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

• Status: Not yet recruiting
• Trial end date: 2028-12-31
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: N/A
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Sun Yat-sen University
• Collaborators: Affiliated Cancer Hospital & Institute of Guangzhou Medical University; Fifth Affiliated Hospital, Sun Yat-Sen University; First People's Hospital of Foshan; Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University

Criteria

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.