Chemotherapy and Radiotherapy for Osteolymphoma

Sponsor

Trans Tasman Radiation Oncology Group (Other)

Overall Status

Completed

CT.gov ID

NCT00141648

Collaborator

Australasian Leukaemia and Lymphoma Group (Other), Australasian Radiation Oncology Lymphoma Group (Other), Wesley Research Institute (Other)

Enrollment

Locations

Arm

Duration (Months)

3.5

Patients Per Site

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Osteolymphoma	Drug: Cyclophosphamide, Doxorubicin, Vincristine, Prednisolone. Radiation: Radiotherapy	N/A

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

Study Type:

Interventional

Actual Enrollment :

70 participants

Allocation:

Non-Randomized

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

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

Study Start Date :

Sep 1, 2000

Actual Primary Completion Date :

Feb 1, 2007

Actual Study Completion Date :

Feb 1, 2008

Arms and Interventions

Arm	Intervention/Treatment
Experimental: 1 Chemotherapy followed by radiotherapy to begin 3 weeks after the last cycle.	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, Predsone Radiation: Radiotherapy Total 45 Gy in 25 fractions Other Names: Radiation

Arm

Intervention/Treatment

Experimental: 1

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

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, Predsone

Radiation: Radiotherapy

Total 45 Gy in 25 fractions

Other Names:

Radiation

Outcome Measures

Primary Outcome Measures

Overall Survival. The time from registration to the date of death [Main analysis when accrual is complete at approx. 10 years.]

Secondary Outcome Measures

Time to local or regional failure. Measured from registration. [Main analysis when accrual is complete at approx. 10 years.]
Pathological fracture rate. Measured from registration. [Main analysis when accrual is complete at approx. 10 years.]

Eligibility Criteria

Criteria

Ages Eligible for Study:

17 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Royal Prince Alfred Hospital	Camperdown	New South Wales	Australia	2050
2	Liverpool Hospital	Liverpool	New South Wales	Australia	1871
3	Calvary Mater Newcastle	Newcastle	New South Wales	Australia	2310
4	Westmead Hospital	Wentworthville	New South Wales	Australia	2145
5	Wollongong Hospital	Wollongong	New South Wales	Australia
6	The Wesley Radiation Oncology Pty Ltd	Auchenflower	Queensland	Australia	4006
7	Royal Brisbane Hospital	Herston	Queensland	Australia	4029
8	Mater QRI	South Brisbane	Queensland	Australia	4101
9	North Queensland Oncology Service	Townsville	Queensland	Australia	4810
10	East Coast Cancer Centre, John Flynn Hospital	Tugun	Queensland	Australia	4224
11	Princess Alexandra Hospital	Woolloongabba	Queensland	Australia	4102
12	Royal Adelaide Hospital	Adelaide	South Australia	Australia	5000
13	Royal Hobart Hospital	Hobart	Tasmania	Australia	7000
14	Launceston General Hospital	Launceston	Tasmania	Australia	7250
15	Peter MacCallum Cancer Centre	East Melbourne	Victoria	Australia	3002
16	Andrew Love Cancer Care Centre, Geelong Hospital	Geelong	Victoria	Australia	3220
17	Sir Charles Gairdner Hospital	Nedlands	Western Australia	Australia	6009
18	Auckland Hospital	Auckland		New Zealand	1001
19	Waikato Hospital	Hamilton		New Zealand	3200
20	Palmerston North Hospital	Palmerston North		New Zealand