Reduced-dose Radiotherapy for Low-risk Stage III Patients With Nasopharyngeal Carcinoma
A Phase II Trial of Induction Chemotherapy Followed by Cisplatin With Low Dose vs. Standard Dose IMRT in Stage III Nasopharyngeal Carcinoma Patients With Pretreatment EBV DNA<4000 Copy/ml
1 other identifier
interventional
215
1 country
1
Brief Summary
To study the 2-year PFS (progression-free survival) of patients with stage III nasopharyngeal carcinoma of pretreatment EBV DNA\<4000 copy/ml treated with induction chemotherapy followed by two different doses of intensity-modulated radiation therapy and cisplatin.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2
Started Oct 2018
Longer than P75 for phase_2
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
June 8, 2018
CompletedFirst Posted
Study publicly available on registry
September 13, 2018
CompletedStudy Start
First participant enrolled
October 19, 2018
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 31, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
December 30, 2023
CompletedAugust 24, 2021
August 1, 2021
3.2 years
June 8, 2018
August 23, 2021
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
PFS(progression free survival)
Defined from date of registration to date of first documentation of progression and/or distant metastasis,or death due to any cause. The primary study population for this endpoint is patients who were confirmed post-induction CR /PR and EBV DNA=0 and subsequently received 60Gy radiation therapy.
2 years
Secondary Outcomes (10)
Overall Survival(OS)
2 years
Locoregional relapse-free survival(LRFS)
2 years
Distant metastasis-free survival(DMFS)
2 years
Overall response rate
2 years
Incidence of acute toxicity
2 years
- +5 more secondary outcomes
Study Arms (2)
Reduced dose group
EXPERIMENTALAfter 2 cycles of induction chemotherapy with Paclitaxel Liposome, Cisplatin and 5-Fluorouracil, patients undergo low-dose intensity-modulated radiotherapy (IMRT) 5 days per week for approximately 6 weeks (30 fractions). Patients also receive cisplatin once per three week for 3 cycles.
Standard dose group
EXPERIMENTALAfter 2 cycles of induction chemotherapy with Paclitaxel Liposome,Cisplatin and 5-Fluorouracil, patients undergo standard-dose intensity-modulated radiotherapy (IMRT) 5 days per week for approximately 6 weeks (33 fractions). Patients also receive cisplatin once per three week for 3 cycles.
Interventions
Patients undergo low-dose OR standard dose IMRT based on their radiographic response to induction chemotherapy
Patients receive Paclitaxel liposome by 135mg/m2 with a total of two cycles.
Patients receive Cisplatin by 25mg/m2 on day1-day3 with a total of two cycles as induction chemotherapy ; patients receive cisplatin by 100mg/m2 with a total of three cycles as concurrent chemotherapy.
Patients receive 5-Fluorouracil by 3750mg/m2 civ120h with a total of three cycles.
Eligibility Criteria
You may qualify if:
- Pathological diagnosis of NPC(WHO II or III).
- Stage III（8thAJCC/UICC staging system) and pretreatment EBVDNA\<4000opies/ml.
- Aged 18-70 years。
- ECOG = 0-1。
- HGB≥90 g/L，WBC≥4×109 /L，PLT≥100×109 /L.
- ALT,AST\<2.5 fold of ULN；TBIL\<2.0×ULN。
- CCR≥60ml/min or Cr\<1.5×ULN。
- Signed informed consent
You may not qualify if:
- WHO Type keratinizing squamous cell carcinoma or basaloid squamous cell carcinoma.
- Age \<18 or \>70years.
- Treatment with palliative intent.
- Prior malignancy except adequately treated basal cell or squamous cell skin cancer, in situ cervical cancer.
- Pregnancy or lactation.
- History of previous radiotherapy (except for non-melanomatous skin cancers outside intended RT treatment volume).
- Prior chemotherapy or surgery (except diagnostic) to primary tumor or nodes.
- Any severe intercurrent disease, which may bring unacceptable risk or affect the compliance of the trial, 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)
Hai Qiang Mai
Guangzhou, Guangdong, 510060, China
Related Publications (1)
Guo SS, Yang JH, Sun XS, Liu LZ, Yang ZC, Liu LT, Liu SL, Li XY, Lv XF, Luo DH, Li JB, Liu Q, Wang P, Guo L, Mo HY, Sun R, Yang Q, Liang YJ, Jia GD, Zhao C, Chen QY, Tang LQ, Mai HQ. Reduced-dose radiotherapy for Epstein-Barr virus DNA selected staged III nasopharyngeal carcinoma: A single-arm, phase 2 trial. Eur J Cancer. 2023 Nov;194:113336. doi: 10.1016/j.ejca.2023.113336. Epub 2023 Sep 9.
PMID: 37801967DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY CHAIR
Hai Qiang Mai, MD.PHD
Sun Yat-sen University
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Professor
Study Record Dates
First Submitted
June 8, 2018
First Posted
September 13, 2018
Study Start
October 19, 2018
Primary Completion
December 31, 2021
Study Completion
December 30, 2023
Last Updated
August 24, 2021
Record last verified: 2021-08
Data Sharing
- IPD Sharing
- Will not share