Clinical trial NCT00141648: Chemotherapy and Radiotherapy for Osteolymphoma
Official title: A Prospective Non-randomised Trial of Chemotherapy and Radiotherapy for Osteolymphoma
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Osteolymphoma
Keywords: Osteolymphoma
Chemotherapy
Radiotherapy
Lymphoma
Lead sponsor: Trans Tasman Radiation Oncology Group
Sponsor class: OTHER
Collaborators: name: Australasian Leukaemia and Lymphoma Group
name: Australasian Radiation Oncology Lymphoma Group
name: Wesley Research Institute
First posted: 2005-09-01
Enrollment: 70
Sex: ALL
Minimum age (years): 17
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

Eligibility 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

Primary outcomes:
measure: Overall Survival. The time from registration to the date of death
timeFrame: Main analysis when accrual is complete at approx. 10 years.
Secondary outcomes:
measure: Time to local or regional failure. Measured from registration.
timeFrame: Main analysis when accrual is complete at approx. 10 years.
measure: Pathological fracture rate. Measured from registration.
timeFrame: Main analysis when accrual is complete at approx. 10 years.
Other outcomes:
Locations:
city: Camperdown
country: Australia
facility: Royal Prince Alfred Hospital
state: New South Wales
city: Liverpool
country: Australia
facility: Liverpool Hospital
state: New South Wales
city: Newcastle
country: Australia
facility: Calvary Mater Newcastle
state: New South Wales
city: Wentworthville
country: Australia
facility: Westmead Hospital
state: New South Wales
city: Wollongong
country: Australia
facility: Wollongong Hospital
state: New South Wales
city: Auchenflower
country: Australia
facility: The Wesley Radiation Oncology Pty Ltd
state: Queensland
city: Herston
country: Australia
facility: Royal Brisbane Hospital
state: Queensland
city: South Brisbane
country: Australia
facility: Mater QRI
state: Queensland
city: Townsville
country: Australia
facility: North Queensland Oncology Service
state: Queensland
city: Tugun
country: Australia
facility: East Coast Cancer Centre, John Flynn Hospital
state: Queensland
city: Woolloongabba
country: Australia
facility: Princess Alexandra Hospital
state: Queensland
city: Adelaide
country: Australia
facility: Royal Adelaide Hospital
state: South Australia
city: Hobart
country: Australia
facility: Royal Hobart Hospital
state: Tasmania
city: Launceston
country: Australia
facility: Launceston General Hospital
state: Tasmania
city: East Melbourne
country: Australia
facility: Peter MacCallum Cancer Centre
state: Victoria
city: Geelong
country: Australia
facility: Andrew Love Cancer Care Centre, Geelong Hospital
state: Victoria
city: Nedlands
country: Australia
facility: Sir Charles Gairdner Hospital
state: Western Australia
city: Auckland
country: New Zealand
facility: Auckland Hospital
city: Hamilton
country: New Zealand
facility: Waikato Hospital
city: Palmerston North
country: New Zealand
facility: Palmerston North Hospital
Study officials:
affiliation: East Coasr Cancer Centre
name: David Christie, FRANZCR
role: STUDY_CHAIR
References:
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. doi: 10.1111/j.1445-5994.2007.01451.x.
citation: 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: 10.1111/j.1754-9485.2009.02054.x.
citation: Christie D, Dear K, Le T, Barton M, Wirth A, Porter D, Roos D, Pratt G. Limited chemotherapy and shrinking field radiotherapy for Osteolymphoma (primary bone lymphoma): results from the trans-Tasman Radiation Oncology Group 99.04 and Australasian Leukaemia and Lymphoma Group LY02 prospective trial. Int J Radiat Oncol Biol Phys. 2011 Jul 15;80(4):1164-70. doi: 10.1016/j.ijrobp.2010.03.036. Epub 2010 Jul 16.