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Trial 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
NCT ID:
NCT05622474
Condition:
Nasopharyngeal Carcinoma
Conditions: Official terms:
Carcinoma
Nasopharyngeal Carcinoma
Conditions: Keywords:
Nasopharyngeal Carcinoma
T3N1M0
Induction Chemotherapy
Concurrent Chemoradiotherapy
Study type:
Interventional
Study phase:
N/A
Overall status:
Not yet recruiting
Study design:
Allocation:
Randomized
Intervention model:
Parallel Assignment
Primary purpose:
Treatment
Masking:
Double (Participant, Investigator)
Intervention:
Intervention type:
Drug
Intervention name:
Induction chemotherapy plus Concurrent chemotherapy
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.
Arm group label:
IC plus CC plus IMRT
Intervention type:
Drug
Intervention name:
Concurrent chemotherapy
Description:
Concurrent chemotherapy: DDP -- Cisplatin 25 mg/m2, D1-3 , every 3 weeks for 2 cycles
during radiation.
Arm group label:
CC plus IMRT
Intervention type:
Radiation
Intervention name:
IMRT
Description:
Radical radiation: Intensity-modulated radiotherapy
Arm group label:
CC plus IMRT
Arm group label:
IC plus CC plus IMRT
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.
Criteria for 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:
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.
Gender:
All
Minimum age:
18 Years
Maximum age:
70 Years
Healthy volunteers:
No
Locations:
Facility:
Name:
Sun Yat-sen University Cancer Center
Address:
City:
Guangzhou
Zip:
510060
Country:
China
Start date:
November 30, 2022
Completion date:
December 31, 2028
Lead sponsor:
Agency:
Sun Yat-sen University
Agency class:
Other
Collaborator:
Agency:
Affiliated Cancer Hospital & Institute of Guangzhou Medical University
Agency class:
Other
Collaborator:
Agency:
Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
Agency class:
Other
Collaborator:
Agency:
Fifth Affiliated Hospital, Sun Yat-Sen University
Agency class:
Other
Collaborator:
Agency:
First People's Hospital of Foshan
Agency class:
Other
Source:
Sun Yat-sen University
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05622474
