Induction Chemotherapy Plus Radiotherapy Alone in Patients With Locoregionally Advanced Nasopharyngeal Carcinoma
1 other identifier
interventional
562
1 country
1
Brief Summary
The purpose of this study is to compare induction chemotherapy (TPF or GP) plus radiotherapy alone with induction chemotherapy plus concurrent chemoradiotherapy in patients with locoregionally advanced nasopharyngeal carcinoma (LA-NPC).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_3
Started Jun 2020
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
May 24, 2020
CompletedStudy Start
First participant enrolled
June 1, 2020
CompletedFirst Posted
Study publicly available on registry
June 4, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 30, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
May 30, 2025
CompletedJune 4, 2020
May 1, 2020
2 years
May 24, 2020
May 31, 2020
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Disease-free survival
Disease-free survival rate is calculated from the date of randomization to the date of treatment failure or death from any cause, whichever is first.
3-year
Secondary Outcomes (5)
Overall survival
3-year
Locoregional recurrence-free survival
3-year
Distant metastasis-free survival
3-year
Objective response rates after treatments
At the end of Cycle 3 of induction chemotherapy (each cycle is 21 days) and 16 weeks after completion of radiotherapy
Number of participants with adverse events
Every week during treatment, up to 4 weeks after treatment.
Study Arms (2)
IC plus RT
EXPERIMENTALPatients receive GP(gemcitabine+cisplatin) or TPF(docetaxel+cisplatin+fluorouracil) every three weeks for three cycles before the radiotherapy, and then receive radical radiotherapy and cisplatin (100mg/m\^2) every three weeks for three cycles during radiotherapy.
IC plus CCRT
ACTIVE COMPARATORPatients receive GP(gemcitabine+cisplatin) or TPF(docetaxel+cisplatin+fluorouracil) every three weeks for three cycles before the radiotherapy, and then receive radical radiotherapy.
Interventions
Patients receive GP gemcitabine (1000 mg/m\^2 d1,8) and cisplatin (80mg/m\^2 d1) or TPF docetaxel (60mg/m\^2 on day 1), cisplatin (60mg/m\^2 on day 1) and fluorouracil (600mg/m\^2 on Days 1 to 5) every three weeks for three cycles before the radiotherapy.
Intensity modulated-radiotherapy (IMRT) is given as 2.0 Gy per fraction with five daily fractions per week for 6-7 weeks to a total dose of 66 Gy or greater to the primary tumor.
Intensity modulated-radiotherapy (IMRT) is given as 2.0-2.30 Gy per fraction with five daily fractions per week for 6-7 weeks to a total dose of 66 Gy or greater to the primary tumor, concurrently with cisplatin 100 mg/m\^2 every 3 weeks for 3 cycles.
Eligibility Criteria
You may qualify if:
- Newly pathologically confirmed as non-keratinizing nasopharyngeal carcinoma (differentiated or undifferentiated, ie WHO type II or III).
- Age ≥ 18 and ≤ 65 years old.
- Tumor staged as III/IVa (according to the 8th AJCC edition).
- No evidence of distant metastasis (M0).
- Satisfactory performance status: Karnofsky scale (KPS) ≥ 70.
- Adequate marrow: White blood cells (WBC) ≥ 4 × 10\^9/L, hemoglobin (HGB) ≥ 90 g/L, platelets (PLT) ≥ 100 × 10\^9/L (or within the normal range of the laboratory)
- 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 ≤ ULN.
- Adequate renal function: creatinine clearance ≥ 60 ml/min.
- Written informed consent.
You may not qualify if:
- WHO Type keratinizing squamous cell carcinoma or basaloid squamous cell carcinoma.
- Age \> 65 or \< 18.
- Treatment with palliative intent.
- Previous history of malignant tumors, well-treated basal cell carcinoma or squamous cell carcinoma and cervical carcinoma in situ outer.
- Pregnancy or lactation.
- History of previous RT (except for non-melanomatous skin cancers outside intended RT treatment volume), chemotherapy or surgery (except diagnostic) to primary tumor or nodes.
- Any other serious diseases, which may bring greater risk or affect the compliance of the test, for example, unstable cardiac disease requiring treatment, renal disease, chronic hepatitis, diabetes with poor control (fasting plasma glucose \> 1.5×ULN), and emotional disturbance.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Xingchen Peng
Chengdu, Sichuan, 610041, China
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Xingchen Peng, MD, PhD
West China Hospital
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
- PRINCIPAL INVESTIGATOR
- PI Title
- Principal Investigator
Study Record Dates
First Submitted
May 24, 2020
First Posted
June 4, 2020
Study Start
June 1, 2020
Primary Completion
May 30, 2022
Study Completion
May 30, 2025
Last Updated
June 4, 2020
Record last verified: 2020-05
Data Sharing
- IPD Sharing
- Will not share