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The aim of this study is to develop an adaptive radiation therapy plan for locally advanced head and neck squamous cell carcinoma receiving induction therapy containing immunotherapy and chemotherapy. The therapy plan is based on clinical remission, in order to reduce treatment-related toxic side effects without sacrificing clinical efficacy and improve the quality of life of patients.
Induction chemotherapy combined with immunotherapy has shown promising efficacy in locally advanced head and neck cancers. However, the appropriate dose and range of the following radical radiotherapy treatment remains unknown. Eligibility patients were assigned to three arms depending on the degree of clinical remission: clinical complete response (radiotherapy 60Gy + concurrent chemotherapy + immunotherapy maintenance), deep partial response (radiotherapy 66Gy + concurrent chemotherapy + immunotherapy maintenance, non-deep partial response (radiotherapy 70Gy + concurrent chemotherapy + immunotherapy maintenance). Progression-free survival, overall survival, and treatment-related toxicity would be calculated to evaluate the efficacy of treatments.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| clinical complete response | Experimental | radiotherapy 60Gy + concurrent chemotherapy + immunotherapy maintenance |
|
| deep partial response | Experimental | radiotherapy 66Gy + concurrent chemotherapy + immunotherapy maintenance |
|
| non-deep partial response | Experimental | radiotherapy 70Gy+ concurrent chemotherapy + immunotherapy maintenance |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| radical radiotherapy (60Gy) | Radiation | concurrent chemoradiotherapy (60Gy) after induction therapy |
|
| Measure | Description | Time Frame |
|---|---|---|
| Progression-free survival | defined as the time from random assignment to documented local or regional relapse, distant metastasis, or death from any cause, whichever occurred first after 2 years of treatment | 2 years |
| Measure | Description | Time Frame |
|---|---|---|
| Overall survival | defined as the time from random assignment to death from any cause or censored at the date of last follow-up | 2 years |
| Deep partial response | Defined as maximum tumor diameter retreat ≥ 50% |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Yang Meng | Contact | 13359595417 | YangMeng@pumc.edu.cn |
| Name | Affiliation | Role |
|---|---|---|
| Junlin Yi, Doctor | National Cancer Center/National Clinical Research Center for Cancer/Cancer Hospital, CAMS & PUMC | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| National Cancer Center/National Clinical Research Center for Cancer/Cancer Hospital, CAMS & PUMC | Recruiting | Beijing | China |
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| radical radiotherapy (66Gy) | Radiation | concurrent chemoradiotherapy (66Gy) after induction therapy |
|
| radical radiotherapy (70Gy) | Radiation | concurrent chemoradiotherapy (70Gy) after induction therapy |
|
| anti-PD-1 or PD-L1 antibody | Combination Product | immunotherapy maintenance with anti-PD-1 or PDL1antibody every three weeks for 1 year after radiotherapy |
|
| 2 years |
| Local-Regional failure survival | defined as the time from random assignment to documented local or regional relapse, whichever occurred first after 2 years of treatment | 2 years |
| Toxicity Adverse events | Analysis of acute and late adverse events (AEs) are evaluated. Numbers of patients of treatment-related adverse events (acute toxicity) and late radiation toxicities were assessed by NCI-CTCAE v5.0 | 2 years |
| ID | Term |
|---|---|
| D006258 | Head and Neck Neoplasms |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
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