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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
Condition(s) studied
Nasopharyngeal Carcinoma
Investigational drug(s) / intervention(s)
Induction chemotherapy plus Concurrent chemotherapyConcurrent chemotherapyIMRT
Induction chemotherapy plus Concurrent chemotherapy: Induction chemotherapy: TP( Docetaxel 75mg/m2, D1 and cisplatin 25 mg/m2, D1-3 every 3 weeks for 3 cycles) OR GP (Gemcitabine 1000mg/m2，D1,D8 and cisplatin 25 mg/m2, D1-3 every 3 weeks for 3 cycles）
Concurrent chemotherapy: DDP -- Cisplatin 25 mg/m2, D1-3 , every 3 weeks for 2 cycles during radiation.
Concurrent chemotherapy: Concurrent chemotherapy: DDP -- Cisplatin 25 mg/m2, D1-3 , every 3 weeks for 2 cycles during radiation.
IMRT: Radical radiation: Intensity-modulated radiotherapy
Study 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.
Eligibility
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.
Primary outcome measure(s)
- Failure Free Survival — Two years
The absence of relapse, non-relapse mortality or addition of another systemic therapythe last follow-up if there is no disease progression.
Trial sites (1)
| Facility | City | Region | Status |
|---|
| Sun Yat-sen University Cancer Center |
Guangzhou |
Guangdong |
|