Concurrent Chemoradiotherapy in Locally Advanced Squamous Cell Carcinoma of the Head and Neck Versus Concomitant Cetuximab With Radiotherapy After Neoadjuvant Chemotherapy: a Randomized, Opened, Multicenter Phase II Trial
Overview
- Phase
- Phase 2
- Intervention
- Cetuximab
- Conditions
- Carcinoma, Squamous Cell of Head and Neck
- Sponsor
- Daping Hospital and the Research Institute of Surgery of the Third Military Medical University
- Enrollment
- 60
- Primary Endpoint
- Progression-free survival
- Last Updated
- 10 years ago
Overview
Brief Summary
Verify the effect and the incidence of oral mucositis of concurrent chemoradiotherapy in locally advanced squamous cell carcinoma of the head and neck versus concomitant cetuximab with radiotherapy after neoadjuvant chemotherapy.
The predictive effect of Apurinic/apyrimidinic endonuclease 1(APE1)/ Ref-1 protein and Apurinic/apyrimidinic endonuclease 1(APE1)/Ref-1 antibody on oral mucositis.
Investigators
Zhen-zhou Yang
Director
Daping Hospital and the Research Institute of Surgery of the Third Military Medical University
Eligibility Criteria
Inclusion Criteria
- •Histologically or cytologically confirmed first diagnosis of locally advanced squamous cell carcinoma of the head and neck
- •Imaging (MRI, CT, bone scan) stage Ⅲ、Ⅳa (T1-2N2M0、T3N0-2M0、T4N0-2M0) (2010AJCC staging criteria)
- •18 years of age or older
- •Presence of at least 1 measurable lesion according to RECIST version1.1
- •DON'T accept surgery, chemotherapy or irradiation before trial entry
- •Eastern Cooperative Oncology Group(ECOG) 0 or 1
- •Expected survival period over 6months
- •Before RT randomization, bone marrow and liver and kidney function in patients with meet the following criteria:
- •Hemoglobin(HB) ≥ 100g/L, neutrophil ≥ 2.0 × 109/L and platelet ≥ 100 × 109/L
- •Total bilirubin ≤ 1.5 times the upper limit of normal, aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤ 1.5 times the upper limit of normal;
Exclusion Criteria
- •Patients accepted chemotherapy、radiotherapy or surgery;
- •Distant metastasis before trail entry
- •Female subjects who are pregnant or breast feeding;
- •oral mucositis or oral mucositis has repeatedly made (1 times / month or more)before Chemotherapy or radiotherapy ;
- •With teeth periodontitis;
- •Any investigational medication within 30 days before trial entry;
- •Elderly patients with dry stomatitis;
- •Any unstable system diseases: including active infection, uncontrolled hypertension, unstable angina pectoris, within the last 3 months of the onset of angina, congestive heart failure, the group in June before the myocardial infarction, need serious mental disorder drug treatment, liver, kidney or metabolic diseases; mental / spiritual diseases such as Alzheimer's disease;
- •Total bilirubin \> 1.5 times the upper limit of normal, aspartate aminotransferase (AST) and alanine aminotransferase (ALT) \> 2.5 times the upper limit of normal;
- •On gastrointestinal physiology is not perfect, or absorb the obstacle syndrome, or unable to tolerate oral medication, or active peptic ulcer；
Arms & Interventions
RT concurrent with cetuximab
Selected 60 patients with locally advanced squamous cell carcinoma of the head and neck. They will be randomized to concurrent chemoradiotherapy versus concomitant cetuximab with radiotherapy after neoadjuvant chemotherapy.To observe the curative effect of the treatment of the cetuximab
Intervention: Cetuximab
RT concurrent with cetuximab
Selected 60 patients with locally advanced squamous cell carcinoma of the head and neck. They will be randomized to concurrent chemoradiotherapy versus concomitant cetuximab with radiotherapy after neoadjuvant chemotherapy.To observe the curative effect of the treatment of the cetuximab
Intervention: radiation
RT concurrent with TP
Selected 60 patients with locally advanced squamous cell carcinoma of the head and neck. They will be randomized to concurrent chemoradiotherapy versus concomitant cetuximab with radiotherapy after neoadjuvant chemotherapy. To observe the curative effect of concurrent radiotherapy and chemotherapy
Intervention: radiation
RT concurrent with TP
Selected 60 patients with locally advanced squamous cell carcinoma of the head and neck. They will be randomized to concurrent chemoradiotherapy versus concomitant cetuximab with radiotherapy after neoadjuvant chemotherapy. To observe the curative effect of concurrent radiotherapy and chemotherapy
Intervention: Docetaxel
RT concurrent with TP
Selected 60 patients with locally advanced squamous cell carcinoma of the head and neck. They will be randomized to concurrent chemoradiotherapy versus concomitant cetuximab with radiotherapy after neoadjuvant chemotherapy. To observe the curative effect of concurrent radiotherapy and chemotherapy
Intervention: Cisplatin
Outcomes
Primary Outcomes
Progression-free survival
Time Frame: 13 months
incidence of oral mucositis
Time Frame: 3 months
Secondary Outcomes
- Overall survival(5 years)
- Overall response rate after induction chemotherapy(1 month)