Chemotherapy and Radiotherapy for Osteolymphoma

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

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00141648

Enrollment

Registered

2005-09-01

Start date

2000-09-30

Completion date

2008-02-29

Last updated

2009-10-01

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Osteolymphoma

Keywords

Osteolymphoma, Chemotherapy, Radiotherapy, Lymphoma

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.

Interventions

DRUGCyclophosphamide, Doxorubicin, Vincristine, Prednisolone.

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

RADIATIONRadiotherapy

Total 45 Gy in 25 fractions

Study design

Allocation

NON_RANDOMIZED

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

17 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

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

Secondary

Measure	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.

Countries

Australia, New Zealand

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026