Chemotherapy and Radiotherapy for Osteolymphoma

Study Overview
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Brief Summary
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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
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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.

Official Title
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A Prospective Non-randomised Trial of Chemotherapy and Radiotherapy for Osteolymphoma

Conditions
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Osteolymphoma

Intervention / Treatment
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* Drug: Cyclophosphamide, Doxorubicin, Vincristine, Prednisolone.
* Radiation: Radiotherapy


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 17 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br>Chemotherapy followed by radiotherapy to begin 3 weeks after the last cycle. | Drug: Cyclophosphamide, Doxorubicin, Vincristine, Prednisolone.<br>* Given intravenously on days 1,11,43: Cyclophosphamide 750mg/m2, doxorubicin 50mg/m2, vincristine 1.4mg/m2. Given orally on days 1-5,22-27: Pednisolone 50mg/m2<br>* Other names: Endoxan, Caelyx, Vincristine sulfate injection, Predsone;Radiation: Radiotherapy<br>* Total 45 Gy in 25 fractions<br>* Other names: Radiation;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Overall Survival. The time from registration to the date of death |  | Main analysis when accrual is complete at approx. 10 years. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Osteolymphoma, Chemotherapy, Radiotherapy, Lymphoma