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This study investigates whether administering reduced dose is non-inferior to standard dose radiotherapy in terms of 3-year locoregional relapse-free survival (LRRFS) rate for stage I nasopharyngeal carcinoma patients who are sensitive to radiotherapy.
All the patients receive intensity-modulated radiotherapy. If patients receive CR and EBV DNA undetectable when completing 50.88Gy radiation, they will continue to receive radiotherapy until 61.48Gy, then the patients would be randomised assigned ( 1:1 ) to reduced dose group (observation) or standard dose group (continue to receive radiotherapy until 69.96Gy). Patients with stage IA will receive radiotherapy alone, and patients with stage IB will receive concurrent chemoradiotherapy. For patients with stage IB, those assigned to reduced dose group will receive a total of 2 cycles cisplatin concurrent chemotherapy, with 100mg/m2 per cycle; those assigned to standard dose group will receive a total of 3 cycles cisplatin concurrent chemotherapy, with 100mg/m2 per cycle. This study investigates whether administering reduced dose is non-inferior to standard dose radiotherapy in terms of 3-year locoregional relapse-free survival (LRRFS) rate for stage I nasopharyngeal carcinoma patients who are sensitive to radiotherapy. The primary endpoint is 3-year locoregional relapse-free survival.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Reduced dose group | Experimental | Patients receive reduced dose radiotherapy. |
|
| Standard dose group | Active Comparator | Patients receive standard dose radiotherapy. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Reduced dose radiation | Radiation | Reduced dose group would receive 61.48Gy radiation. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Locoregional relapse-free survival | The time from randomization to either documented local and/or regional relapse or death from any cause,whichever occurred first. | 3 year |
| Measure | Description | Time Frame |
|---|---|---|
| Progression-free survival | Time from randomisation to any documented local or regional relapse, distant metastasis, or death from any cause, whichever occurr first. | 3 year |
| Overall survival | Time from randomisation to death from any cause or censored at the date of the last follow-up. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Hai-Qiang Mai, Dr. | Contact | +8602087343380 | maihq@sysucc.org.cn | |
| Qiu-Yan Chen, Dr. | Contact | +8602087343380 | chenqy@sysucc.org.cn |
| Name | Affiliation | Role |
|---|---|---|
| Hai-Qiang MD, Dr. | Sun Yat-Sen University Cancer Center | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Sun Yat-sen University Cancer Centre | Recruiting | Guangzhou | Guangdong | 510060 | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 8751400 | Background | Mayr NA, Magnotta VA, Ehrhardt JC, Wheeler JA, Sorosky JI, Wen BC, Davis CS, Pelsang RE, Anderson B, Doornbos JF, Hussey DH, Yuh WT. Usefulness of tumor volumetry by magnetic resonance imaging in assessing response to radiation therapy in carcinoma of the uterine cervix. Int J Radiat Oncol Biol Phys. 1996 Jul 15;35(5):915-24. doi: 10.1016/0360-3016(96)00230-1. | |
| 32272183 |
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| Related Info | View source |
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| ID | Term |
|---|---|
| D011827 | Radiation |
| ID | Term |
|---|---|
| D055585 | Physical Phenomena |
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| Standard dose radiation | Radiation | Standard dose group would receive 69.96Gy radiation. |
|
| 3 year |
| Distant metastasis-free survival | Time from randomistion to distant metastasis or death from any cause. | 3 year |
| Incidence rate of adverse events (AEs) | Analysis of acute and late adverse events (AEs) are evaluated. Numbers of patients of treatment-related adverse events(acute toxicity) as assessed by CTCAE v5.0.Numbers of patients of late radiation toxicities were assessed using the Radiation Therapy Oncology Group and European Organization for Research and Treatment of Cancer late radiation morbidity scoring scheme. | 3 year |
| Change of quality of life (QoL) score | QoL scores were assessed for each scale by using the European Organisation for Research and Treatment of Cancer (EORTC ) Quality of Life Questionnaire C30 (QLQ-C30) and EORTC QLQ-Head and Neck module (QLQ-H&N35) at 61.48Gy radiotherapy, at 1 month after radiotherapy, at 6 month after radiotherapy, and 12 month after radiotherapy.All of the scales and items ranged in score from 0 to 100. A high score for a functional or global QoL scale represents a relatively high/healthy level of functional or global QoL, whereas a high score for a symptom scale or item represents a high number of symptoms or problems. | 1 year |
| Miao J, Di M, Chen B, Wang L, Cao Y, Xiao W, Wong KH, Huang L, Zhu M, Huang H, Huang S, Han F, Deng X, Xiang Y, Lv X, Xia W, Tan SH, Wee JTS, Guo X, Chua MLK, Zhao C. A Prospective 10-Year Observational Study of Reduction of Radiation Therapy Clinical Target Volume and Dose in Early-Stage Nasopharyngeal Carcinoma. Int J Radiat Oncol Biol Phys. 2020 Jul 15;107(4):672-682. doi: 10.1016/j.ijrobp.2020.03.029. Epub 2020 Apr 6. |
| 39388190 | Background | Pan JJ, Mai HQ, Ng WT, Hu CS, Li JG, Chen XZ, Chow JCH, Wong E, Lee V, Ma LY, Guo QJ, Liu Q, Liu LZ, Xu TT, Gong XC, Qiang MY, Au KH, Liu TC, Chiang CL, Xiao YP, Lin SJ, Chen YB, Guo SS, Wong CHL, Tang LQ, Xu ZY, Jia YZ, Peng WS, Hu LP, Lu TZ, Jiang F, Cao CN, Xu W, Ma J, Blanchard P, Williams M, Glastonbury CM, King AD, Patel SG, Seethala RR, Colevas AD, Fan DM, Chua MLK, Huang SH, O'Sullivan B, Lydiatt W, Lee AWM. Ninth Version of the AJCC and UICC Nasopharyngeal Cancer TNM Staging Classification. JAMA Oncol. 2024 Oct 10;10(12):1627-35. doi: 10.1001/jamaoncol.2024.4354. Online ahead of print. |
| 11919243 | Background | Rischin D, Corry J, Smith J, Stewart J, Hughes P, Peters L. Excellent disease control and survival in patients with advanced nasopharyngeal cancer treated with chemoradiation. J Clin Oncol. 2002 Apr 1;20(7):1845-52. doi: 10.1200/JCO.2002.07.011. |
| 26253488 | Background | Songthong AP, Kannarunimit D, Chakkabat C, Lertbutsayanukul C. A randomized phase II/III study of adverse events between sequential (SEQ) versus simultaneous integrated boost (SIB) intensity modulated radiation therapy (IMRT) in nasopharyngeal carcinoma; preliminary result on acute adverse events. Radiat Oncol. 2015 Aug 8;10:166. doi: 10.1186/s13014-015-0472-y. |
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