Involved Field Radiotherapy for Non-gastric Marginal Zone Lymphoma (NCT00377195) | Clinical Trial Compass
UnknownPhase 2
Involved Field Radiotherapy for Non-gastric Marginal Zone Lymphoma
Australia79 participantsStarted 2007-07-08
Plain-language 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 \> 90%
* Radiotherapy will be associated with a locoregional progression of \< 20% after 10 years
* Death from MZ lymphoma will occur in \< 40% of patients within 10 years of radiotherapy
This study secondary objectives are:
* To collect information on the prevalence of H. pylori in non-gastric MALT lymphoma
* To estimate rates of acute and late toxicity of radiotherapy
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* 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 Criteria:
* 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 cance…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Freedom from locoregional progression (FFLRP) rate
Timeframe: There will be an interim analysis at the end of accual (approx 5 years), at 5 years from the end of accrual and a final analysis at 10 years form the end of accrual.
2
Complete response rate
Timeframe: A final analysis at 10 years form the end of accrual.
3
Cancer-specific survival
Timeframe: A final analysis at 10 years form the end of accrual.