Clinical trial · Interventional
A Multicenter Randomized Controlled Clinical Study on the Treatment of T3N1M0 High Risk Nasopharyngeal Carcinoma With or Without Induction Chemotherapy Before Concurrent Radiotherapy and Chemotherapy
- 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 goal of this clinical trial is to compare the efficacy and safety of curative radiotherapy with or without induction chemotherapy in patients with T3N1M0 nasopharyngeal carcinoma. The main question\[s\] it aims to answer are: * Whether induction chemotherapy confers a survival benefit in patients with T3N1M0 nasopharyngeal carcinoma with high risks factors. * Whether induction chemotherapy worsens adverse effects in patients with T3N1M0 nasopharyngeal carcinoma. Participants in experimental group will receive 3 cycles induction chemotherapy (GP or TPF) followed by concurrent chemoradiotherapy.Participants in control group will receive concurrent chemoradiotherapy only. Researchers will compare FFS, OS and AE or SAE to see if patients can benefit from induction chemotherapy or screen out high-risk factors associated with survival benefits.
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 |
|---|---|---|---|
| Nasopharyngeal Carcinoma | Nasopharyngeal Carcinoma | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Concurrent chemotherapy | Drug | — | UNRESOLVED |
| IMRT | Radiation | — | UNRESOLVED |
| Induction chemotherapy plus Concurrent chemotherapy | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- IC plus CC plus IMRT
- description
- Induction chemotherapy followed by Intensity-modulated radiotherapy plus concurrent chemotherapy
- interventionNames
- Drug: Induction chemotherapy plus Concurrent chemotherapy
- Radiation: IMRT
- type
- ACTIVE_COMPARATOR
- label
- CC plus IMRT
- description
- Intensity-modulated radiotherapy plus concurrent chemotherapy alone
- interventionNames
- Drug: Concurrent chemotherapy
- Radiation: IMRT
Primary outcomes (1)
- measure
- Failure Free Survival
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 70 Years
Show eligibility criteria text
Inclusion Criteria: 1.Pathologically diagnosed with stage T3N1M0 nasopharyngeal cancer according to 2017 AJCC Cancer Staging Manual-8th Edition; not received anticancer treatment. 2.18-70 years old. 3. One or more of the following prognostic factors exist: 1. MRI showed extravasation of lymph node capsule, 2. MRI showed lymph node necrosis, 3. The maximum diameter of positive lymph nodes in the three-dimensional direction on MRI is ≥ 3cm, 4. 2 or more positive lymph nodes, 5. Peripheral blood EBV-DNA ≥ 4000 copies/ml, 6. The maximum SUV value of lymph nodes on PET/CT ≥ 9.3. 4.ECOG Score (PS score) 0 or 1. 5.Neutrophil count \> 1.5\*10\^9/L, hemoglobin \> 90g/L, and platelet count \> 100\*10\^9/L. 6.ALT or AST level \< 2.5 times upper normal limit (upper limit of normal, ULN), bilirubin level \< 1.5 times ULN. 7.Creatinine clearance level \> 60 ml/min. (Calculated according to Cockcroft Gault formula). 8.Patients must sign an informed consent and must be willing and able to comply with the visit, treatment protocol, laboratory tests and other requirements specified in the study protocol. Exclusion Criteria: 1. Patients who have other malignant tumors within 5 years, excluding carcinoma in situ, well treated non melanoma skin cancer and papillary thyroid cancer. 2. Other conditions that may affect the safety or test compliance of the subject as judged by the investigator, including symptomatic heart failure, unstable angina, myocardial infarction, active infection requiring systemic treatment, mental illness or family and social factors.
References
Publications (0)
Data not yet available