Chemotherapy and Radiotherapy for Osteolymphoma
Overview[ - collapse ][ - ]
| 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 | Osteolymphoma |
| Intervention | Drug: Cyclophosphamide, Doxorubicin, Vincristine, Prednisolone. Radiation: Radiotherapy |
| Phase | N/A |
| Sponsor | Trans-Tasman Radiation Oncology Group (TROG) |
| Responsible Party | Trans-Tasman Radiation Oncology Group (TROG) |
| ClinicalTrials.gov Identifier | NCT00141648 |
| First Received | August 30, 2005 |
| Last Updated | September 29, 2009 |
| Last verified | September 2009 |
Tracking Information[ + expand ][ + ]
| First Received Date | August 30, 2005 |
|---|---|
| Last Updated Date | September 29, 2009 |
| Start Date | September 2000 |
| Estimated Primary Completion Date | February 2008 |
| Current 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] |
| Current Secondary Outcome Measures |
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Descriptive Information[ + expand ][ + ]
| Brief Title | Chemotherapy and Radiotherapy for Osteolymphoma |
|---|---|
| Official Title | A Prospective Non-randomised Trial of Chemotherapy and Radiotherapy for Osteolymphoma |
| 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. |
| Study Type | Interventional |
| Study Phase | N/A |
| Study Design | Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment |
| Condition | 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 Other Names: Endoxan, Caelyx, Vincristine sulfate injection, PredsoneRadiation: Radiotherapy Total 45 Gy in 25 fractions Other Names: Radiation |
| Study Arm (s) | Experimental: 1 Chemotherapy followed by radiotherapy to begin 3 weeks after the last cycle. |
Recruitment Information[ + expand ][ + ]
| Recruitment Status | Completed |
|---|---|
| Estimated Enrollment | 70 |
| Estimated Completion Date | February 2008 |
| Estimated Primary Completion Date | February 2007 |
| 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 |
| Gender | Both |
| Ages | 17 Years |
| Accepts Healthy Volunteers | No |
| Contacts | Not Provided |
| Location Countries | Australia, New Zealand |
Administrative Information[ + expand ][ + ]
| NCT Number | NCT00141648 |
|---|---|
| Other Study ID Numbers | TROG 99.04 |
| Has Data Monitoring Committee | No |
| Information Provided By | Trans-Tasman Radiation Oncology Group (TROG) |
| Study Sponsor | Trans-Tasman Radiation Oncology Group (TROG) |
| Collaborators | Australasian Leukaemia and Lymphoma Group Australasian Radiation Oncology Lymphoma Group Wesley Research Institute |
| Investigators | Study Chair: David Christie, FRANZCR East Coasr Cancer Centre |
| Verification Date | September 2009 |
Locations[ + expand ][ + ]
| 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 |
| 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 |
| Royal Adelaide Hospital | Adelaide, South Australia, Australia, 5000 |
| Royal Hobart Hospital | Hobart, Tasmania, Australia, 7000 |
| Launceston General Hospital | Launceston, Tasmania, Australia, 7250 |
| Peter MacCallum Cancer Centre | East Melbourne, Victoria, Australia, 3002 |
| Andrew Love Cancer Care Centre, Geelong Hospital | Geelong, Victoria, Australia, 3220 |
| Sir Charles Gairdner Hospital | Nedlands, Western Australia, Australia, 6009 |
| Auckland Hospital | Auckland, New Zealand, 1001 |
| Waikato Hospital | Hamilton, New Zealand, 3200 |
| Palmerston North Hospital | Palmerston North, New Zealand |