Involved Field Radiotherapy for Non-gastric Marginal Zone Lymphoma

NCT00377195 | Unknown Phase 2

• 1 other identifier: TROG 05.02
• Study Type: interventional
• Target: 79
• Locations: 1 country
• Sites: 5

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 \> 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

Conditions

Non-gastric Marginal Zone Lymphoma

Keywords

Marginal Zone Lymphoma; Involved field radiotherapy; H. pylori

Outcome Measures

Primary Outcomes (3)

• Freedom from locoregional progression (FFLRP) rate

  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.

• Complete response rate

  A final analysis at 10 years form the end of accrual.

• Cancer-specific survival

  A final analysis at 10 years form the end of accrual.

Secondary Outcomes (4)

• Overall survival

  A final analysis at 10 years form the end of accrual.

• Progression free survival

  A final analysis at 10 years form the end of accrual.

• Freedom from progression

  A final analysis at 10 years form the end of accrual.

• Acute and Late Toxicity rates

  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.

Study Arms (1)

1

EXPERIMENTAL

Radiation: Involved Field Radiotherapy

Interventions

Involved Field Radiotherapy RADIATION

The prescribed dose will be 30 Gy in 15-20 fractions, unless the orbit is to be treated, in which case the dose will be 24 Gy in 1.5 to 2 Gy fractions. Daily fractions of 1.5-2.0 Gy will be employed. Treatment will be given 5 days per week with the planned duration of treatment not exceeding 28 days.

Also known as: Radiation

1

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Trans Tasman Radiation Oncology Group: lead
• Australasian Leukaemia and Lymphoma Group: collaborator
• Peter MacCallum Cancer Centre, Australia: collaborator

Study Sites (5)

Royal Prince Alfred Hospital

Camperdown, New South Wales, Australia

Location

Calvary Mater Newcastle

Newcastle, New South Wales, Australia

Location

Royal Brisbane and Women's Hospital

Brisbane, Queensland, Australia

Location

Royal Adelaide Hospital

Adelaide, South Australia, Australia

Location

Peter MacCallum Cancer Centre

Melbourne, Victoria, 3000, Australia

Location

Related Links

• Click here for more information about this study on the TROG official website

MeSH Terms

Conditions

Lymphoma, B-Cell, Marginal Zone

Interventions

Radiation

Condition Hierarchy (Ancestors)

Lymphoma, B-Cell; Lymphoma, Non-Hodgkin; Lymphoma; Neoplasms by Histologic Type; Neoplasms; Lymphoproliferative Disorders; Lymphatic Diseases; Hemic and Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases

Intervention Hierarchy (Ancestors)

Physical Phenomena

Study Officials

• Michael MacManus

  Peter MacCallum Cancer Centre, Australia

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 14, 2006
• First Posted: September 18, 2006
• Study Start: July 8, 2007
• Primary Completion: April 24, 2017
• Study Completion: April 1, 2019
• Last Updated: February 28, 2018

Record last verified: 2018-02

Locations

AU (5)