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

Sponsor

Sun Yat-sen University (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT05622474

Collaborator

Affiliated Cancer Hospital & Institute of Guangzhou Medical University (Other), Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University (Other), Fifth Affiliated Hospital, Sun Yat-Sen University (Other), First People's Hospital of Foshan (Other)

236

Enrollment

Location

Arms

Anticipated Duration (Months)

3.2

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Nasopharyngeal Carcinoma	Drug: Induction chemotherapy plus Concurrent chemotherapy Drug: Concurrent chemotherapy Radiation: IMRT	N/A

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 Design

Study Type:

Interventional

Anticipated Enrollment :

236 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Double (Participant, Investigator)

Primary Purpose:

Treatment

Official Title:

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

Anticipated Study Start Date :

Nov 30, 2022

Anticipated Primary Completion Date :

Dec 31, 2025

Anticipated Study Completion Date :

Dec 31, 2028

Arms and Interventions

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	Drug: Concurrent chemotherapy Concurrent chemotherapy: DDP -- Cisplatin 25 mg/m2, D1-3 , every 3 weeks for 2 cycles during radiation. Radiation: IMRT Radical radiation: Intensity-modulated radiotherapy

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

Drug: Concurrent chemotherapy

Concurrent chemotherapy: DDP -- Cisplatin 25 mg/m2, D1-3 , every 3 weeks for 2 cycles during radiation.

Radiation: IMRT

Radical radiation: Intensity-modulated radiotherapy

Outcome Measures

Primary Outcome Measures

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.

Secondary Outcome Measures

Overall survial [Two years]
The time from randomization until death from any cause.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 70 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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:

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 ≥ 9.3. 4.ECOG Score (PS score) 0 or 1. 5.Neutrophil count > 1.510^9/L, hemoglobin > 90g/L, and platelet count > 10010^9/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:

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.