Clinical trial · Interventional
Radiotherapy Versus Radiotherapy Plus Chemotherapy in Early Stage Follicular Lymphoma
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
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Follicular Lymphoma | Follicular Lymphoma | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (5)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Cyclophosphamide | Drug | Cyclophosphamide | ALIAS |
| Prednisolone | Drug | Prednisolone | ALIAS |
| Radiotherapy | Radiation | — | UNRESOLVED |
| Rituximab | Drug | Rituximab | ALIAS |
| Vincristine | Drug | Vincristine | ALIAS |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Radiotherapy+ Chemotherapy
- description
- Involved field Radiotherapy (RT) 30-36 GY plus Cyclophosphamide, Vincristine and Prednisolone (CVP) + rituximab × 6 cycles
- interventionNames
- Drug: Cyclophosphamide
- Radiation: Radiotherapy
- Drug: Vincristine
- Drug: Prednisolone
- Drug: Rituximab
- type
- ACTIVE_COMPARATOR
- label
- Radiotherapy alone
- description
- Involved field Radiotherapy (30-36 GY) alone
- interventionNames
- Radiation: Radiotherapy
Primary outcomes (1)
- measure
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Adult patients (≥ 18 years old) with histologically documented "follicular lymphoma, grade 1", grade 2", or "follicular lymphoma, grade 3a" diagnosed following an excisional, incisional or generous core biopsy. (i.e. an FNA alone is insufficient.) * Disease limited to stages I and II after adequate staging * Anticipated life expectancy \> 5 years * Given written informed consent * Been assessed by a radiation oncologist and a medical oncologist/ haematologist * WCC \> 3.0 x 10\^9/L, platelet count \> 100 x 10\^9/L, serum creatinine \< 0.15 mmol/L * Ability to commence radiotherapy within 6 weeks of randomisation * Women using effective contraception, are not pregnant and agree not to become pregnant during participating in the trial and during the 12 months thereafter. Men agree not to father a child during participation in the trial and during the 12 months thereafter. Exclusion Criteria: * Received previous systemic cytotoxic chemotherapy. * Received previous radiotherapy, (except superficial radiation therapy for non-melanoma skin cancers). * Received previous immunotherapy. * A medical contraindication to radiotherapy, chemotherapy, or rituximab. * 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 radiation therapy alone would be hazardous because of excessive lung irradiation, even if a shrinking field technique were employed. * Suspected or confirmed pregnancy. Must not be lactating. * Patients who have known human immuno-deficiency virus (HIV) infection or active hepatitis B (HBV). * Treatment within a clinical study within 30 days prior to study entry.
References
Publications (2)
- DERIVEDJohnstone 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. PMID 41580147
- DERIVEDMacManus 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. PMID 29975623