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| Name | Class |
|---|---|
| National Cancer Centre, Singapore | OTHER |
| Affiliated Cancer Hospital & Institute of Guangzhou Medical University | OTHER |
| Zhongshan People's Hospital, Guangdong, China | OTHER |
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Through multicenter, open-label, randomised clinical trials, we intend to demonstrate that radiotherapy with reduced dose could significantly reduce the incidence of radiotherapy toxicities, improve the quality of life of patients while ensuring the tumor control rates for NPC patients staged as II-III who are sensitive to induction chemotherapy (imaging evaluation of CR/PR and EBV DNA copy number decreased to 0 copies/mL after induction chemotherapy)
Through multicenter, open-label, randomised clinical trials, patients with NPC staged as II-III with CR/PR according to RECIST criteria and EBV DNA decreased to 0 copies/mL after 3 cycles of GP induction chemotherapy will be randomized into experimental group to receive IMRT of reduced dose (prescribed dose, 63.6 Gy, 2.12 Gy per fractions, 30 fractions) and control group to receive IMRT of conventional dose (prescribed dose, 69.96 Gy, 2.13 Gy per time, 33 fractions). Two cycles of cisplatin chemotherapy will be performed during IMRT. The efficacy, toxicity, and quality of life of patients between the two groups will be compared.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Reduced dosage IMRT group | Experimental | 3 cycles of gemcitabin and cisplatin induction chemotherapy plus concurrent cheomtherapy with IMRT dosage of 63.6 Gy |
|
| Conventional dosage IMRT group | Active Comparator | 3 cycles of gemcitabin and cisplatin induction chemotherapy plus concurrent cheomtherapy with IMRT dosage of 69.96 Gy |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| reduced dosage IMRT | Radiation |
|
| Measure | Description | Time Frame |
|---|---|---|
| Progress-free survival (PFS) | Defined as time from randomization to locoregional or distant metastasis relapse or death from any cause, whichever occurred first. | 3 years |
| Measure | Description | Time Frame |
|---|---|---|
| Overall Survival (OS) | Defined as the time interval from randomization to death due to any cause. | 3 years |
| Distant Metastasis-Free Survival (DMFS) | Defined as the time interval from randomisation to the date of first distant metastases. |
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Inclusion Criteria:
Histologically confirmed non-keratinizing nasopharyngeal carcinoma (differentiated or undifferentiated type, i.e., WHO type II or type III).
Staged as T1-3N1-2M0, T2-3N0M0 (stage II-III) at diagnosis (according to the 8th AJCC edition).
Aged between 18-70 years.
Karnofsky scale (KPS)≥70.
Normal bone marrow function.
Evaluated as PR or CR after 3 cycles of GP induction chemotherapy.
EBV DNA copy number decreased to 0 copies/mL after 3 cycles of GP induction chemotherapy.
Normal liver and kidney function:
Given written informed consent.
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Ming-Yuan Chen, MD, PhD | Contact | 86-20-87343624 | chmingy@mail.sysu.edu.cn | |
| Rui You, MD, PhD | Contact | 86-13580439820 | yourui@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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| Yuebei People's Hospital |
| OTHER |
| Wuzhou Red Cross Hospital | OTHER |
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|
| conventional dosage IMRT | Radiation |
|
|
| 3 years |
| Locoregional Relapse-Free Survival (LRRFS) | Defined as the time from randomisation to the date of first locoregional relapse. | 3 years |
| Incidence of treatment related acute complications | The proportion of patients with treatment related acute complications according to NCI-CTC5.0 criteria and RTOG criteria. | up to 1 years |
| Incidence of treatment related late complications | The proportion of patients with treatment related late complications according to NCI-CTC5.0 criteria and RTOG criteria. | up to 3 years |
| Score of survival quality according to the EORTC Quality of Life Questionnaire (QLQ)-C30 (V3.0) | Score of survival quality according to the EORTC Quality of Life Questionnaire (QLQ)-C30 (V3.0) before treatment, during treatment, after treatment. | up to 3 years |
| Score of survival quality according to the EORTC Quality of Life Questionnaire Head and Neck (The QLQ-H&N35) | Score of survival quality according to the EORTC Quality of Life Questionnaire Head and Neck (The QLQ-H&N35) before treatment, during treatment, after treatment. | up to 3 years |
| Cancer Center of Guangzhou Medical University | Not yet recruiting | Guangzhou | Guangdong | 510095 | China |
|
| Yuebei People's Hospital | Not yet recruiting | Shaoguan | Guangdong | 512025 | China |
|
| Zhongshan People's Hospital | Recruiting | Zhongshan | Guangdong | 528403 | China |
|
| Wuzhou Red Cross Hospital | Not yet recruiting | Wuzhou | Guangxi | 543002 | China |
|
| National Cancer Centre Singapore | Not yet recruiting | Singapore | 169610 | Singapore |
|
| 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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