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

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Nasopharyngeal Carcinoma
• Intervention / Treatment: Drug: Induction chemotherapy plus Concurrent chemotherapy; Radiation: IMRT; Drug: Concurrent chemotherapy

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.

• Study Type: Interventional
• Enrollment (Anticipated): 236
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Fang-Yun Xie, M.D; Phone Number: +86-020-87342618; Email: xiefy@sysucc.org.cn
• Study Contact Backup: Name: Pu-Yun OuYang, M.D; Phone Number: +86-020-87342618; Email: ouyangpy@sysucc.org.cn

Study Locations

• China
  • Guangdong
    • Guangzhou, Guangdong, China, 510060
      • Sun Yat-Sen University Cancer Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 70 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: IC plus CC plus IMRT; Induction chemotherapy followed by Intensity-modulated radiotherapy plus concurrent chemotherapy	Drug: 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.; Radiation: IMRT; Radical radiation: Intensity-modulated radiotherapy
Active Comparator: CC plus IMRT; Intensity-modulated radiotherapy plus concurrent chemotherapy alone	Radiation: IMRT; Radical radiation: Intensity-modulated radiotherapy; Drug: Concurrent chemotherapy; Concurrent chemotherapy: DDP -- Cisplatin 25 mg/m2, D1-3 , every 3 weeks for 2 cycles during radiation.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Failure Free Survival	The absence of relapse, non-relapse mortality or addition of another systemic therapythe last follow-up if there is no disease progression.	Two years

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Overall survial	The time from randomization until death from any cause.	Two years

Collaborators and Investigators

• Sponsor: Sun Yat-sen University
• Collaborators: Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University; Fifth Affiliated Hospital, Sun Yat-Sen University; First People's Hospital of Foshan; Affiliated Cancer Hospital & Institute of Guangzhou Medical University
• Investigators: Principal Investigator: Fang-Yun Xie, M.D, Sun Yat-sen University

Study record dates

Study Major Dates

• Study Start (Anticipated): November 30, 2022
• Primary Completion (Anticipated): December 31, 2025
• Study Completion (Anticipated): December 31, 2028

Study Registration Dates

• First Submitted: November 13, 2022
• First Submitted That Met QC Criteria: November 17, 2022
• First Posted (Actual): November 18, 2022

Study Record Updates

• Last Update Posted (Actual): November 18, 2022
• Last Update Submitted That Met QC Criteria: November 17, 2022
• Last Verified: November 1, 2022

More Information

Terms related to this study

• Keywords: Nasopharyngeal Carcinoma; Concurrent Chemoradiotherapy; Induction Chemotherapy; T3N1M0
• Additional Relevant MeSH Terms: Neoplasms by Histologic Type; Neoplasms; Neoplasms by Site; Neoplasms, Glandular and Epithelial; Pharyngeal Neoplasms; Otorhinolaryngologic Neoplasms; Head and Neck Neoplasms; Nasopharyngeal Diseases; Pharyngeal Diseases; Stomatognathic Diseases; Otorhinolaryngologic Diseases; Nasopharyngeal Neoplasms; Carcinoma; Nasopharyngeal Carcinoma
• Other Study ID Numbers: B2022-589

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No