Status:
UNKNOWN
Involved Field Radiotherapy for Non-gastric Marginal Zone Lymphoma
Lead Sponsor:
Trans Tasman Radiation Oncology Group
Collaborating Sponsors:
Australasian Leukaemia and Lymphoma Group
Peter MacCallum Cancer Centre, Australia
Conditions:
Non-gastric Marginal Zone Lymphoma
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
This prospective study will test the following hypotheses in patients with stage I-II low grade marginal zone (MZ) lymphoma: * Involved Field Radiotherapy will produce a complete response rate of \> ...
Detailed Description
Aims of the study : * To conduct the first multicentre prospective trial of radiotherapy (RT) in stage I-II Marginal Zone Lymphoma (MZL) * To prospectively identify causal factors for MZL, including ...
Eligibility Criteria
Inclusion
- Patients of at least 18 years old with histologically documented non-gastric marginal zone lymphoma.
- Disease limited to stages I and II after adequate staging (see Appendix II), patients with stage IV with extranodal disease confined to paired organs (e.g. salivary glands) and including any local extension of this disease into adjacent tissues. Patients with involved lymph nodes on the same side of the diaphragm in addition to paired organ involvement are also eligible, provided all involved tumour sites, nodal and extranodal, can be irradiated to 30 Gy within the tolerance of the relevant normal tissues. If paired organ involvement was regarded as a single extranodal site (rather than 2 separate sites and hence stage IV), eligible patients would then be regarded as having stage IE or IIE disease. Patients with wider dissemination (bone marrow, liver etc) are ineligible.
- Anticipated life expectancy \> 2 years
- Given written informed consent
- Been assessed by a radiation oncologist
- Agree to undergo breath testing for H. pylori and/or oesophagogastroduodenoscopy to exclude active infection with helicobacter pylori
- Must be available for long-term follow up
Exclusion
- Splenic marginal zone lymphoma
- Received previous locoregional radiotherapy
- A medical contraindication to radiotherapy
- Any previous or concurrent malignancy other than curatively treated non-melanoma skin cancer, level 1 malignant melanoma, or in situ cervical cancer, unless disease and treatment-free for 5 years
- Such extensive involvement of the thorax that treatment with radiotherapy alone would be hazardous because of excessive lung irradiation, even if a shrinking field technique were employed
- Suspected or confirmed pregnancy
- Transformation to large cell lymphoma or other aggressive histology
- Disease that is widely disseminated (bone marrow, liver etc)
Key Trial Info
Start Date :
July 8 2007
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 1 2019
Estimated Enrollment :
79 Patients enrolled
Trial Details
Trial ID
NCT00377195
Start Date
July 8 2007
End Date
April 1 2019
Last Update
February 28 2018
Active Locations (5)
Enter a location and click search to find clinical trials sorted by distance.
1
Royal Prince Alfred Hospital
Camperdown, New South Wales, Australia
2
Calvary Mater Newcastle
Newcastle, New South Wales, Australia
3
Royal Brisbane and Women's Hospital
Brisbane, Queensland, Australia
4
Royal Adelaide Hospital
Adelaide, South Australia, Australia