Chemotherapy and Radiotherapy for Osteolymphoma

Not Applicable

Completed

• Conditions: Osteolymphoma
• Interventions: Drug: Cyclophosphamide, Doxorubicin, Vincristine, Prednisolone.; Radiation: Radiotherapy

• Registration Number: NCT00141648
• Lead Sponsor: Trans Tasman Radiation Oncology Group

Brief Summary

This trial is intended to determine the results obtained when standard treatment for Non Hodgkin's lymphoma is applied to the disease in a rare subtype which arises in bone. Patients in the study undergo a detailed assessment, then treatment with chemotherapy and radiotherapy, followed by close monitoring.

Detailed Description

Patients with non-Hodgkin's lymphoma arising primarily in bone have been studied using a number of different names making literature searching difficult. The term Osteolymphoma has been proposed to make searching easier in the future. Patients in this study undergoing staging which includes isotope bone scanning and PET scanning where available. Eligible patients then undergo treatment with three cycles of CHOP chemotherapy at conventional doses and shrinking field radiotherapy to a total of 45 Gy. Monoclonal antibodies are not included as good results have been obtained without using them. After treatment the patients are regularly monitored. The trial is presented twice per year at the meetings of TROG, ALLG and AROLG.

Study Timeline

• Study Start: 2000-09
• Study First Submitted: 2005-08-30
• Study First Submitted QC: 2005-08-30
• Study First Posted: 2005-09-01
• Primary Completion: 2007-02
• Study Completion: 2008-02
• Status Verified: 2009-09
• Last Update Submitted: 2009-09-29
• Last Update Posted: 2009-10-01

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 70

Inclusion Criteria

• Histologically confirmed non-Hodgkin's lymphoma in a bony site
• Limited extraosseous disease
• Ann Arbor stage IE
• Age >17
• ECOG performance status <3
• Expected survival > 6 months
• Patients capable of childbearing are using adequate contraception.
• Written informed consent

Exclusion Criteria

• Previous radiotherapy
• Previous malignancy
• Medically unfit to undergo treatment

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
1	Radiotherapy	Chemotherapy followed by radiotherapy to begin 3 weeks after the last cycle.
1	Cyclophosphamide, Doxorubicin, Vincristine, Prednisolone.	Chemotherapy followed by radiotherapy to begin 3 weeks after the last cycle.

Primary Outcome Measures

Name	Time	Method
Overall Survival. The time from registration to the date of death	Main analysis when accrual is complete at approx. 10 years.

Secondary Outcome Measures

Name	Time	Method
Time to local or regional failure. Measured from registration.	Main analysis when accrual is complete at approx. 10 years.
Pathological fracture rate. Measured from registration.	Main analysis when accrual is complete at approx. 10 years.

Trial Locations

Locations (20)

Royal Prince Alfred Hospital; 🇦🇺 Camperdown, New South Wales, Australia

Liverpool Hospital; 🇦🇺 Liverpool, New South Wales, Australia

Calvary Mater Newcastle; 🇦🇺 Newcastle, New South Wales, Australia

Westmead Hospital; 🇦🇺 Wentworthville, New South Wales, Australia

Wollongong Hospital; 🇦🇺 Wollongong, New South Wales, Australia

The Wesley Radiation Oncology Pty Ltd; 🇦🇺 Auchenflower, Queensland, Australia

Royal Brisbane Hospital; 🇦🇺 Herston, Queensland, Australia

Mater QRI; 🇦🇺 South Brisbane, Queensland, Australia

North Queensland Oncology Service; 🇦🇺 Townsville, Queensland, Australia

East Coast Cancer Centre, John Flynn Hospital; 🇦🇺 Tugun, Queensland, Australia

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