Chemotherapy and Radiotherapy for Osteolymphoma

NCT ID: NCT00141648

Last Updated: 2009-10-01

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

70 participants

Study Classification

INTERVENTIONAL

Study Start Date

2000-09-30

Study Completion Date

2008-02-29

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Osteolymphoma

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

1

Chemotherapy followed by radiotherapy to begin 3 weeks after the last cycle.

Group Type EXPERIMENTAL

Cyclophosphamide, Doxorubicin, Vincristine, Prednisolone.

Intervention Type 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

Radiotherapy

Intervention Type RADIATION

Total 45 Gy in 25 fractions

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

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

Intervention Type DRUG

Radiotherapy

Total 45 Gy in 25 fractions

Intervention Type RADIATION

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

Endoxan, Caelyx, Vincristine sulfate injection, Predsone Radiation

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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
Minimum Eligible Age

17 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Australasian Leukaemia and Lymphoma Group

OTHER

Sponsor Role collaborator

Australasian Radiation Oncology Lymphoma Group

OTHER

Sponsor Role collaborator

Wesley Research Institute

OTHER

Sponsor Role collaborator

Trans Tasman Radiation Oncology Group

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Trans Tasman Radiation Oncology Group (TROG)

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

David Christie, FRANZCR

Role: STUDY_CHAIR

East Coasr Cancer Centre

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Royal Prince Alfred Hospital

Camperdown, New South Wales, Australia

Site Status

Liverpool Hospital

Liverpool, New South Wales, Australia

Site Status

Calvary Mater Newcastle

Newcastle, New South Wales, Australia

Site Status

Westmead Hospital

Wentworthville, New South Wales, Australia

Site Status

Wollongong Hospital

Wollongong, New South Wales, Australia

Site Status

The Wesley Radiation Oncology Pty Ltd

Auchenflower, Queensland, Australia

Site Status

Royal Brisbane Hospital

Herston, Queensland, Australia

Site Status

Mater QRI

South Brisbane, Queensland, Australia

Site Status

North Queensland Oncology Service

Townsville, Queensland, Australia

Site Status

East Coast Cancer Centre, John Flynn Hospital

Tugun, Queensland, Australia

Site Status

Princess Alexandra Hospital

Woolloongabba, Queensland, Australia

Site Status

Royal Adelaide Hospital

Adelaide, South Australia, Australia

Site Status

Royal Hobart Hospital

Hobart, Tasmania, Australia

Site Status

Launceston General Hospital

Launceston, Tasmania, Australia

Site Status

Peter MacCallum Cancer Centre

East Melbourne, Victoria, Australia

Site Status

Andrew Love Cancer Care Centre, Geelong Hospital

Geelong, Victoria, Australia

Site Status

Sir Charles Gairdner Hospital

Nedlands, Western Australia, Australia

Site Status

Auckland Hospital

Auckland, , New Zealand

Site Status

Waikato Hospital

Hamilton, , New Zealand

Site Status

Palmerston North Hospital

Palmerston North, , New Zealand

Site Status

Countries

Review the countries where the study has at least one active or historical site.

Australia New Zealand

References

Explore related publications, articles, or registry entries linked to this study.

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.

Reference Type BACKGROUND
PMID: 17894765 (View on PubMed)

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.

Reference Type RESULT
PMID: 19527368 (View on PubMed)

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.

Reference Type DERIVED
PMID: 20638196 (View on PubMed)

Related Links

Access external resources that provide additional context or updates about the study.

http://www.trog.com.au

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

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

ALLG LY-02

Identifier Type: -

Identifier Source: secondary_id

TROG 99.04

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.