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Brief Title: Radiotherapy Versus Radiotherapy Plus Chemotherapy in Early Stage Follicular Lymphoma
Official 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
Study ID: NCT00115700
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.
Detailed Description: 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: 1. Comparison the pre- and post-treatment prevalence of the t(14:18) translocation, in peripheral blood and bone marrow, of patients treated with either IFRT alone or IFRT plus chemotherapy. This translocation is potentially a marker for minimal residual disease and eradication of the marker from blood cells may have prognostic implications. The clinical value of "molecular remission" as an early predictor of freedom from progression (FFP) and survival will be assessed. 2. Comparison of overall survival and FFP for patients treated with IFRT alone with overall survival and FFP for patients treated with combined IFRT and systemic therapy. Delay of progression of disease may be of limited value if overall survival is the same. 3. Comparison of acute and late toxicity and second malignancy rates for patients treated with IFRT or IFRT plus systemic therapy. 4. Delineation of the location of first relapse in relation to radiation therapy fields.
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
The Canberra Hospital, Garran, Australian Capital Territory, Australia
Calvary Mater Newcastle, Newcastle, New South Wales, Australia
Prince of Wales Hospital, Randwick, New South Wales, Australia
Westmead Hospital, Wentworthville, New South Wales, Australia
Albury Base/Murray Valley Private Hospital, West Albury, New South Wales, Australia
Illawarra Cancer Care Centre, Wollongong, New South Wales, Australia
Radiation Oncology - Mater Centre, South Brisbane, Queensland, Australia
Genesis Cancer Care (previously Premion), Tugun, Queensland, Australia
Princess Alexandra Hospital, Woolloongabba, Queensland, Australia
Royal Adelaide Hospital, Adelaide, South Australia, Australia
The Queen Elizabeth Hospital, Woodville, South Australia, Australia
Launceston General Hospital, Launceston, Tasmania, Australia
St John of God Hospital, Ballarat, Victoria, Australia
Peter MacCallum Cancer Centre, East Melbourne, Victoria, Australia
Andrew Love Cancer Care Centre, Geelong Hospital, Geelong, Victoria, Australia
Austin Health, Heidelberg, Victoria, Australia
Sir Charles Gairdner Hospital, Nedlands, Western Australia, Australia
Princess Margaret Hospital, Toronto, , Canada
Auckland Hospital, Auckland, , New Zealand
Waikato Hospital, Hamilton, , New Zealand
Wellington Hospital, Wellington, , New Zealand
Name: Michael MacManus, MD
Affiliation: Peter MacCallum Cancer Centre, Australia
Role: STUDY_CHAIR