Back to resultsA Multicenter Randomized Controlled Clinical Study on the Treatment of T3N1M0 High Risk Nasopharyngeal Carcinoma With or Without Induction Chemotherapy Before Concurrent Radiotherapy and Chemotherapy
Primary Purpose
Nasopharyngeal Carcinoma
Status
Not yet recruiting
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
Induction chemotherapy plus Concurrent chemotherapy
Concurrent chemotherapy
IMRT
Sponsored by
About this trial
This is an interventional treatment trial for Nasopharyngeal Carcinoma focused on measuring Nasopharyngeal Carcinoma, T3N1M0, Induction Chemotherapy, Concurrent Chemoradiotherapy
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. 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 > 1.5*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: 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.
Sites / Locations
- Sun Yat-sen University Cancer Center
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
IC plus CC plus IMRT
CC plus IMRT
Arm Description
Induction chemotherapy followed by Intensity-modulated radiotherapy plus concurrent chemotherapy
Intensity-modulated radiotherapy plus concurrent chemotherapy alone
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
Overall survial
The time from randomization until death from any cause.
Full Information
NCT ID
NCT05622474
First Posted
November 13, 2022
Last Updated
November 17, 2022
Sponsor
Sun Yat-sen University
Collaborators
Affiliated Cancer Hospital & Institute of Guangzhou Medical University, Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University, Fifth Affiliated Hospital, Sun Yat-Sen University, First People's Hospital of Foshan
1. Study Identification
Unique Protocol Identification Number
NCT05622474
Brief 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
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
Study Type
Interventional
2. Study Status
Record Verification Date
November 2022
Overall Recruitment Status
Not yet recruiting
Study Start Date
November 30, 2022 (Anticipated)
Primary Completion Date
December 31, 2025 (Anticipated)
Study Completion Date
December 31, 2028 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Sun Yat-sen University
Collaborators
Affiliated Cancer Hospital & Institute of Guangzhou Medical University, Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University, Fifth Affiliated Hospital, Sun Yat-Sen University, First People's Hospital of Foshan
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. 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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Nasopharyngeal Carcinoma
Keywords
Nasopharyngeal Carcinoma, T3N1M0, Induction Chemotherapy, Concurrent Chemoradiotherapy
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
236 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
IC plus CC plus IMRT
Arm Type
Experimental
Arm Description
Induction chemotherapy followed by Intensity-modulated radiotherapy plus concurrent chemotherapy
Arm Title
CC plus IMRT
Arm Type
Active Comparator
Arm Description
Intensity-modulated radiotherapy plus concurrent chemotherapy alone
Intervention Type
Drug
Intervention Name(s)
Induction chemotherapy plus Concurrent chemotherapy
Intervention Description
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.
Intervention Type
Drug
Intervention Name(s)
Concurrent chemotherapy
Intervention Description
Concurrent chemotherapy: DDP -- Cisplatin 25 mg/m2, D1-3 , every 3 weeks for 2 cycles during radiation.
Intervention Type
Radiation
Intervention Name(s)
IMRT
Intervention Description
Radical radiation: Intensity-modulated radiotherapy
Primary Outcome Measure Information:
Title
Failure Free Survival
Description
The absence of relapse, non-relapse mortality or addition of another systemic therapythe last follow-up if there is no disease progression.
Time Frame
Two years
Secondary Outcome Measure Information:
Title
Overall survial
Description
The time from randomization until death from any cause.
Time Frame
Two years
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
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. 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 > 1.5*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:
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Fang-Yun Xie, M.D
Phone
+86-020-87342618
Email
xiefy@sysucc.org.cn
First Name & Middle Initial & Last Name or Official Title & Degree
Pu-Yun OuYang, M.D
Phone
+86-020-87342618
Email
ouyangpy@sysucc.org.cn
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Fang-Yun Xie, M.D
Organizational Affiliation
Sun Yat-sen University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Sun Yat-sen University Cancer Center
City
Guangzhou
State/Province
Guangdong
ZIP/Postal Code
510060
Country
China
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
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
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