Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 2:03 PM
Ignite Modification Date:
2025-12-24 @ 2:03 PM
NCT ID:
NCT00377195
Eligibility Criteria:
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 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)
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT00377195
Study Brief:
Protocol Section:
NCT00377195