A Phase II Study of Tongue Conservation Surgery for Advanced Oral Tongue Cancer: Induction Chemotherapy, Followed by Tongue Conservation Surgery and Postoperative Chemoradoitherapy
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 入组人数
- 23
- 主要终点
- Objective response rate
研究概览
简要总结
This is an open-label, non-comparative phase II clinical trial to assess efficacy and safety of tongue conservation treatment with sequential induction chemotherapy, tongue conservation surgery and postoperative concurrent chemoradiotherapy (CCRT) in patients with advanced oral tongue cancer.
详细描述
Surgical resection remains the most important component of standard treatment for oral tongue cancer, but may lead to profound functional impacts not effectively compensated by reconstruction surgery. The volume of tongue resection remains one key factor for the post-treatment deterioration of the functional outcomes and quality of life in large oral tongue cancer. Primary chemoradiotherapy without surgical resection has not been accepted for oral tongue cancer because of the concerns about possible poorer response and sequelae. Breast conservation treatment, by the sequential use of induction chemotherapy (ICT), limited surgical resection and chemoradiotherapy, has become a standard treatment for human breast cancer of various stages. However, similar tongue conservation treatment for advanced oral tongue cancer has not been studied in trials. Based on these data, it will be reasonable, in locally advanced (> 3 cm) resectable oral tongue cancers, to test whether ICT followed by tongue conservation surgery and postoperative CCRT can safely enhance the possibility of tongue conservation with improved post-treatment functions.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 20 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with histological proof of squamous cell carcinoma of oral tongue
- •b. cT2-4, N0-2,M0, by clinical or radiographic examinations
- •Either mandibulotomy, mandibulectomy or flap reconstruction is required by standard surgical planning
- •Eastern Cooperative Oncology Group (ECOG) performance status of 0-1
- •Between 20 and 70 years of age
- •Adequate hematopoietic function as defined below:
- •Hemoglobin >= 10g/dl Absolute neutrophil count (ANC) >= 1,500/µL Platelets >= 100,000/µL
- •Adequate organ function as defined below:
- •Total bilirubin, alanine aminotransferase (ALT), aspartate aminotransferase (AST), creatinine <= 1.5 x upper limit of normal Creatinine clearance > 50 ml/min
- •Signed study-specific consent form prior to study entry
排除标准
- •Patients received gross oral tongue tumor resection before evaluation
- •Primary subsites other than oral tongue
- •Histologic diagnosis other than squamous cell carcinoma
- •Patient with synchronous primary cancers (within 6 months)
- •Clinical or radiographic findings as below:
- •T1 tumors Gross invasion to mandible, tonsil or >1/3 base of tongue N3 disease or distant metastasis (M1)
- •Prior head and neck chemotherapy or radiotherapy
- •Prior esophageal cancer history
- •Active cardiac disease defined as: unstable angina, uncontrolled arrhythmia, myocardial infarction within 6 months.
- •Severe chronic obstructive pulmonary disease (COPD) requiring ≥ 3 hospitalizations over the past year
- •Mental status not fit for clinical trial.
- •Pregnant or breast feeding women, or women of child-bearing potential unless using a reliable and appropriate contraceptive method.
研究组 & 干预措施
Induction chemotherapy
Induction chemotherapy will be given every 21 days, with the DCU regimen, followed by tongue conservation surgery, and postoperative CCRT as indicated.
干预措施: Induction chemotherapy (Drug)
Induction chemotherapy
Induction chemotherapy will be given every 21 days, with the DCU regimen, followed by tongue conservation surgery, and postoperative CCRT as indicated.
干预措施: Tongue conservation surgery (Procedure)
Induction chemotherapy
Induction chemotherapy will be given every 21 days, with the DCU regimen, followed by tongue conservation surgery, and postoperative CCRT as indicated.
干预措施: postoperative CCRT (Radiation)
结局指标
主要结局
Objective response rate
时间窗: 2 weeks after completion of the last cycle of induction chemotherapy
Response to induction chemotherapy
次要结局
- Pathological response of induction chemotherapy(2 weeks after surgery)
- Longitudinal quality of life (QOL)(Date of recruitment, 2 weeks after ICT completion, 3 months after treatement copletion, 1 year after treatment completion)
- Oncologic results(5 years after treatment completion)
- Tongue conservation surgery feasibility rates(the date of surgery)