Optimized Treatment Strategies for Early and Medium Stage Nasopharyngeal Carcinoma
- Conditions
- Stage II, IIINasopharyngeal Squamous Cell CarcinomaInduction ChemotherayConcurrent ChemoradiotherapyReduce Treatment Intensity
- Interventions
- Registration Number
- NCT03908372
- Lead Sponsor
- Chinese Academy of Medical Sciences
- 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.
- Detailed Description
The data came from conventional studies showed that the distant metastases and toxicities associated with concurrent chemoradiotherapy were main problems for patients with clinical stage II and III nasopharyngeal carcinoma. However, inductive chemotherapy can decrease the likelihood of emergence of distant metastasis and reduce treatment related toxicities as previous studies showed.
The role of inductive chemotherapy in screening low-risk nasopharyngeal carcinoma for less treatment intensity is under-evaluated in the era of intensity-modulated radiotherapy (IMRT). we hope to find the optimized treatment strategies by reducing the intensity of treatment according to the treatment response of inductive chemotherapy.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 120
- 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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Concurrent chemoradiotherapy(CCRT) IMRT cisplatin 100mg/m2 IV on d1 of each 21 days for two cycles at least and 70 Gy radiotherapy Induction chemotherapy(IC)+IMRT IMRT Induction 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 Induction chemotherapy(IC)+IMRT Docetaxel Induction 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 Induction chemotherapy(IC)+IMRT Cisplatin Induction 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) Cisplatin cisplatin 100mg/m2 IV on d1 of each 21 days for two cycles at least and 70 Gy radiotherapy
- Primary Outcome Measures
Name Time Method progress free survival 5 years
- Secondary Outcome Measures
Name Time Method overall survival 5 years local-regional control 5 years complete response 13 weeks efficacy will be measured by RECIST1.1
Trial Locations
- Locations (1)
Chinese Academy of Medical Sciences
🇨🇳Beijin, China