Chemotherapy and Radiotherapy for Osteolymphoma

This study has been completed.
Sponsor:
Collaborators:
Australasian Leukaemia and Lymphoma Group
Australasian Radiation Oncology Lymphoma Group
Wesley Research Institute
Information provided by:
Trans-Tasman Radiation Oncology Group (TROG)
ClinicalTrials.gov Identifier:
NCT00141648
First received: August 30, 2005
Last updated: September 29, 2009
Last verified: September 2009
  Purpose

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.


Condition Intervention
Osteolymphoma
Drug: Cyclophosphamide, Doxorubicin, Vincristine, Prednisolone.
Radiation: Radiotherapy

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Prospective Non-randomised Trial of Chemotherapy and Radiotherapy for Osteolymphoma

Resource links provided by NLM:


Further study details as provided by Trans-Tasman Radiation Oncology Group (TROG):

Primary Outcome Measures:
  • Overall Survival. The time from registration to the date of death [ Time Frame: Main analysis when accrual is complete at approx. 10 years. ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Time to local or regional failure. Measured from registration. [ Time Frame: Main analysis when accrual is complete at approx. 10 years. ] [ Designated as safety issue: No ]
  • Pathological fracture rate. Measured from registration. [ Time Frame: Main analysis when accrual is complete at approx. 10 years. ] [ Designated as safety issue: Yes ]

Enrollment: 70
Study Start Date: September 2000
Study Completion Date: February 2008
Primary Completion Date: February 2007 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
Chemotherapy followed by radiotherapy to begin 3 weeks after the last cycle.
Drug: Cyclophosphamide, 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
Other Name: Endoxan, Caelyx, Vincristine sulfate injection, Predsone
Radiation: Radiotherapy
Total 45 Gy in 25 fractions
Other Name: Radiation

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.

  Eligibility

Ages Eligible for Study:   17 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00141648

Locations
Australia, New South Wales
Royal Prince Alfred Hospital
Camperdown, New South Wales, Australia, 2050
Liverpool Hospital
Liverpool, New South Wales, Australia, 1871
Calvary Mater Newcastle
Newcastle, New South Wales, Australia, 2310
Westmead Hospital
Wentworthville, New South Wales, Australia, 2145
Wollongong Hospital
Wollongong, New South Wales, Australia
Australia, Queensland
The Wesley Radiation Oncology Pty Ltd
Auchenflower, Queensland, Australia, 4006
Royal Brisbane Hospital
Herston, Queensland, Australia, 4029
Mater QRI
South Brisbane, Queensland, Australia, 4101
North Queensland Oncology Service
Townsville, Queensland, Australia, 4810
East Coast Cancer Centre, John Flynn Hospital
Tugun, Queensland, Australia, 4224
Princess Alexandra Hospital
Woolloongabba, Queensland, Australia, 4102
Australia, South Australia
Royal Adelaide Hospital
Adelaide, South Australia, Australia, 5000
Australia, Tasmania
Royal Hobart Hospital
Hobart, Tasmania, Australia, 7000
Launceston General Hospital
Launceston, Tasmania, Australia, 7250
Australia, Victoria
Peter MacCallum Cancer Centre
East Melbourne, Victoria, Australia, 3002
Andrew Love Cancer Care Centre, Geelong Hospital
Geelong, Victoria, Australia, 3220
Australia, Western Australia
Sir Charles Gairdner Hospital
Nedlands, Western Australia, Australia, 6009
New Zealand
Auckland Hospital
Auckland, New Zealand, 1001
Waikato Hospital
Hamilton, New Zealand, 3200
Palmerston North Hospital
Palmerston North, New Zealand
Sponsors and Collaborators
Trans-Tasman Radiation Oncology Group (TROG)
Australasian Leukaemia and Lymphoma Group
Australasian Radiation Oncology Lymphoma Group
Wesley Research Institute
Investigators
Study Chair: David Christie, FRANZCR East Coasr Cancer Centre
  More Information

Additional Information:
Publications:
Christie D, Le T, Watling K, Cornes D, O'Brien P, Hitchins R. Quality assurance audit: A proposepctive non-randomised trial of chemotherapy and radiotherapy for osteolymphoma (TROG 99.04/ALLG LY02). Journal of Medical Imaging and Radiation Oncology. 53; 2:203-206, 2009

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Associate Professor David Christie, Trans Tasman Radiation Oncology Group (TROG)
ClinicalTrials.gov Identifier: NCT00141648     History of Changes
Other Study ID Numbers: TROG 99.04, ALLG LY-02
Study First Received: August 30, 2005
Last Updated: September 29, 2009
Health Authority: Australia: Human Research Ethics Committee

Keywords provided by Trans-Tasman Radiation Oncology Group (TROG):
Osteolymphoma
Chemotherapy
Radiotherapy
Lymphoma

Additional relevant MeSH terms:
Cyclophosphamide
Liposomal doxorubicin
Doxorubicin
Prednisolone
Methylprednisolone Hemisuccinate
Vincristine
Methylprednisolone acetate
Prednisolone acetate
Methylprednisolone
Prednisolone hemisuccinate
Prednisolone phosphate
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Pharmacologic Actions
Antirheumatic Agents
Therapeutic Uses
Antineoplastic Agents, Alkylating
Alkylating Agents
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Myeloablative Agonists
Antibiotics, Antineoplastic
Topoisomerase II Inhibitors
Topoisomerase Inhibitors
Enzyme Inhibitors
Anti-Inflammatory Agents
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists

ClinicalTrials.gov processed this record on July 31, 2014