Optimized Treatment Strategies for Early and Medium Stage Nasopharyngeal Carcinoma
A Randomized Multicenter Phase II/III Study of Optimized Treatment Strategies for Stage II and III Nasopharyngeal Carcinoma
1 other identifier
interventional
120
1 country
1
Brief Summary
The purpose of this study is to optimize treatment strategies for patients with stage II and III nasopharyngeal carcinoma, reduce the side effects related to treatment and improve the quality of life.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_2
Started Jun 2019
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
March 31, 2019
CompletedFirst Posted
Study publicly available on registry
April 9, 2019
CompletedStudy Start
First participant enrolled
June 15, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 1, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
May 1, 2025
CompletedJanuary 29, 2021
January 1, 2021
1.9 years
March 31, 2019
January 28, 2021
Conditions
Outcome Measures
Primary Outcomes (1)
progress free survival
5 years
Secondary Outcomes (3)
overall survival
5 years
local-regional control
5 years
complete response
13 weeks
Study Arms (2)
Induction chemotherapy(IC)+IMRT
EXPERIMENTALInduction chemotherapy for two cycles, the patients with complete response will receive 60 Gy to the gross target volume of nasopharynx, partial response 64 Gy, and the absence of response will receive concurrent chemoradiotherapy as the same as CCRT arm
Concurrent chemoradiotherapy(CCRT)
ACTIVE COMPARATORcisplatin 100mg/m2 IV on d1 of each 21 days for two cycles at least and 70 Gy radiotherapy
Interventions
Induction CT: Docetaxel 75mg/m2 IV on d1, every 21 days for two cycles
Induction chemotherapy:cisplatin 75mg/m2 IV on d1,every 21 days for two cycles.Concurrent chemoradiotherapy:cisplatin 100mg/m2 IV on d1 of each 21 days for at least two cycles during 70 Gy radiotherapy
IC+IMRT arm:the patients with complete response will receive 60Gy to the gross target volume of nasopharynx, partial response 64Gy, and the absence of response or stable will receive 70Gy. CCRT arm: 70Gy to the gross target volume of nasopharynx.
Eligibility Criteria
You may qualify if:
- Pathology confirmed nasopharyngeal squamous cell carcinoma.
- Aged 18 to 70 years old;
- Stage II-III (T1N1M0，T2-3N0-1M0) diseases according to 8th AJCC Staging and the shortest diameter of the largest lymph node involved is no more than 3cm;
- KPS≥70;
- Have measurable lesions on CT/MRI before treatment;
- Treatment for the first time;
- At least 6 months lifetime was expected;
- Adequate laboratory indexes, defined as follows: Hemoglobin \> 120g/L, WBC \> 4.0x10\*9/L, Plt \> 100x10\*9/L \< 2, all indexes of liver and kidney function ≤ 1.25 times of the institutional upper limit of normal value, no hearing loss;
- Can understand and sign the consent
- Have follow up condition
You may not qualify if:
- Past malignancies history (except for stage I non-melanoma skin cancer or cervical carcinoma in situ)
- Previously treatment for cancer
- Pregnant or breeding woman, female without contraception
- Enrolling in other drug trials
- Severe comorbidities including myocardial infarction, arrhythmia, cerebral vascular disease, ulceration disease, mental disease and uncontrolled diabetes
- Without follow up
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Chinese Academy of Medical Sciences
Beijin, 100021, China
Related Publications (4)
Xu C, Sun R, Tang LL, Chen L, Li WF, Mao YP, Zhou GQ, Guo R, Lin AH, Sun Y, Ma J, Hu WH. Role of sequential chemoradiotherapy in stage II and low-risk stage III-IV nasopharyngeal carcinoma in the era of intensity-modulated radiotherapy: A propensity score-matched analysis. Oral Oncol. 2018 Mar;78:37-45. doi: 10.1016/j.oraloncology.2018.01.008. Epub 2018 Feb 20.
PMID: 29496056BACKGROUNDLiu YC, Wang WY, Twu CW, Jiang RS, Liang KL, Lin PJ, Lin JW, Lin JC. Comparison Long-term Outcome of Definitive Radiotherapy plus Different Chemotherapy Schedules in Patients with Advanced Nasopharyngeal Carcinoma. Sci Rep. 2018 Jan 11;8(1):470. doi: 10.1038/s41598-017-18713-z.
PMID: 29323141BACKGROUNDYao JJ, Yu XL, Zhang F, Zhang WJ, Zhou GQ, Tang LL, Mao YP, Chen L, Ma J, Sun Y. Radiotherapy with neoadjuvant chemotherapy versus concurrent chemoradiotherapy for ascending-type nasopharyngeal carcinoma: a retrospective comparison of toxicity and prognosis. Chin J Cancer. 2017 Mar 6;36(1):26. doi: 10.1186/s40880-017-0195-6.
PMID: 28264724BACKGROUNDXu C, Zhang LH, Chen YP, Liu X, Zhou GQ, Lin AH, Sun Y, Ma J. Chemoradiotherapy Versus Radiotherapy Alone in Stage II Nasopharyngeal Carcinoma: A Systemic Review and Meta-analysis of 2138 Patients. J Cancer. 2017 Jan 15;8(2):287-297. doi: 10.7150/jca.17317. eCollection 2017.
PMID: 28243333BACKGROUND
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Junlin Yi, professor
Cancer Institute and Hospital, Chinese Academy of Medical Sciences
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- professor
Study Record Dates
First Submitted
March 31, 2019
First Posted
April 9, 2019
Study Start
June 15, 2019
Primary Completion
May 1, 2021
Study Completion
May 1, 2025
Last Updated
January 29, 2021
Record last verified: 2021-01