Sequential or Concurrent Chemoradiotherapy in Patients With Locoregionally Advanced NPC
Non-inferiority Prospective Randomized Trial Comparing Sequential Chemoradiotherapy With Concurrent Chemoradiotherapy in Patients With Locoregionally Advanced Nasopharyngeal Carcinoma
1 other identifier
interventional
420
1 country
1
Brief Summary
The purpose of this study is to compare the efficacy and safety of sequential chemoradiotherapy (induction chemotherapy + intensity-modulated radiotherapy +adjuvant chemotherapy) with induction chemotherapy plus concurrent chemoradiotherapy in patients with locoregionally advanced nasopharyngeal carcinoma (NPC), in order to confirm the value of sequential chemoradiotherapy in NPC patients.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_3
Started Jan 2018
Longer than P75 for phase_3
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
December 2, 2017
CompletedFirst Posted
Study publicly available on registry
December 8, 2017
CompletedStudy Start
First participant enrolled
January 1, 2018
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 30, 2024
CompletedStudy Completion
Last participant's last visit for all outcomes
December 30, 2024
CompletedMarch 4, 2022
February 1, 2022
6.8 years
December 2, 2017
February 16, 2022
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Failure-free survival
Failure-free survival is calculated from the date of randomisation to the date of treatment failure or death from any cause, whichever is first.
3-year
Grade III or more mucositis
Grade III or more mucositis during radiotherapy
From the start of radiotherapy to 30 days after radiotherapy
Secondary Outcomes (6)
Overall survival
3-year
Locoregional failure-free survival
3-year
Distant failure-free survival
3-year
Short-term treatment response
Two weeks after completion of induction chemotherapy. Three months after completion of the radiotherapy.
Number of participants with adverse events
up to 3 years
- +1 more secondary outcomes
Study Arms (2)
Induction chemotherapy+IMRT+adjuvant chemotherapy
EXPERIMENTALPatients receive gemcitabine (1000 mg/m² d1,8) and cisplatin (25 mg/m² d1-3) every 3 weeks for 2 cycles before radiotherapy, and then receive intensity modulated-radiotherapy (IMRT), followed by gemcitabine (1000 mg/m² d1,8) and cisplatin (25 mg/m² d1-3) every 3 weeks for 2 cycles.
Induction chemotherapy+IMRT and concurrent cisplatin
ACTIVE COMPARATORPatients receive gemcitabine (1000 mg/m² d1,8) and cisplatin (25 mg/m² d1-3) every 3 weeks for 2 cycles before radiotherapy, and then receive intensity modulated-radiotherapy (IMRT), concurrently with cisplatin 30 mg/m² every week.
Interventions
Patients receive gemcitabine (1000 mg/m² d1,8) and cisplatin (25mg/m² d1-3) every 3 weeks for 2 cycles before IMRT and after IMRT.
Intensity modulated-radiotherapy (IMRT) is given as 2.2 Gy per fraction with five daily fractions per week for 6-7 weeks to a total dose of 66 or 70.4 Gy to the primary tumor
Patients receive gemcitabine (1000 mg/m² d1,8) and cisplatin (25mg/m² d1-3) every 3 weeks for 2 cycles before concurrent chemoradiotherapy.
Intensity modulated-radiotherapy (IMRT) is given as 2.2 Gy per fraction with five daily fractions per week for 6-7 weeks to a total dose of 66 or 70.4Gy to the primary tumor, concurrently with cisplatin 30mg/m² every week.
Eligibility Criteria
You may qualify if:
- Patients with newly histologically confirmed non-keratinizing (according to WHO histologically type)
- Tumor staged as III-IVA (according to the 8th AJCC edition).
- Satisfactory performance status: Karnofsky scale (KPS) ≥ 70.
- Age between 18 and 65 years old.
- Adequate marrow: Neutrophil count ≥2000/μL, hemoglobin ≥90g/L and platelet count ≥100000/μL.
- Normal liver function test: Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST) ≤ 1.5×upper limit of normal (ULN) concomitant with alkaline phosphatase (ALP) ≤ 2.5×ULN, and bilirubin ≤ 1.5ULN.
- Adequate renal function: creatinine clearance ≥60 ml/min.
- Patients must be informed of the investigational nature of this study and give written informed consent.
You may not qualify if:
- Evidence of distant metastasis
- Prior chemotherapy, radiotherapy or surgery (except diagnostic) to primary tumor or nodes.
- Other previous or concomitant cancer.
- Pregnancy or lactation.
- Presence of an uncontrolled concomitant illness including, but not limited to, ongoing or active infection, immune deficiency, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia or emotional disturbance.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Chaosu Hulead
- Zhejiang Cancer Hospitalcollaborator
- Jiangxi Provincial Cancer Hospitalcollaborator
- First Affiliated Hospital of Wenzhou Medical Universitycollaborator
- Affiliated Hospital of Jiangnan Universitycollaborator
- Fujian Cancer Hospitalcollaborator
Study Sites (1)
Fudan University Shanghai Cancer Center
Shanghai, Shanghai Municipality, 200032, China
Related Publications (1)
Xue F, Ou D, Xie C, Lin S, Li J, Chen X, Zhang F, Ying H, Lu X, Shen C, Xu T, Ou X, Li W, Zhou X, Du C, Zhou C, Hu C, He X. Sequential vs Induction Plus Concurrent Chemoradiotherapy in Nasopharyngeal Carcinoma: A Randomized Clinical Trial. JAMA Oncol. 2025 Jul 24;11(9):1011-20. doi: 10.1001/jamaoncol.2025.2191. Online ahead of print.
PMID: 40705321DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR INVESTIGATOR
- PI Title
- chief physician
Study Record Dates
First Submitted
December 2, 2017
First Posted
December 8, 2017
Study Start
January 1, 2018
Primary Completion
September 30, 2024
Study Completion
December 30, 2024
Last Updated
March 4, 2022
Record last verified: 2022-02