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Completed

NCT Number: NCT00141648

Chemotherapy and Radiotherapy for Osteolymphoma

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.

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Key information

Conditions

Osteolymphoma Hemic and Lymphatic Diseases Immune System Diseases Immunoproliferative Disorders Lymphatic Diseases Lymphoma Lymphoproliferative Disorders Neoplasms Neoplasms by Histologic Type

Age range

17 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Royal Prince Alfred Hospital, Camperdown, New South Wales, Australia

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Cyclophosphamide, Doxorubicin, Vincristine, Prednisolone.

Drug

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

Other names: Endoxan, Caelyx, Vincristine sulfate injection, Predsone

Radiotherapy

Radiation

Total 45 Gy in 25 fractions

Other names: Radiation

Primary outcomes

  1. Overall Survival. The time from registration to the date of death

    Time frame: Main analysis when accrual is complete at approx. 10 years.

Secondary outcomes

  1. Time to local or regional failure. Measured from registration.

    Time frame: Main analysis when accrual is complete at approx. 10 years.

  2. Pathological fracture rate. Measured from registration.

    Time frame: Main analysis when accrual is complete at approx. 10 years.

Sponsors and collaborators

Lead sponsor

Trans Tasman Radiation Oncology Group

Other

Collaborators

  • Australasian Leukaemia and Lymphoma Group
  • Australasian Radiation Oncology Lymphoma Group
  • Wesley Research Institute

Registry information

Official study title

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

Important dates

Study start
2000
Primary completion
2007
Study completion
2008
First posted
Sep 1, 2005
Registry last updated
Oct 1, 2009

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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