Involved Field Radiotherapy for Non-Gastric Marginal Zone Lymphoma

Trans Tasman Radiation Oncology Group (TROG) 05.02 - A Prospective Single Arm Trial of Involved Field Radiotherapy Alone for Stage I-II Low Grade Non-Gastric Marginal Zone Lymphoma to improve response rates.

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

ANZCTR

Registry ID

ACTRN12607000164493

Acronym

TROG 05.02

Enrollment

Registered

2007-03-12

Start date

2007-06-08

Completion date

2014-10-30

Last updated

2026-02-04

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Brief summary

This prospective study will test the following hypotheses in patients with stage I-II low grade marginal zone (MZ) lymphoma: 1. Involved Field Radiotherapy will produce a complete response rate of > 90% 2. Radiotherapy will be associated with a locoregional progression of < 20% after 10 years 3. Death from MZ lymphoma will occur in < 40% of patients within 10 years of radiotherapy This study secondary objectives are: 1. To collect information on the prevalence of H. pylori in non-gastric MALT lymphoma 2. To estimate rates of acute and late toxicity of radiotherapy

Interventions

All patients receive a Helicobacter Pylori (H.Pylori) Breath test. If this is positive, they undergo H.Pylori eradication. Then all pateints receive Radiotherapy 24-30Gy. Daily fractions of 1.5 -2.0 Gy, 5 days per week with a duration of 4 weeks.

Study design

Allocation

Non-randomised trial

Intervention model

Single group

Primary purpose

Treatment

Masking

Open (masking not used)

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Healthy volunteers

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)

Outcome results