Clinical trial · Interventional
30Gy Versus 40Gy Involved-field Radiotherapy for Localized Diffuse Large B Cell Lymphoma Achieving CR After Chemotherapy
Phase 3 Study of 30Gy Versus 40Gy Involved-field Radiotherapy in Localized Diffuse Large B Cell Lymphoma Achieving CR After Chemotherapy
NCT01156259CI-TRIAL-00003632unknownPhase 3ClinicalTrials.gov clinicaltrialsProvenance
- 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 whether 30Gy Involved-field Radiotherapy (IFRT) is as effective as 40Gy in the treatment of localized Diffused Large B cell Lymphoma (DLBCL) when completing CR after chemotherapy.
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 |
|---|---|---|---|
| Lymphoma, Large B-Cell, Diffuse | Lymphoma | ONTOLOGY_EXACT | 0.85 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| 3D-CRT based Involved Field Radiotherapy | Radiation | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- 30 Gy
- interventionNames
- Radiation: 3D-CRT based Involved Field Radiotherapy
- type
- ACTIVE_COMPARATOR
- label
- 40 Gy
- interventionNames
- Radiation: 3D-CRT based Involved Field Radiotherapy
Primary outcomes (1)
- measure
- disease free survival
- timeFrame
- five years
Secondary outcomes (4)
- measure
- overall survival
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 15 Years
Show eligibility criteria text
Inclusion Criteria: * biopsy-proved Diffuse Large B cell lymphoma * nonbulky stage I, nonbulky stage IE, nonbulky stage II, or nonbulky stage IIE disease(Bulky disease was defined as a mass 10 cm or more in maximal diameter) according to Ann Arbor Staging * provide written informed consent * Complete regression after chemotherapy * Considerable to CT simulation and 3D CRT or IMRT * Performance status 0-2 WHO criteria；life expectation\>6 months * negative for human immunodeficiency virus syndrome (HIV) * Minimal staging included chest radiograph, computed tomography of the abdomen and pelvis, and single percutaneous bone marrow biopsy and blood studies Exclusion Criteria: * primary mediastinal large B cell lymphoma * dermatological lymphoma * testicular lymphoma * primary central nerve system lymphoma * prior RT * history of low-grade lymphoma congestive * history of heart failure (CHF; New York Heart Association \[NYHA\] classifications III-IV), history of neoplasm (adequately treated basal cell carcinoma of the skin or in situ carcinoma of the uterine cervix were allowed), abnormal liver function tests (aminotransferases and alkaline phosphatase \> 2.5 times the upper limit of normal, bilirubin \> 50 ), renal insufficiency (serum creatinine \> 300 ), and patients with any serious medical or psychiatric illness that would prevent informed consent or completion of protocol-prescribed treatment and follow-up
References
Publications (0)
Data not yet available
No reference posted for this study.