Clinical trial · Interventional
IMRT Combined With Lobaplatin-based CCRT in Nasopharyngeal Carcinoma
Intensity-modulated Radiotherapy Combined With Lobaplatin-based Concurrent Chemotherapy in the Treatment of Elderly Patients With Nasopharyngeal Carcinoma
NCT06688175CI-TRIAL-00093262enrolling by invitationPhase 2ClinicalTrials.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)
This prospective, multicenter, single-arm, open-label phase II clinical study aimed to investigate the efficacy and safety of intensity-modulated radiotherapy combined with lobaplatin-based concurrent chemotherapy in the treatment of elderly patients with nasopharyngeal carcinoma
Conditions
Conditions (3)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Chemotherapy | — | UNRESOLVED | — |
| Elderly | — | UNRESOLVED | — |
| Nasopharyngeal Neoplasms | Nasopharyngeal Neoplasm | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| IMRT combined with lobaplatin-based concurrent chemotherapy | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Experimental
- description
- in the treatment of elderly patients with nasopharyngeal carcinoma
- interventionNames
- Drug: IMRT combined with lobaplatin-based concurrent chemotherapy
Primary outcomes (1)
- measure
- objective response rate (ORR)
- timeFrame
- 6 months
- description
- ORR encompasses both CR and PR.
Secondary outcomes (5)
- measure
- Safety
- timeFrame
- 3 months
- description
- Number of participants with treatment-related adverse events as assessed by CTCAE v4.0
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 65 Years
- Maximum age
- 80 Years
Show eligibility criteria text
Inclusion Criteria: * Pathologically confirmed differentiated non-keratinizing carcinoma and undifferentiated non-keratinizing carcinoma; * Stage II-IVa (UICC 8th edition); * Acceptable induction chemotherapy and Tarceva targeted therapy; * No history of other malignant tumors; * Male or female, aged 65-80 years. * Liver function: Total bilirubin ≤ Upper Limit of Normal (ULN); AST and ALT ≤ 2.5 times ULN; Alkaline phosphatase ≤ 5 times ULN; * Renal function: Creatinine clearance ≥ 60 ml/min or Creatinine ≤ 1.5 × ULN; * Hematological tests: Absolute Neutrophil Count (ANC) ≥ 2 × 10\^9/L, Platelet count ≥ 100 × 10\^9/L, and Hemoglobin ≥ 9 g/dL; * No severe dysfunction of vital organs such as heart and lung; * PS score ≤ 2 points Exclusion Criteria: * Distant metastases detected before treatment; * Refusal to sign the informed consent form; * Patients who cannot comply with regular follow-up due to psychological, social, family, or geographical reasons; * Simultaneously receiving other experimental treatments in clinical trials (during the treatment phase of clinical research); * Severe, uncontrolled infections or medical conditions; * Vital organ dysfunction, decompensated heart, lung, kidney, or liver failure, unable to tolerate radiotherapy and chemotherapy; * Laboratory tests: Total bilirubin \> Upper Limit of Normal (ULN); AST and/or ALT \> 1.5 times ULN with alkaline phosphatase \> 2.5 times ULN; * Factors affecting drug administration, distribution, metabolism, and excretion, such as mental abnormalities, central nervous system abnormalities, chronic diarrhea, ascites, pleural effusion, etc.; * Long-term use of immunosuppressants after organ transplantation; * Patients with a history of other malignant tumors before enrollment.
References
Publications (0)
Data not yet available
No reference posted for this study.