gastric MALT lymphoma

- To estimate rates of acute and late toxicity of radiotherapy
Trial website
https://clinicaltrials.gov/show/NCT00377195
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Michael MacManus
Address 0 0
Peter MacCallum Cancer Centre, Australia
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

Summary results
For IPD and results data, please see https://clinicaltrials.gov/show/NCT00377195