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The main objective of this trial was to determine the value of concurrent chemoradiotherapy for Intermediate-risk head and neck squamous cell carcinoma
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 2 courses of cisplatin chemoradiotherapy arm | Experimental | Patients will receive intensity modulated radiotherapy (total dose: > 66 Gy, split dose: 2-2.2 Gy/ time, once a day, 5 times a week) plus concurrent Cisplatin chemotherapy (100 mg/m2 intravenous injection,once every 3 weeks, twice in total, on days 1 and 22). |
|
| Postoperative adjuvant radiotherapy alone | No Intervention | Patients will receive intensity modulated radiotherapy (total dose: > 66 Gy, split dose: 2-2.2 Gy/ time, once a day, 5 times a week) |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Cisplatin | Drug | Concurrent Cisplatin chemotherapy (100 mg/m2 intravenous injection,once every 3 weeks, twice in total, on days 1 and 22) will be given plus intensity modulated radiotherapy |
| Measure | Description | Time Frame |
|---|---|---|
| Failure-free survival (FFS) | calculated from enrolment to the date of locoregional recurrence,distant metastasis,or death from any cause, whichever occurred first. | 3 years |
| Measure | Description | Time Frame |
|---|---|---|
| Overall survival (OS) | calculated from enrolment to the date of death from any cause. | 3 years |
| Distant metastasis-free survival(DMFS) | calculated from enrolment to the date of first distant metastasis. |
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Inclusion Criteria:
A. The pathological type is head and neck squamous cell carcinoma
B. Radical surgery has been performed, and there are intermediary-risk factors (pT3/pT4, pN2/pN3, positive lymph nodes in the cervical IV/V region of oral cancer, nerve invasion, and vascular invasion).
C. No evidence of distant metastasis (M0).
D. Functional status: Karnofsky scale (KPS) > 70.
E. Normal bone marrow function:
G. Normal liver function:
H. Normal renal function: creatinine clearance > 60 ml/min.
I. Patients must be informed of the basic contents of this study and sign informed consent.
Exclusion Criteria:
A. Age >70 years or <18 years.
B. Treatment is palliative.
C. Previous chemotherapy (except induction chemotherapy prior to surgery).
D. Previous radiation therapy.
E. Women who are pregnant or breastfeeding
F. Previous history of malignant tumor.
G. With other serious medical conditions that may pose a greater risk or affect compliance with the test. Examples include:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Lei Chen, M.D | Contact | +862013570051477 | chenlei@sysucc.org.cn |
| Name | Affiliation | Role |
|---|---|---|
| Lei Chen Principal Investigator, M.D | Sun Yat-sen University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Sun Yat-sen University Cancer Center | Recruiting | Guangzhou | Guangdong | 523000 | China |
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| 3 years |
| locoregional recurrence-free survival (LRRFS) | calculated from enrolment to the date of locoregional persistence or 1st locoregional recurrence. | 3 years |
| Quality of life (QoL) | The change of QoL from randomization to the start of radiotherapy,the end of radiotherapy,13-16 weeks after radiotherapy,2 years and 3 years after randomization. The EORTC QoL questionnaire-C30(EORTC quality of life questionnaire-C30#version 3.0 will be used. This questionnaire comprises 30 questions,24 of which are aggregated into nine multi- question scales,that is,five functioning scales (e.g.,physical),three symptom scales (e.g.,fatigue)and one global health status scale. The remaining six single-question (e.g.,dyspnoea)scales assess symptoms. These 15 scales will be scored according to the official Scoring Manual. | 3 years |
| Sun Yat-sen University Cancer Center | Recruiting | Guangzhou | Guangdong | 523000 | China |
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| Affiliated Hospital of Guilin Medical College | Recruiting | Guilin | Guangxi | China |
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| Hainan General Hospital | Recruiting | Sanya | Hainan | China |
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| Hunan Cancer Hospital | Recruiting | Changsha | Hunan | China |
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| Xiangya Hospital, Central South University | Recruiting | Changsha | Hunan | China |
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| Jiangsu Cancer Hospital | Recruiting | Nanjing | Jiangsu | China |
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| ID | Term |
|---|---|
| D002945 | Cisplatin |
| ID | Term |
|---|---|
| D017606 | Chlorine Compounds |
| D007287 | Inorganic Chemicals |
| D017672 | Nitrogen Compounds |
| D017671 | Platinum Compounds |
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