OsteolymphomaNCT00141648
Chemotherapy and Radiotherapy for Osteolymphoma
A study testing Cyclophosphamide, Doxorubicin, Vincristine, Prednisolone. and Radiotherapy in people with Osteolymphoma, run by Trans Tasman Radiation Oncology Group at 20 sites in 2 countries.
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. Read more about this study
- Who is it for?
- Ages 17 years and older
- Conditions the study is for
- Osteolymphoma
- What is being tested?
- Cyclophosphamide, Doxorubicin, Vincristine, Prednisolone. and Radiotherapy
- Type of treatment
- Pill or oral medicine, Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 70 participants
- Where
- 20 sitesin 2 countries
- Study dates
- Sep 2000to Feb 2008
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 17 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Previous radiotherapy
- Previous malignancy
- Medically unfit to undergo treatment
Trial locations and contacts
20 sites in 2 countries.
20 sites in 2 countries
Australia17 sites
Royal Adelaide Hospital
Adelaide, South Australia, 5000
The Wesley Radiation Oncology Pty Ltd
Auchenflower, Queensland, 4006
Royal Prince Alfred Hospital
Camperdown, New South Wales, 2050
Peter MacCallum Cancer Centre
East Melbourne, Victoria, 3002
Andrew Love Cancer Care Centre, Geelong Hospital
Geelong, Victoria, 3220
Royal Brisbane Hospital
Herston, Queensland, 4029
Royal Hobart Hospital
Hobart, Tasmania, 7000
Launceston General Hospital
Launceston, Tasmania, 7250
Liverpool Hospital
Liverpool, New South Wales, 1871
Sir Charles Gairdner Hospital
Nedlands, Western Australia, 6009
Calvary Mater Newcastle
Newcastle, New South Wales, 2310
Mater QRI
South Brisbane, Queensland, 4101
North Queensland Oncology Service
Townsville, Queensland, 4810
East Coast Cancer Centre, John Flynn Hospital
Tugun, Queensland, 4224
Westmead Hospital
Wentworthville, New South Wales, 2145
Wollongong Hospital
Wollongong, New South Wales
Princess Alexandra Hospital
Woolloongabba, Queensland, 4102
New Zealand3 sites
Auckland Hospital
Auckland, 1001
Waikato Hospital
Hamilton, 3200
Palmerston North Hospital
Palmerston North
About this study
Official title: A Prospective Non-randomised Trial of 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.
Read the 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.
- Conditions
- Osteolymphoma
- Being tested
- Cyclophosphamide, Doxorubicin, Vincristine, Prednisolone., Radiotherapy
- Keywords
- Osteolymphoma, Chemotherapy, Radiotherapy, Lymphoma
- Medical subject headings
- Lymphoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cyclophosphamide, Doxorubicin, Vincristine, Prednisolone.Drug
Also called Endoxan, Caelyx, Vincristine sulfate injection, Predsone
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
RadiotherapyRadiation
Also called Radiation
Total 45 Gy in 25 fractions
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Chemotherapy followed by radiotherapy to begin 3 weeks after the last cycle. Receives: Drug: Cyclophosphamide, Doxorubicin, Vincristine, Prednisolone.; Radiation: Radiotherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Overall Survival. The time from registration to the date of death
Measured: Main analysis when accrual is complete at approx. 10 years.
Secondary outcomes (2)
Time to local or regional failure. Measured from registration.
Measured: Main analysis when accrual is complete at approx. 10 years.
Pathological fracture rate. Measured from registration.
Measured: Main analysis when accrual is complete at approx. 10 years.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Sep 2005 (estimated)
- Study startSep 2000
- Primary completionFeb 2007
- Study completionFeb 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for OsteolymphomaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 70 participants (actual)
Sponsor and investigators
- Lead sponsor
- Trans Tasman Radiation Oncology Group
- Sponsor type
- University, hospital or other
- Collaborators
- Australasian Leukaemia and Lymphoma Group, Australasian Radiation Oncology Lymphoma Group, Wesley Research Institute
- Investigators
- David Christie, FRANZCR, Study chair, East Coasr Cancer Centre
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00141648
- Sponsor's protocol ID
- TROG 99.04
- Other IDs
- ALLG LY-02
- Status last verified
- Sep 2009
- First submitted
- 30 Aug 2005
- Last updated
- 1 Oct 2009
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 17894765Christie 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.
PubMed 19527368Christie 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.
PubMed 20638196
Study at a glance
From the registry record, last updated by the sponsor on 1 Oct 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective Non-randomised Trial of Chemotherapy and Radiotherapy for Osteolymphoma
- ClinicalTrials.gov ID
- NCT00141648
- Acronym / sponsor ID
- TROG 99.04
- Conditions
- Osteolymphoma
- Keywords
- Osteolymphoma, Chemotherapy, Radiotherapy, Lymphoma
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 70 participants (actual)
- Lead sponsor
- Trans Tasman Radiation Oncology GroupUniversity, hospital or other
- Collaborators
- Australasian Leukaemia and Lymphoma Group, Australasian Radiation Oncology Lymphoma Group, Wesley Research Institute
- Study start
- Sep 2000
- Primary completion
- Feb 2007 (actual)
- Study completion
- Feb 2008 (actual)
- First posted
- 1 Sep 2005 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Drug: Cyclophosphamide, Doxorubicin, Vincristine, Prednisolone., Radiation: RadiotherapyChemotherapy followed by radiotherapy to begin 3 weeks after the last cycle. |
Who may qualify
- Ages
- 17 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (8 listed)
- Histologically confirmed non-Hodgkin's lymphoma in a bony site
- Limited extraosseous disease
- Ann Arbor stage IE
- Age >17
- ECOG performance status <3
Key exclusion criteria (3 listed)
- Previous radiotherapy
- Previous malignancy
- Medically unfit to undergo treatment
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Cyclophosphamide, Doxorubicin, Vincristine, Prednisolone.Also: Endoxan, Caelyx, Vincristine sulfate injection, PredsoneGiven 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 | Drug | 1 |
| RadiotherapyAlso: RadiationTotal 45 Gy in 25 fractions | Radiation | 1 |
Primary outcome
Overall Survival. The time from registration to the date of death
Time frame: Main analysis when accrual is complete at approx. 10 years.
2 secondary outcomes
Time to local or regional failure. Measured from registration.
Time frame: Main analysis when accrual is complete at approx. 10 years.
Pathological fracture rate. Measured from registration.
Time frame: Main analysis when accrual is complete at approx. 10 years.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Oct 2009.
- Background: PubMed 17894765Christie 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.
- Results publication: PubMed 19527368Christie 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.
- Derived from this study: PubMed 20638196Christie 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.
- Click here for more information about this study on the TROG official websiteLink provided by the sponsor.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
David Christie, FRANZCR study chair
East Coasr Cancer Centre
20 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Cyclophosphamide, Doxorubicin, Vincristine, Prednisolone. and Radiotherapy in people with Osteolymphoma, run by Trans Tasman Radiation Oncology Group at 20 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 1 Oct 2009. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 20 sites in Australia, New Zealand. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Overall Survival. The time from registration to the date of death (time frame: Main analysis when accrual is complete at approx. 10 years.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00141648, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Oct 2009.