Chemotherapy and Radiotherapy for Osteolymphoma

Osteolymphoma Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00141648
• Other study ID #: TROG 99.04
• Secondary ID: ALLG LY-02
• Status: Completed
• Phase: N/A
• First received: August 30, 2005
• Last updated: September 29, 2009
• Start date: September 2000
• Est. completion date: February 2008

Study information

• Verified date: September 2009
• Source: Trans-Tasman Radiation Oncology Group (TROG)
• Contact: n/a
• Is FDA regulated: No
• Health authority: Australia: Human Research Ethics Committee
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 70
• Est. completion date: February 2008
• Est. primary completion date: February 2007
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 17 Years and older

Eligibility

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

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Osteolymphoma

Intervention

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

Radiation:
• Radiotherapy
Total 45 Gy in 25 fractions

Locations

Country	Name	City	State
Australia	Royal Adelaide Hospital	Adelaide	South Australia
Australia	The Wesley Radiation Oncology Pty Ltd	Auchenflower	Queensland
Australia	Royal Prince Alfred Hospital	Camperdown	New South Wales
Australia	Peter MacCallum Cancer Centre	East Melbourne	Victoria
Australia	Andrew Love Cancer Care Centre, Geelong Hospital	Geelong	Victoria
Australia	Royal Brisbane Hospital	Herston	Queensland
Australia	Royal Hobart Hospital	Hobart	Tasmania
Australia	Launceston General Hospital	Launceston	Tasmania
Australia	Liverpool Hospital	Liverpool	New South Wales
Australia	Sir Charles Gairdner Hospital	Nedlands	Western Australia
Australia	Calvary Mater Newcastle	Newcastle	New South Wales
Australia	Mater QRI	South Brisbane	Queensland
Australia	North Queensland Oncology Service	Townsville	Queensland
Australia	East Coast Cancer Centre, John Flynn Hospital	Tugun	Queensland
Australia	Westmead Hospital	Wentworthville	New South Wales
Australia	Wollongong Hospital	Wollongong	New South Wales
Australia	Princess Alexandra Hospital	Woolloongabba	Queensland
New Zealand	Auckland Hospital	Auckland
New Zealand	Waikato Hospital	Hamilton
New Zealand	Palmerston North Hospital	Palmerston North

Sponsors (4)

Lead Sponsor	Collaborator
Trans-Tasman Radiation Oncology Group (TROG)	Australasian Leukaemia and Lymphoma Group, Australasian Radiation Oncology Lymphoma Group, Wesley Research Institute

Countries where clinical trial is conducted

Australia,  New Zealand, 

References & Publications (2)

Christie D, Le T, Watling K, Cornes D, O'Brien P, Hitchins R. Quality assurance audit: a prospective non-randomised trial of chemotherapy and radiotherapy for osteolymphoma (TROG 99.04/ALLG LY02). J Med Imaging Radiat Oncol. 2009 Apr;53(2):203-6. doi: 10. — View Citation

Christie DR, Gabriel GS, Dear K. Adverse effects of a multicentre system for ethics approval on the progress of a prospective multicentre trial of cancer treatment: how many patients die waiting? Intern Med J. 2007 Oct;37(10):680-6. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Overall Survival. The time from registration to the date of death		Main analysis when accrual is complete at approx. 10 years.	No
Secondary	Time to local or regional failure. Measured from registration.		Main analysis when accrual is complete at approx. 10 years.	No
Secondary	Pathological fracture rate. Measured from registration.		Main analysis when accrual is complete at approx. 10 years.	Yes

External Links

•   Click here for more information about this study on the TROG official website