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
1 other identifier
interventional
236
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Nov 2022
Longer than P75 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
November 13, 2022
CompletedFirst Posted
Study publicly available on registry
November 18, 2022
CompletedStudy Start
First participant enrolled
November 30, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 31, 2025
CompletedStudy Completion
Last participant's last visit for all outcomes
December 31, 2028
ExpectedNovember 18, 2022
November 1, 2022
3.1 years
November 13, 2022
November 17, 2022
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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 Outcomes (1)
Overall survial
Two years
Study Arms (2)
IC plus CC plus IMRT
EXPERIMENTALInduction chemotherapy followed by Intensity-modulated radiotherapy plus concurrent chemotherapy
CC plus IMRT
ACTIVE COMPARATORIntensity-modulated radiotherapy plus concurrent chemotherapy alone
Interventions
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.
Concurrent chemotherapy: DDP -- Cisplatin 25 mg/m2, D1-3 , every 3 weeks for 2 cycles during radiation.
Eligibility Criteria
You may qualify if:
- Pathologically diagnosed with stage T3N1M0 nasopharyngeal cancer according to 2017 AJCC Cancer Staging Manual-8th Edition; not received anticancer treatment.
- 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,
- 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.
- ALT or AST level \< 2.5 times upper normal limit (upper limit of normal, ULN), bilirubin level \< 1.5 times ULN.
- Creatinine clearance level \> 60 ml/min. (Calculated according to Cockcroft Gault formula).
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Sun Yat-sen University Cancer Center
Guangzhou, Guangdong, 510060, China
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Fang-Yun Xie, M.D
Sun Yat-sen University
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Sun Yat-sen University Cancer Center
Study Record Dates
First Submitted
November 13, 2022
First Posted
November 18, 2022
Study Start
November 30, 2022
Primary Completion
December 31, 2025
Study Completion (Estimated)
December 31, 2028
Last Updated
November 18, 2022
Record last verified: 2022-11
Data Sharing
- IPD Sharing
- Will not share