Clinical trial · Interventional
Radiotherapy Alone Versus Concurrent Chemoradiation in Low Risk NK/T-cell Lymphoma
A Randomized Phase II Study of Comparing Radiotherapy Alone With Concurrent Chemoradiation in Patients With Low Risk NK/T-cell Lymphoma
NCT01667289CI-TRIAL-00009648terminatedPhase 2ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): unexpected high grade of mucositis observed
Summary
Brief summary (as posted)
The purpose of this study is to prove the superiority of concurrent chemoradiation compared with radiotherapy alone in patients with low risk NK/T-cell lymphoma.
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 |
|---|---|---|---|
| Extranodal NK/T-cell Lymphoma, Nasal Type | Extranodal NK-/T-Cell Lymphoma, Nasal Type | ONTOLOGY_EXACT | 0.90 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Concurrent chemoradiation | Drug | — | UNRESOLVED |
| Radiotherapy alone | Radiation | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- ACTIVE_COMPARATOR
- label
- Radiotherapy alone
- description
- Radiotherapy alone Technique: IMRT Total Dose: 50 Gy Per fraction: 2 Gy
- interventionNames
- Radiation: Radiotherapy alone
- type
- EXPERIMENTAL
- label
- Concurrent chemoradiation
- description
- Concurrent chemoradiation Chemotherapy: Methotrexate 40 mg/m2 weekly X 5 Radiotherapy Technique: IMRT Total dose: 50 Gy Per Fraction: 2 Gy
- interventionNames
- Radiation: Radiotherapy alone
- Drug: Concurrent chemoradiation
Primary outcomes (1)
- measure
- 3-year Progression-free survival
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 75 Years
Show eligibility criteria text
Inclusion Criteria: * Age range 18-75 years old * Histological confirmed, previously untreated stage IE nasal NK/T cell lymphoma without following risk factors including local invasion, B symptoms and high LDH level * ECOG performance status 0-1 * Life expectancy of more than 3 months * Adequate bone marrow and organ functions Exclusion Criteria: * non-nasal NK/T-cell lymphoma * Prior exposure of methotrexate * With third space effusion * Pregnant or lactating women * Serious uncontrolled diseases and intercurrent infection * History of other malignancies except cured basal cell carcinoma of skin and carcinoma in-situ of uterine cervix
References
Publications (0)
Data not yet available
No reference posted for this study.