drugset / Trial / NCT00115700
Radiotherapy Versus Radiotherapy Plus Chemotherapy in Early Stage Follicular Lymphoma
Phase 3
Completed
150 enrolled
Trans Tasman Radiation Oncology Group
Australasian Leukaemia and Lymphoma Group · collab
RandomizedParallel-groupOpen-labelTreatment
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 t(14;18) status will also be studied.
Timeline
- Start
- 2000-02
- Primary completion
- 2018-08
- Completion
- 2018-08
Outcome
Met primary endpoint
paper PFS was superior in arm B (hazard ratio, 0.57; 95% CI, 0.34 to 0.95; P = .033). PMID 29975623 ↗
paper Systemic therapy with R-CVP after IFRT reduced relapse outside radiation fields and significantly improved PFS. PMID 29975623 ↗
Publications
- Johnstone P, Bressel M, Seymour JF, Juneja S, Ahmad H, MacManus M. Secondary outcomes of the TROG 99.03 randomized trial of systemic therapy after involved-field radiotherapy in early-stage follicular lymphoma, including toxicity, relapse and second malignancy data. Radiother Oncol. 2026 Apr;217:111388. doi: 10.1016/j.radonc.2026.111388. Epub 2026 Jan 22.
- MacManus M, Fisher R, Roos D, O'Brien P, Macann A, Davis S, Tsang R, Christie D, McClure B, Joseph D, Jayamohan J, Seymour JF. Randomized Trial of Systemic Therapy After Involved-Field Radiotherapy in Patients With Early-Stage Follicular Lymphoma: TROG 99.03. J Clin Oncol. 2018 Oct 10;36(29):2918-2925. doi: 10.1200/JCO.2018.77.9892. Epub 2018 Jul 5.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Cyclophosphamide | Other / unclassified | 1000 mg/m2 | Intravenous |
| Subject | Prednisolone | Other / unclassified | 50 mg/m2 | Oral |
| Subject | Rituximab | Monoclonal antibody | 375 mg/m2 | Intravenous |
| Subject | Vincristine | Small molecule | 1.4 mg/m2 | Intravenous |