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| Name | Class |
|---|---|
| Sun Yat-Sen University Cancer Center | OTHER |
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To evaluate the long-term local control, survival rate, acute and late radiation related toxicities, quality of life after reducing high risk primary tumor clinical target volumes (CTVp1) in non-metastatic nasopharyngeal carcinoma treated with IMRT.
This phase 3, multicenter,randomized controlled clinical trial recruits patients with newly-diagnosed non-metastatic nasopharyngeal carcinoma patients treated with IMRT. The intervention is delineating high risk primary tumor clinical target volumes (CTVp1) as GTV+5mm or GTV+5mm+whole nasopharynx. The objective is to compare the long-term local control, survival rate, acute and late radiation related toxicities between the two groups.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Reduction CTVp1 | Experimental | CTVp1=GTVp+5mm |
|
| Non-reduction CTVp1 | Placebo Comparator | CTVp1=GTVp+5mm+whole nasopharynx |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Reduction CTVp1 | Radiation | High Risk Primary Tumor Clinical Target Volumes (CTVp1) is defined as 5mm margin from GTVp,including pre-induction chemotherapy tumor extension( CTVp1=GTVp+5mm) |
| Measure | Description | Time Frame |
|---|---|---|
| Local Relapse-free Survival(LRFS) | the time from randomization to documented local recurrence or death from any cause | 3 years |
| Incidence of hearing impairment worse than graded 2 | audiometry and symptoms graded according to the CTCAE (version 5.0). | 3 years |
| Measure | Description | Time Frame |
|---|---|---|
| Overall survival (OS) | the time from randomization to documented death from any cause | 3 years |
| Regional Relapse-free Survival(RRFS) | the time from randomization to documented regional recurrence or death from any cause |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Gui-qiong Xu | Contact | +8613528109888 | donna_shee@163.com |
| Name | Affiliation | Role |
|---|---|---|
| Gui-qiong Xu | Zhongshan People's Hospital, Guangdong, China | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Zhongshan City People's Hospital | Recruiting | Zhongshan | Guangdong | 528403 | China |
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| ID | Term |
|---|---|
| D000077274 | Nasopharyngeal Carcinoma |
| ID | Term |
|---|---|
| D002277 | Carcinoma |
| D009375 | Neoplasms, Glandular and Epithelial |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
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| Non-reduction CTVp1 | Radiation | High Risk Primary Tumor Clinical Target Volumes (CTVp1) is defined as whole nasopharynx as well as 5mm margin from GTVp( CTVp1=GTVp+5mm+whole nasopharynx) |
|
| 3 years |
| Distant metastasis-free survival (DMFS) | calculated from randomization to documented distant metastasis or death | 3 years |
| Acute toxicities | Occur within 3 months after IMRT according Common Terminology Criteria for Adverse Events Version 5.0 | 3 months |
| Late toxicities | 3 months after completion of radiotherapy graded according to both the Radiation Therapy Oncology Group criteria and the CTCAE (version 5.0) | 3 years |
| Functional Assessment of Cancer Therapy-Head and Neck questionnaire (EORTC QLQ-H&N35) | Patient reported quality-of-life data and higher scores indicated more severe symptoms | 3 years |
| Functional Assessment of Cancer Therapy-Head and Neck questionnaire (EORTC QLQ-C30) | Patient reported quality-of-life data and higher scores indicated more severe symptoms | 3 years |
| radiation-induced otitis media with effusion (OME) | Evaluated by tympanometry | 3 years |
| V60Gy | Volume that received at least 60Gy | 3 years |
| 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 |