About this trial
This is a multi-center, multidisciplinary, open-label, randomized controlled prospective clinical study.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Able to understand and willing to sign a written informed consent document.
Age ≥ 18 and ≤ 75 years.
Male or female.
Karnofsky physical status (KPS): ≥ 80
Disqualifiers
Distant metastatic disease
Have a history of other cancers or coinstantaneous second primary tumor
Previous treatment for the primary tumor, including radiotherapy, surgery except biopsy operation, chemotherapy, immunotherapy and biological targeted therapy.
Patients who have participated in other clinical trials within 1 month before the test.
Trial design
Parallel
Treatments tested in this trial
Docetaxel
Drug60 mg/m2 i.v. day 1
Cisplatin
Drug60 mg/m2 i.v. day 1-3
Capecitabine
Drug750 mg/m2 po bid day 1-14
Concomitant chemoradiotherapy
RadiationRadiotherapy: using intensity-modulated radiation therapy (IMRT) Gross tumor volume (GTV) for primary tumor: 66-70 Gy in total, 2.0\~2.2 Gy per day, 5 days per week Clinical target volume (CTV) for lesions closely related to the primary lesion and metastatic lymph nodes: 65\~70 Gy in total, 1.7\~2.0 Gy per day, 5 days per week Prophylactic irradiation for sites of suspected subclinical spread: 50\~60 Gy in total, 1.7\~2.0 Gy per day, 5 days per week Concurrent chemotherapy: cisplatin 80 mg/m2 on days 1-3 every 3 weeks.
Surgery
Procedure/SurgeryNeck dissection and primary tumor resection
Treatment groups
Trial outcomes
Primary outcomes
Progression-free survival rate
The proportion of patients with disease progress or death due to any reasons.
Secondary outcomes
Overall survival rate
The proportion of dead patients due to any reasons.
Local control
The proportion of patients with local recurrence.
Regional control
The proportion of patients with regional recurrence.
Metastasis-free survival
The proportion of patients with distant metastasis.
Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Eye & ENT Hospital of Fudan University
Lead sponsor
Shandong Provincial Hospital
Collaborator
Harbin Medical University Third Affiliated Hospital
Collaborator