A Phase 3 interventional study of Cyclophosphamide and Radiotherapy in Follicular Lymphoma, sponsored by Trans Tasman Radiation Oncology Group. Completed at 21 sites in 3 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2022-11-18.
Sponsored by Trans Tasman Radiation Oncology Group · Phase 3, Interventional, and Treatment
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.
Radiotherapy is the only modality which has been proven to have curative potential in patients with localised low grade lymphoma. Despite excellent control of the local tumour, most patients relapse outside the area treated with radiation and most of these ultimately die from lymphoma. This study tests the hypothesis that the addition of six cycles of chemotherapy plus rituximab (systemic chemotherapy) can eradicate undetectable lymphoma deposits outside the radiation field and thereby improve the cure rate. The study will specifically test the hypothesis that six cycles of adjuvant CVP chemotherapy (cyclophosphamide, vincristine, prednisolone) in combination with Rituximab will improve progression-free survival for patients with stage I and II low-grade follicular lymphoma treated with involved-field radiotherapy (IFRT). That is, will patients given radiotherapy plus systemic chemotherapy live longer or remain free from disease longer than patients treated with radiation alone? Radiotherapy alone is widely regarded as the standard treatment for this disease.
There are a number of secondary endpoints to the study, as follows:
5,578 studies on the registry are indexed under Lymphoma; 825 are open to participants now.
This study's enrollment of 150 is above the median of 40 across 4,508 interventional studies indexed under Lymphoma.
Browse Lymphoma studies →Trans Tasman Radiation Oncology Group is the lead sponsor of 34 studies on the registry; 1 is open to participants now.
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Exclusion Criteria:
Involved field Radiotherapy (RT) 30-36 GY plus Cyclophosphamide, Vincristine and Prednisolone (CVP) + rituximab × 6 cycles
Drug: Cyclophosphamide · Radiation: Radiotherapy · Drug: Vincristine · Drug: Prednisolone · Drug: Rituximab
Involved field Radiotherapy (30-36 GY) alone
Radiation: Radiotherapy
1000 mg/m2 I.V. on day 1
Also known as: Cycloblastin, Endoxan
The prescribed dose to the target volume will be 30 Gy. Daily fractions of 1.5-2.0 Gy will be employed.
Also known as: Radiation
1.4 mg/m2 (maximum single dose of 2 mg) I.V. on day 1
Also known as: Vincristine Sulfate Injection
50 mg/m2 orally daily for days 1 - 5
Also known as: Panafcort, Panafcortelone, Predsone, Predsolone
375 mg/m2 IV Infusion day 1
Also known as: Erbitux, Mabthera
Progression Free Survival (PFS). Period from the date of randomisation to 1st progression of disease or death from any cause.
Time frame: 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
Pre- and post-treatment prevalence of the t(14;18) translocation, in peripheral blood and bone marrow between arms
Time frame: 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
Overall Survival (OS)
Period from date of randomisation to date of death from any cause.
Time frame: 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
Location of first relapse
Period from date of randomisation to date of first relapse location via CT scan and or other imaging as required
Time frame: 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
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
Time frame: 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
Freedom from progression.
Period from date of randomisation to date of first disease progression.
Time frame: 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
Acute and late toxicities and secondary malignances
Time frame: 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
This study is completed, as verified in Nov 2022. You cannot join it, but the record below documents what was studied.
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Trans Tasman Radiation Oncology Group