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In this multicenter, prospective, randomized, controlled, non-inferiority Phase III clinical trial, treatment-naïve patients with nasopharyngeal carcinoma (NPC) without metastasis will be enrolled for curative radiotherapy. The participants will be randomly assigned to two groups. The experimental group will receive online adaptive radiotherapy (ART) during the radiotherapy process, with a smaller PTV margin, while the control group will use original treatment plan during full-course radiotherapy, with a PTV margin of 3 mm. The study aims to compare the survival, adverse events, and quality of survival between the two groups, with the primary endpoint being the locoregional recurrence-free survival rate. The main objective is to determine the role of online ART in nasopharyngeal carcinoma, elucidating its potential to alleviate radiation toxicity in patients while ensuring treatment efficacy.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Conventional radiotherapy with conventional margins w or w/o chemotherapy | Active Comparator | Complete the full course of radiotherapy using the original treatment plan. PTV margin: 3mm. |
|
| Radiotherapy with smaller margin and online adaptive radiotherapy w or w/o chemotherapy | Experimental | Throughout the course of radiotherapy, the treatment plan is adjusted online based on the anatomical and dosimetric changes in the target volumes and organs at risk of the patients. PTV margin: smaller. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Intensity modulated radiation therapy (IMRT) with conventional planning target volume (PTV) margin and without online adaptive radiotherapy | Radiation | Radiation: Complete the full course of radiotherapy using the original treatment plan. Planning target volume (PTV) margin: 3mm; |
| Measure | Description | Time Frame |
|---|---|---|
| Locoregional recurrence-free survival | locoregional progression free survival | 3-year |
| Measure | Description | Time Frame |
|---|---|---|
| Overall survival | overall survival | 3-year |
| Distant metastasis free survival | Distant metastasis free survival | 3-year |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Yu-xian Yang, MD | Contact | +86 147 4892 2370 | yangyx1@sysucc.org.cn | |
| Guan-qun Zhou, PhD | Contact | +86 159 1437 2887 | zhougq@sysucc.org.cn |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Sun Yat-sen University Cancer Center | Recruiting | Guangzhou | Guangdong | 510060 | China |
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|
| Chemotherapy | Drug | Chemotherapy: If given, platinum-based. |
|
| Intensity modulated radiation therapy (IMRT) with smaller planning target volume (PTV) margin and online adaptive radiotherapy | Radiation | Radiation: During the course of radiotherapy, the treatment plan is adjusted online based on the anatomical and dosimetric changes in the target volumes and organs at risk of patients. planning target volume (PTV) margin: smaller. |
|
| Chemotherapy | Drug | Chemotherapy: If given, platinum-based |
|
| Rate of acute radiation-induced events according to Common Terminology Criteria for Adverse Events (CTCAE 5.0) | Acute radiation-induced events. The minimum and maximum values are 0 and 5 respectively. The higher scores mean a worse outcome. | 3 months |
| Rate of late radiation-induced events according to Common Terminology Criteria for Adverse Events (CTCAE 5.0). | Late radiation-induced events. The minimum and maximum values are 0 and 5 respectively. The higher scores mean a worse outcome. | 3-year |
| European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire-Head and Neck 35 Version 1.0 (EORTC QLQ-HN35 V1.0) | The minimum and maximum values are 0 and 4 respectively. The higher scores mean a worse outcome. | From baseline to 3 years post-radiotherapy |
| and National Cancer Institute Patient-Reported Outcomes version of the Common Terminology Criteria for Adverse Events Version 1.0 (NCI-PRO-CTCAE V1.0.) | The minimum and maximum values are 0 and 5 respectively. The higher scores mean a worse outcome. | From baseline to 3 years post-radiotherapy |
| ID | Term |
|---|---|
| D000077274 | Nasopharyngeal Carcinoma |
| ID | Term |
|---|---|
| D002277 | Carcinoma |
| D009375 | Neoplasms, Glandular and Epithelial |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D009303 | Nasopharyngeal Neoplasms |
| D010610 | Pharyngeal Neoplasms |
| D010039 | Otorhinolaryngologic Neoplasms |
| D006258 | Head and Neck Neoplasms |
| D009371 | Neoplasms by Site |
| D009302 | Nasopharyngeal Diseases |
| D010608 | Pharyngeal Diseases |
| D009057 | Stomatognathic Diseases |
| D010038 | Otorhinolaryngologic Diseases |
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| ID | Term |
|---|---|
| D050397 | Radiotherapy, Intensity-Modulated |
| D004358 | Drug Therapy |
| ID | Term |
|---|---|
| D020266 | Radiotherapy, Conformal |
| D011881 | Radiotherapy, Computer-Assisted |
| D011878 | Radiotherapy |
| D013812 | Therapeutics |
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