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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/show/NCT00115700




Registration number
NCT00115700
Ethics application status
Date submitted
23/06/2005
Date registered
24/06/2005
Date last updated
12/07/2017

Titles & IDs
Public title
Radiotherapy Versus Radiotherapy Plus Chemotherapy in Early Stage Follicular Lymphoma
Scientific title
A Randomised Multicentre Trial of Involved Field Radiotherapy Versus Involved Field Radiotherapy Plus Chemotherapy in Combination With Rituximab (Mabthera®) for Stage I - II Low Grade Follicular Lymphoma
Secondary ID [1] 0 0
ALLG NHLLOW5
Secondary ID [2] 0 0
TROG 99.03
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Follicular 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: Drugs - Cyclophosphamide
Treatment: Other - Radiotherapy
Treatment: Drugs - Vincristine
Treatment: Drugs - Prednisolone
Treatment: Drugs - Rituximab

Experimental: Radiotherapy+ Chemotherapy - Involved field Radiotherapy (RT) 30-36 GY plus Cyclophosphamide, Vincristine and Prednisolone (CVP) + rituximab × 6 cycles

Active Comparator: Radiotherapy alone - Involved field Radiotherapy (30-36 GY) alone


Treatment: Drugs: Cyclophosphamide
1000 mg/m2 I.V. on day 1

Treatment: Other: Radiotherapy
The prescribed dose to the target volume will be 30 Gy. Daily fractions of 1.5-2.0 Gy will be employed.

Treatment: Drugs: Vincristine
1.4 mg/m2 (maximum single dose of 2 mg) I.V. on day 1

Treatment: Drugs: Prednisolone
50 mg/m2 orally daily for days 1 - 5

Treatment: Drugs: Rituximab
375 mg/m2 IV Infusion day 1

Intervention code [1] 0 0
Treatment: Drugs
Intervention code [2] 0 0
Treatment: Other
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Progression Free Survival (PFS). Period from the date of randomisation to 1st progression of disease or death from any cause.
Timepoint [1] 0 0
Main analysis after at least 3 years of follow-up following the end of accrual. An updated analysis may be done on completion of 5 years follow-up after the end of accrual. Long term follow-up analysis is planned after 10 years of follow-up
Secondary outcome [1] 0 0
Pre- and post-treatment prevalence of the t(14;18) translocation, in peripheral blood and bone marrow between arms
Timepoint [1] 0 0
Peripheral blood at commencement of treatment, after 1 year and upon relapse is collected and stored for later analysis to be done as part of translational studies when funding becomes available
Secondary outcome [2] 0 0
Overall Survival (OS) - Period from date of randomisation to date of death from any cause.
Timepoint [2] 0 0
Main analysis will be done on completion of 5 years follow-up after the end of accrual. An interim analysis to be done after at least 3 years of follow-up. A futility analysis will be performed after the 5 year analysis. In the absence of futility being
Secondary outcome [3] 0 0
Location of first relapse - Period from date of randomisation to date of first relapse location via CT scan and or other imaging as required
Timepoint [3] 0 0
Main analysis after at least 3 years of follow-up following the end of accrual. An updated analysis may be done on completion of 5 years follow-up after the end of accrual
Secondary outcome [4] 0 0
To compare time to evolution to higher histological grade - Period from date of randomisation to date of higher histological grade via CT scan and or other imaging as required
Timepoint [4] 0 0
Main analysis after at least 3 years of follow-up following the end of accrual. An updated analysis may be done on completion of 5 years follow-up after the end of accrual
Secondary outcome [5] 0 0
Freedom from progression. - Period from date of randomisation to date of first disease progression.
Timepoint [5] 0 0
Main analysis after at least 3 years of follow-up following the end of accrual. An updated analysis may be done on completion of 5 years follow-up after the end of accrual. Long term follow-up analysis is planned after 10 years of follow-up
Secondary outcome [6] 0 0
Acute and late toxicities and secondary malignances
Timepoint [6] 0 0
Frame after at least 3 years of follow-up following the end of accrual. An updated analysis may be done on completion of 5 years follow-up after the end of accrual

Eligibility
Key inclusion criteria
- Adult patients (= 18 years old) with histologically documented "follicular lymphoma,
grade 1", 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

- 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
No limit
Gender
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, chemotherapy, 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.

- Suspected or confirmed pregnancy. Must not be lactating.

- 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.

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)
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
Parallel
Other design features
Phase
Phase 3
Type of endpoint(s)
Statistical methods / analysis

Recruitment
Recruitment status
Active, not recruiting
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)
ACT,NSW,QLD,SA,TAS,VIC,WA
Recruitment hospital [1] 0 0
The Canberra Hospital - Garran
Recruitment hospital [2] 0 0
Albury Base/Murray Valley Private Hospital - Albury/Wodonga
Recruitment hospital [3] 0 0
Calvary Mater Newcastle - Newcastle
Recruitment hospital [4] 0 0
Prince of Wales Hospital - Randwick
Recruitment hospital [5] 0 0
Westmead Hospital - Wentworthville
Recruitment hospital [6] 0 0
Illawarra Cancer Care Centre - Wollongong
Recruitment hospital [7] 0 0
Radiation Oncology - Mater Centre - South Brisbane
Recruitment hospital [8] 0 0
Genesis Cancer Care (previously Premion) - Tugun
Recruitment hospital [9] 0 0
Princess Alexandra Hospital - Woolloongabba
Recruitment hospital [10] 0 0
Royal Adelaide Hospital - Adelaide
Recruitment hospital [11] 0 0
The Queen Elizabeth Hospital - Woodville
Recruitment hospital [12] 0 0
Launceston General Hospital - Launceston
Recruitment hospital [13] 0 0
St John of God Hospital - Ballarat
Recruitment hospital [14] 0 0
Peter MacCallum Cancer Centre - East Melbourne
Recruitment hospital [15] 0 0
Andrew Love Cancer Care Centre, Geelong Hospital - Geelong
Recruitment hospital [16] 0 0
Austin Health - Heidelberg
Recruitment hospital [17] 0 0
Sir Charles Gairdner Hospital - Nedlands
Recruitment postcode(s) [1] 0 0
2605 - Garran
Recruitment postcode(s) [2] 0 0
2640/3690 - Albury/Wodonga
Recruitment postcode(s) [3] 0 0
2298 - Newcastle
Recruitment postcode(s) [4] 0 0
2031 - Randwick
Recruitment postcode(s) [5] 0 0
2145 - Wentworthville
Recruitment postcode(s) [6] 0 0
2500 - Wollongong
Recruitment postcode(s) [7] 0 0
4101 - South Brisbane
Recruitment postcode(s) [8] 0 0
4224 - Tugun
Recruitment postcode(s) [9] 0 0
4102 - Woolloongabba
Recruitment postcode(s) [10] 0 0
5000 - Adelaide
Recruitment postcode(s) [11] 0 0
5011 - Woodville
Recruitment postcode(s) [12] 0 0
7250 - Launceston
Recruitment postcode(s) [13] 0 0
3350 - Ballarat
Recruitment postcode(s) [14] 0 0
3002 - East Melbourne
Recruitment postcode(s) [15] 0 0
3220 - Geelong
Recruitment postcode(s) [16] 0 0
3084 - Heidelberg
Recruitment postcode(s) [17] 0 0
6009 - Nedlands
Recruitment outside Australia
Country [1] 0 0
Canada
State/province [1] 0 0
Toronto
Country [2] 0 0
New Zealand
State/province [2] 0 0
Auckland
Country [3] 0 0
New Zealand
State/province [3] 0 0
Hamilton
Country [4] 0 0
New Zealand
State/province [4] 0 0
Wellington

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

Ethics approval
Ethics application status

Summary
Brief summary
Patients with stage I and II low grade follicular lymphoma are randomised between standard
therapy (involved field radiotherapy) and investigational therapy (involved field
radiotherapy and chemotherapy plus rituximab). The main endpoint is progression free survival
but overall survival and the influence of t(14;18) status will also be studied.
Trial website
https://clinicaltrials.gov/show/NCT00115700
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Michael MacManus, MD
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
Other publications