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This is a multi-center, open-label, randomized controlled phase III clinical trial in primary diagnosed loco-regionally advanced nasopharyngeal carcinoma (NPC) patients. The purpose of this study is to evaluate the efficacy of induction chemotherapy (IC) combined with low-dose radiation and immune checkpoint inhibitor (ICI) followed by concurrent chemoradiotherapy (CCRT) versus IC+CCRT, and compare the treatment-related adverse events and quality of life in two groups.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Low-dose RT plus ICI | Experimental | Patients will receive induction chemotherapy plus low-dose radiotherapy and immuce checkpoint inhibitor then followed by concurrent chemoradiotehrapy. |
|
| IC+CCRT | Active Comparator | Patients will receive induction chemotherapy plus concurrent chemoradiotehrapy. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Intensity Modulated Radiation Therapy | Radiation | All target volumes will be outlined slice by slice on the axial contrast-enhanced CT with MR fusion images in the treatment planning system. The target volumes are defined in accordance with the International Commission on Radiation Units and Measurements Reports 83. The prescribed dose is 70-72 Gy to PTVp (Planning target volume of the primary tumor), 64-70 Gy to PTVn (Planning target volume of the lymph node), 60- 64Gy to PTV1 (High-risk planning target volume), and 54-58 Gy to PTV2 (Low-risk planning target volume) in 30-32 fractions. |
| Measure | Description | Time Frame |
|---|---|---|
| Progression free survival | From the date of randomization to local or regional recurrence, distant metastasis or any death | 3 years |
| Measure | Description | Time Frame |
|---|---|---|
| Overall survival | From the date of randomization to any death, with patients unavailable for follow-up censored at the date of last follow-up | 3 years |
| Local recurrence-free survival | From the date of randomization to local recurrence or any death |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Chong Zhao, MD, PhD | Contact | 02087342638 | zhaochong@sysucc.org.cn | |
| Jingjing Miao, MD | Contact | +8613631355201 | miaojj@sysucc.org.cn |
| Name | Affiliation | Role |
|---|---|---|
| Chong Zhao, MD, PhD | Sun Yat-Sen University Cancer Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Cancer Center, Sun Yat-sen University | Recruiting | Guangzhou | Guangdong | China |
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| Label | URL |
|---|---|
| Home Page of Cancer Center, Sun Yat-sen University | View source |
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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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| ID | Term |
|---|---|
| D050397 | Radiotherapy, Intensity-Modulated |
| D004358 | Drug Therapy |
| D060828 | Induction Chemotherapy |
| D000093542 | Gemcitabine |
| D002945 | Cisplatin |
| D000082082 | Immune Checkpoint Inhibitors |
| D011878 | Radiotherapy |
| ID | Term |
|---|---|
| D020266 | Radiotherapy, Conformal |
| D011881 | Radiotherapy, Computer-Assisted |
| D013812 | Therapeutics |
| D012074 | Remission Induction |
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|
|
| Chemotherapy | Drug | Induction chemotherapy: gemcitabine and cisplatin, Q3W, 3 cycles Concurrent chemotherapy: cisplatin, Q3W, 2-3 cycles |
|
|
| Immune checkpoint inhibitor | Biological | Cadonilimab: 10mg/kg, Q3W, 3 cycles |
|
|
| Low-dose radiotherapy | Radiation | Low-dose radiotherapy will be performed to study group, with the use of IMRT. |
|
| 3 years |
| Regional recurrence-free survival | From the date of randomization to regional recurrence or any death | 3 years |
| Distant metastasis-free survival | From the date of randomization to distant metastasis or any death | 3 years |
| Acute toxicities | Assessed with CTCAE v5.0 | From the start of treatment until 3 months post treatment |
| Late toxicities | Assessed with RTOG/EORTC | 3 years post treatment |
| Quality of life score | Assessed with EORTC-Quality of life questionnaire-C30 version 3.0 | Through study completion, an average of 3 years |
| The First Affiliated Hospital of Guangxi Medical University | Not yet recruiting | Nanning | Guangxi | China |
|
| Jiangxi Cancer Hospital | Not yet recruiting | Nanchang | Jiangxi | China |
|
| 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 |
| D006571 | Heterocyclic Compounds |
| D003841 | Deoxycytidine |
| D003562 | Cytidine |
| D011741 | Pyrimidine Nucleosides |
| D011743 | Pyrimidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D017606 | Chlorine Compounds |
| D007287 | Inorganic Chemicals |
| D017672 | Nitrogen Compounds |
| D017671 | Platinum Compounds |
| D045504 | Molecular Mechanisms of Pharmacological Action |
| D020228 | Pharmacologic Actions |
| D020164 | Chemical Actions and Uses |
| D000074322 | Antineoplastic Agents, Immunological |
| D000970 | Antineoplastic Agents |
| D045506 | Therapeutic Uses |