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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Induction chemotherapy(IC)+IMRT | Experimental | 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) | Active Comparator | cisplatin 100mg/m2 IV on d1 of each 21 days for two cycles at least and 70 Gy radiotherapy |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Docetaxel | Drug | Induction CT: Docetaxel 75mg/m2 IV on d1, every 21 days for two cycles |
|
| Measure | Description | Time Frame |
|---|---|---|
| progress free survival | 5 years |
| Measure | Description | Time Frame |
|---|---|---|
| overall survival | 5 years | |
| local-regional control | 5 years | |
| complete response |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Junlin Yi, M.D | Contact | 008601366121799 | junlinyi@sohu.com |
| Name | Affiliation | Role |
|---|---|---|
| Junlin Yi, professor | Cancer Institute and Hospital, Chinese Academy of Medical Sciences | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Chinese Academy of Medical Sciences | Recruiting | Beijin | 100021 | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 29496056 | Background | 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. | |
| 29323141 |
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| Cisplatin | Drug | 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 |
|
|
| IMRT | Radiation | 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. |
|
|
efficacy will be measured by RECIST1.1
| 13 weeks |
| Liu 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. |
| 28264724 | Background | Yao 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. |
| 28243333 | Background | Xu 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. |
| ID | Term |
|---|---|
| D000077143 | Docetaxel |
| D002945 | Cisplatin |
| D050397 | Radiotherapy, Intensity-Modulated |
| ID | Term |
|---|---|
| D043823 | Taxoids |
| D043822 | Cyclodecanes |
| D003516 | Cycloparaffins |
| D006840 | Hydrocarbons, Alicyclic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
| D004224 | Diterpenes |
| D013729 | Terpenes |
| D017606 | Chlorine Compounds |
| D007287 | Inorganic Chemicals |
| D017672 | Nitrogen Compounds |
| D017671 | Platinum Compounds |
| D020266 | Radiotherapy, Conformal |
| D011881 | Radiotherapy, Computer-Assisted |
| D011878 | Radiotherapy |
| D013812 | Therapeutics |
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