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
Overview
- Phase
- N/A
- Intervention
- Induction chemotherapy plus Concurrent chemotherapy
- Conditions
- Nasopharyngeal Carcinoma
- Sponsor
- Sun Yat-sen University
- Enrollment
- 236
- Locations
- 1
- Primary Endpoint
- Failure Free Survival
- Status
- Not Yet Recruiting
- Last Updated
- 3 years ago
Overview
Brief 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.
Detailed Description
In this study, 236 patients with pathologically diagnosed nasopharyngeal carcinoma and clinical stage of T3N1M0 will be randomly divided into two groups, 118 in the experimental group (induction chemotherapy + concurrent chemoradiotherapy) and 118 in the control group (concurrent chemoradiotherapy). The experimental group received 3 courses of induction chemotherapy followed by radical radiotherapy for the nasopharynx and neck, and 2-3 courses of cisplatin (100mg/m2, Q3W) treatment during radiotherapy. The control group received radical radiotherapy for the nasopharynx and neck, and 2-3 courses of cisplatin (100mg/m2, Q3W) during radiotherapy. Since there have been clinical trials to prove that GP or TPF induction chemotherapy is effective in locally advanced nasopharyngeal carcinoma, the induction chemotherapy regimen in this study can be selected by the investigator with GP or TPF. During treatment and within 3 years after treatment, the efficacy and safety of patients in both groups were followed up and evaluated.
Investigators
Fang-Yun Xie
Sun Yat-sen University Cancer Center
Sun Yat-sen University
Eligibility 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.
- •One or more of the following prognostic factors exist:
- •MRI showed extravasation of lymph node capsule,
- •MRI showed lymph node necrosis,
- •The maximum diameter of positive lymph nodes in the three-dimensional direction on MRI is ≥ 3cm,
- •2 or more positive lymph nodes,
- •Peripheral blood EBV-DNA ≥ 4000 copies/ml,
- •The maximum SUV value of lymph nodes on PET/CT ≥ 9.
- •4.ECOG Score (PS score) 0 or
Exclusion Criteria
- •Patients who have other malignant tumors within 5 years, excluding carcinoma in situ, well treated non melanoma skin cancer and papillary thyroid cancer.
- •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.
Arms & Interventions
IC plus CC plus IMRT
Induction chemotherapy followed by Intensity-modulated radiotherapy plus concurrent chemotherapy
Intervention: Induction chemotherapy plus Concurrent chemotherapy
IC plus CC plus IMRT
Induction chemotherapy followed by Intensity-modulated radiotherapy plus concurrent chemotherapy
Intervention: IMRT
CC plus IMRT
Intensity-modulated radiotherapy plus concurrent chemotherapy alone
Intervention: Concurrent chemotherapy
CC plus IMRT
Intensity-modulated radiotherapy plus concurrent chemotherapy alone
Intervention: IMRT
Outcomes
Primary Outcomes
Failure Free Survival
Time Frame: Two years
The absence of relapse, non-relapse mortality or addition of another systemic therapythe last follow-up if there is no disease progression.
Secondary Outcomes
- Overall survial(Two years)