Concurrent Chemoradiotherapy, Induction Chemotheray, Nasopharyngeal Squamous Cell Carcinoma, Reduce Treatment Intensity, Stage II, III
Conditions
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.
Interventions
DRUGDocetaxel
Induction CT: Docetaxel 75mg/m2 IV on d1, every 21 days for two cycles
DRUGCisplatin
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
RADIATIONIMRT
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.
Sponsors
Chinese Academy of Medical Sciences
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
Yes
Inclusion criteria
* 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
Exclusion criteria
* 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| progress free survival | 5 years |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| overall survival | 5 years | — |
| local-regional control | 5 years | — |
| complete response | 13 weeks | efficacy will be measured by RECIST1.1 |
Countries
China
Contacts
Primary ContactJunlin Yi, M.D
Outcome results
None listed