Induction Chemotherapy (IC) With Paclitaxel and Cisplatin (PC) Followed by Concomitant Chemoradiotherapy (CCRT) in Patient With Advanced Squamous Carcinoma of the Head and Neck (SSCHN).
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Tumor response rate
研究概览
简要总结
Over the last 30 years, induction chemotherapy (IC) has become important for the management of patients with locally advanced HNSCC (LAHNSCC), particularly since the introduction of taxanes. The results reported in the TAX 323 and TAX 324 trials indicate that the TPF regimen (docetaxel, cisplatin and 5-fluorouracil) improves overall survival comparing with the PF regimen (cisplatin and 5-fluorouracil), and the TPF regimen is globally the most accepted induction regimen for the treatment of LAHNSCC.
However, the TPF regimen has been associated with high toxicity rates, and patients frequently decline cisplatin during concurrent radiotherapy and require the use of infusion pumps and a central venous catheter.
Extensive efforts are ongoing to identify alternative schemes that are less toxic than the TPF regimen but are as effective for LAHNSCC and safely allow the use of definitive concurrent treatment based on cisplatin and radiotherapy.
详细描述
This non-randomized phase II trial evaluated the safety, feasibility and response rates of concurrent therapy (cisplatin and radiotherapy) after three cycles of an IC regimen based on the combination of cisplatin plus paclitaxel without 5-fluorouracil (5FU) (thereby avoiding infusion pumps and a central venous catheter) in LAHNSCC patients with a high tumor burden.
The patients were stratified by tumor subsite (oropharynx and hypopharynx/larynx) and by tumor resectable status (resectable or irresectable advanced squamous cell).
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
- 18 Years 至 76 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Histologically confirmed locally advanced squamous cell carcinoma of head and neck (stage III and IV) eligible to chemoradiotherapy.
- •Presence of measurable disease
- •≥ 18 year
- •ECOG performance status: 0-2
- •Adequate bone marrow functions evidenced by: absolute neutrophil count ≥ 1.5 x 109/L; platelet count ≥ 100 x 109/L and hemoglobin ≥ 90 g/L
- •Adequate renal function.
- •Adequate hepatic function.
- •Patients or their legal representatives must be able to read, understand and provide written informed consent to participate in the study.
排除标准
- •Any previous chemotherapy or radiotherapy
- •Patients who have known hypersensitivity to paclitaxel or cisplatin
- •Patients who are receiving concurrent investigational, biological or immune therapies
- •Concomitant administration of high doses of systemic corticosteroids
- •Known HIV or Hepatitis B or C (active, previously treated or both; testing is not required)
- •Uncontrolled CNS disease (e.g., seizures not controlled with standard medical therapy)
- •Clinically significant cardiovascular disease.
研究组 & 干预措施
Induction TP chemotherapy followed by CRT
paclitaxel 175mg/m2 as a 3-h infusion on Day 1, and cisplatin 80mg/m2 as a 2-h infusion on Day 1 three weekly followed by concurrent chemoradiotherapy based on cisplatin. All patient were given adequate hydration and antiemetics. All patients received supportive care during radiotherapy, including dietary measures, local antiseptics and laser therapy as preventive and curative support for oral mucositis.
干预措施: Induction TP chemotherapy (Drug)
Induction TP chemotherapy followed by CRT
paclitaxel 175mg/m2 as a 3-h infusion on Day 1, and cisplatin 80mg/m2 as a 2-h infusion on Day 1 three weekly followed by concurrent chemoradiotherapy based on cisplatin. All patient were given adequate hydration and antiemetics. All patients received supportive care during radiotherapy, including dietary measures, local antiseptics and laser therapy as preventive and curative support for oral mucositis.
干预措施: Chemoradiotherapy (CRT) (Radiation)
结局指标
主要结局
Tumor response rate
时间窗: At baseline, 2 weeks after the third cycle of IC and 6-8 weeks after the end of radiotherapy
Tumor response was assessed after induction chemotherapy (just before chemoradiotherapy) and 6-8 weeks after completion of chemoradiotherapy. Evaluation of tumor response was by clinical examination, nasoendoscopy, and CT or MRI imaging of the primary site and the neck (RECIST criteria 1.1).
次要结局
- Overall survival(3 years)
- Quality of life (EORTC QLQ-C30)(2 years)
- Adverse Events rate(After every cycle of IC, after every cycle of concurrent chemetherapy and up to 8 weeks after the end of radiotherapy)
- Progression-free survival.(3 years)
研究者
Luciano de Souza Viana
MD, PhD
Barretos Cancer Hospital