Clinical trial · Interventional
A Phase II Trial of Intermediate Radiation Dose For Lymphoma
A Phase II Trial of Intermediate Radiation Dose For 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)
The purpose of this study is to determine the optimal radiation dose fractionation regimen for low grade follicular lymphoma. It is hypothesized that the complete response rate with the use of 12 Gy in 6 daily fractions is 80% (10% total width of the confidence interval) at 3 months. This phase II study will evaluate whether an intermediate dose for follicular lymphoma is associated with excellent response rates while minimizing acute and late toxicity.
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 (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| 12 Gy in 6 daily fractions | Radiation | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- 12 Gy in 6 daily fractions
- interventionNames
- Radiation: 12 Gy in 6 daily fractions
Primary outcomes (1)
- measure
- Complete response within the radiated volume at 1month post radiation
- timeFrame
- 1 month
- description
- Participants will be assessed for response at 1 month (primary outcome) and then 3 months following completion of radiotherapy, clinically or radiographically, as appropriate. Complete response is defined as absence of detectable disease in the radiated volume. Partial response is 50% or more reduction in the volume of disease in the radiated volume. Overall response is defined as complete and partial response. Stable disease is defined as no change in the irradiated tumour or less than 50% reduction. Progressive disease is defined as enlargement of the irradiated tumour
Secondary outcomes (1)
- measure
- Overall survival, progression-free survival and toxicity
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * ≥ 18 years or older * Pathology review at Sunnybrook Health Sciences Centre showing low grade (grade 1- 2) follicular lymphoma * Previously un-irradiated stages I-IV low grade follicular lymphoma * Radiation indicated for local disease control (radical or palliative) * Able to give informed consent * Non-bulky targets (less than 7cm) Exclusion Criteria: * Systemic therapy (including steroids) for lymphoma within 3 months before or after radiotherapy * Prognosis less than 3 months * Pregnancy
References
Publications (0)
Data not yet available