Ignite Creation Date:
2024-05-05 @ 11:42 AM
Last Modification Date:
2024-10-26 @ 9:12 AM
Study NCT ID:
NCT00115700
Status:
COMPLETED
Last Update Posted:
2022-11-18
First Post:
2005-06-23
Brief Title:
Radiotherapy Versus Radiotherapy Plus Chemotherapy in Early Stage Follicular Lymphoma
Sponsor:
Trans Tasman Radiation Oncology Group
Organization:
Trans Tasman Radiation Oncology Group
Study Overview
Official Title:
A Randomised Multicentre Trial of Involved Field Radiotherapy Versus Involved Field Radiotherapy Plus Chemotherapy in Combination With Rituximab Mabthera for Stage I - II Low Grade Follicular Lymphoma
Status:
COMPLETED
Status Verified Date:
2022-11
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Patients with stage I and II low grade follicular lymphoma are randomised between standard therapy involved field radiotherapy and investigational therapy involved field radiotherapy and chemotherapy plus rituximab The main endpoint is progression free survival but overall survival and the influence of t1418 status will also be studied
Detailed Description:
Radiotherapy is the only modality which has been proven to have curative potential in patients with localised low grade lymphoma Despite excellent control of the local tumour most patients relapse outside the area treated with radiation and most of these ultimately die from lymphoma This study tests the hypothesis that the addition of six cycles of chemotherapy plus rituximab systemic chemotherapy can eradicate undetectable lymphoma deposits outside the radiation field and thereby improve the cure rate The study will specifically test the hypothesis that six cycles of adjuvant CVP chemotherapy cyclophosphamide vincristine prednisolone in combination with Rituximab will improve progression-free survival for patients with stage I and II low-grade follicular lymphoma treated with involved-field radiotherapy IFRT That is will patients given radiotherapy plus systemic chemotherapy live longer or remain free from disease longer than patients treated with radiation alone Radiotherapy alone is widely regarded as the standard treatment for this disease
There are a number of secondary endpoints to the study as follows
1 Comparison the pre- and post-treatment prevalence of the t1418 translocation in peripheral blood and bone marrow of patients treated with either IFRT alone or IFRT plus chemotherapy This translocation is potentially a marker for minimal residual disease and eradication of the marker from blood cells may have prognostic implications The clinical value of molecular remission as an early predictor of freedom from progression FFP and survival will be assessed
2 Comparison of overall survival and FFP for patients treated with IFRT alone with overall survival and FFP for patients treated with combined IFRT and systemic therapy Delay of progression of disease may be of limited value if overall survival is the same
3 Comparison of acute and late toxicity and second malignancy rates for patients treated with IFRT or IFRT plus systemic therapy
4 Delineation of the location of first relapse in relation to radiation therapy fields
There are a number of secondary endpoints to the study as follows
1 Comparison the pre- and post-treatment prevalence of the t1418 translocation in peripheral blood and bone marrow of patients treated with either IFRT alone or IFRT plus chemotherapy This translocation is potentially a marker for minimal residual disease and eradication of the marker from blood cells may have prognostic implications The clinical value of molecular remission as an early predictor of freedom from progression FFP and survival will be assessed
2 Comparison of overall survival and FFP for patients treated with IFRT alone with overall survival and FFP for patients treated with combined IFRT and systemic therapy Delay of progression of disease may be of limited value if overall survival is the same
3 Comparison of acute and late toxicity and second malignancy rates for patients treated with IFRT or IFRT plus systemic therapy
4 Delineation of the location of first relapse in relation to radiation therapy fields
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| ALLG NHLLOW5 | OTHER | Collaborative group | None |