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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register.

Register:	ANZCTR
Last refreshed on:	13 January 2020
Main ID:	ACTRN12607000112460
Date of registration:	14/07/2000
Prospective Registration:	No
Primary sponsor:	Michael MacManus
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
Date of first enrolment:	14/02/2000
Target sample size:	150
Recruitment status:	Active, not recruiting
URL:	https://anzctr.org.au/ACTRN12607000112460.aspx
Study type:	Interventional
Study design:	Purpose: Treatment; Allocation: Randomised controlled trial; Masking: Open (masking not used);Assignment: Parallel;Type of endpoint: Efficacy;
Phase:	Phase 3

Countries of recruitment
Australia	Canada	New Zealand

Contacts

Name:	A/Prof Michael MacManus
Address:	Peter MacCallum Cancer Centre Department of Radiation Oncology Locked Bag 1 A'Beckett Street VIC 8006 Australia
Telephone:	+61 3 9656 1111
Email:	Michael.MacManus@petermac.org
Affiliation:

Name:	Ms Bev McClure
Address:	Peter MacCallum Cancer Centre Department of Radiation Oncology Locked Bag 1 A'Beckett Street VIC 8006 Australia
Telephone:	+61 3 9656 1266
Email:	Bev.McClure@petermac.org
Affiliation:

Key inclusion & exclusion criteria

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.
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.

Age minimum: 18 Years
Age maximum: Not stated
Gender: Both males and females

Health Condition(s) or Problem(s) studied

Cancer - Lymphoma (non Hodgkin's lymphoma) - Low grade lymphoma

Stage I-II low grade follicular lymphoma;
Stage I-II low grade follicular lymphoma

Intervention(s)

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.

Primary Outcome(s)

Progression free survival. Period from date of randomisation to first progression of disease or death from any cause.[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(s)

1. Pre- and post-treatment prevalence of the t(14;18) translocation in peripheral blood and bone marrow between arms.[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. ]

3. Location of first relapse. If it is nodal, extranodal or systemic.[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. ]

4. Time to histologic progression. [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.]

2. Overall survival.[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 ID(s)

National Clinical Trials Registry: NCTR325

The Australasian Leukaemia and Lymphoma Group: ALLG NHLLOW5

ClinicalTrials.gov: NCT00115700

Source(s) of Monetary Support

AMGEN

Cancer Council Victoria

Secondary Sponsor(s)

Trans Tasman Radiation Oncology Group (TROG)

Ethics review

Status: Approved
Approval date:
Contact:

Austin Hospital