Involved Field Radiotherapy for Non-Gastric Marginal Zone Lymphoma

Phase 2

Active, not recruiting

• Conditions: on-Gastric Marginal Zone Lymphoma; Non-Gastric Marginal Zone Lymphoma; Cancer - Lymphoma (non Hodgkin's lymphoma) - Low grade lymphoma

• Registration Number: ACTRN12607000164493
• Lead Sponsor: Trans Tasman Radiation Oncology Group (TROG)

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2007-03-12
• Last Update Posted: 13 January 2020

Recruitment & Eligibility

• Status: Active, not recruiting
• Sex: All
• Target Recruitment: 100

Inclusion Criteria

1. Patients of at least 18 years of age with histologically documented non-gastric marginal zone lymphoma. 2. Disease limited to stages I and II after adequate staging, 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 30Gy within tolerance of the relevent normal tissues. If paired organ involvement was regarded as a single extranodal site (rather than 2 seperate sites and hencs 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. 3. Anticipated life expectancy > 2 years 4. Given written informed consent 5. Been assessed by a radiation oncologist 6. Agree to undergo breath testing for H. pylori and/or oesophagogastroduodenoscopy to exclude active infection with helicobacter pylori 7. Must be available for long-term follow up.

Exclusion Criteria

1. Splenic marginal zone lymphoma 2. Received previous locoregional radiotherapy 3. A medical contraindication to radiotherapy 4. 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. 5. 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 6. Suspected or confirmed pregnancy. 7. Transformation to large cell lymphoma or other aggressive histology. 8. Disease that is widely disseminated (bone marrow, liver etc)

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Freedom from locoregional progression (FFLRP) rate - will be estimated as the cumulative incidence of locoregional progression as obtained as part of a competing risks analysis in which the competing events are distant progression and death without prior progression.[Six to eight weeks after completion of radiotherapy, all patients require interim follow up. After the first follow-up, regular follow-up visits will then occur as follows: 3-monthly intervals for 2 years following restaging; then 6-monthly until 5 years. The analysis of this outcome will be done at 5 years. ];Complete response rate - Disappearance of all clinical and radiological evidence of tumour. [Six to eight weeks after completion of radiotherapy, all patients require interim follow up. After the first follow-up, regular follow-up visits will then occur as follows: 3-monthly intervals for 2 years following restaging; then 6-monthly until 5 years. The analysis of this outcome will be done at 5 years.]