Clinical trial · Interventional
GELAD Chemotherapy and Sandwiched Radiotherapy in the Treatment of Stage IE/IIE Natural Killer/T-cell Lymphoma
The Efficacy and Safety of Gemcitabine, Etoposide, Dexamethasone and Pegaspargase Chemotherapy (GELAD) With Sandwiched Radiotherapy in the Treatment of Stage IE/II Natural Killer/T-Cell Lymphoma: A Multicenter, Prospective Study
NCT02733458CI-TRIAL-00053876completedN/AClinicalTrials.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 evaluate the efficacy and safety of gemcitabine, etoposide, pegaspargase and dexamethasone (GELAD) chemotherapy and sandwiched radiotherapy as first-line treatment in patients with de novo stage IE/IIE extranodal natural killer/T-cell lymphoma, nasal type.
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 |
|---|---|---|---|
| GELAD | Drug | — | UNRESOLVED |
| Radiotherapy | Radiation | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- GELAD/Radiation
- description
- Patients will be initially treated with two cycles GELAD chemotherapy, followed by 50-56Gy radiotherapy, and completed with another two cycles GELAD chemotherapy. GELAD chemotherapy will be repeated every 21 days. Radiotherapy will be delivered in 25-32 fractions.
- interventionNames
- Drug: GELAD
- Radiation: Radiotherapy
Primary outcomes (1)
- measure
- Complete response rate
- timeFrame
- 28 days after 4 cycles of chemotherapy
- description
- The complete response rate will be assessed on day 28 after the 4th course of chemotherapy.
Secondary outcomes (4)
- measure
- Progression free survival
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 15 Years
- Maximum age
- 75 Years
Show eligibility criteria text
Inclusion Criteria: * Pathological diagnosis of extranodal natural killer/T-cell lymphoma, nasal type, previously untreated * Eastern Cooperative Oncology Group (ECOG ) performance status 0\~3 * Stage IE to IIE disease with at least one measurable lesion in the nasal cavity, paranasal sinuses, orbit, pharynx, Waldeyer's ring, or oral cavity. * Preserved organ functions for: absolute neutrophil counter (ANC)\>1.0×109/L, Platelet\>50×109/L, hemoglobin\>80g/L, total bilirubin (TBIL)\<2×ULN, alanine transaminase (ALT)\<2×ULN, serum creatinine\<1.5×ULN，fibrinogen≥1.0g/L, LVEF≥50% * No history of chemotherapy or radiotherapy. * Signed Informed consented Exclusion Criteria: * Concurrent cancers need surgery or chemotherapy within 6 months. * Significant complications: LVEF≤50%, coagulopathy, autoimmune disease, severe infection, or liver cirrhosis, hemophagocytic lymphohistiocytosis. * Mental disorders. * Pregnant or lactation * HIV, hepatitis virus C (HCV), or active hepatitis virus B (HBV) infection with HBV DNA≥105 copies/ml. * History of pancreatitis * Known history for grade 3/4 allergy to the drugs in chemotherapy regimen. * Enrolled in other trial treatment
References
Publications (1)
- DERIVEDZhu Y, Tian S, Xu L, Ma Y, Zhang W, Wang L, Jin L, Liu C, Zhu C, Li Z, Hao S, Zhong H, Ding H, Tao R. GELAD chemotherapy with sandwiched radiotherapy for patients with newly diagnosed stage IE/IIE natural killer/T-cell lymphoma: a prospective multicentre study. Br J Haematol. 2022 Feb;196(4):939-946. doi: 10.1111/bjh.17960. Epub 2021 Nov 21. PMID 34806163