NCT03815903招募中3 期
A Phase 3, Randomized, Open-label Clinical Trial of Induction Chemotherapy Followed by Chemoradiotherapy Versus Chemoradiotherapy in Patients With Locally Advanced Head and Neck Squamous Cell Carcinoma
Barretos Cancer Hospital1 个研究点 分布在 1 个国家目标入组 434 人开始时间: 2018年12月19日最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 发起方
- 入组人数
- 434
- 试验地点
- 1
- 主要终点
- 3-years overall survival
研究概览
简要总结
The benefit of induction chemotherapy followed by chemoradiotherapy for locally advanced head and neck squamous cell carcinoma is unknown. The present study is investigating if this therapeutic strategy improve overall survival.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Confirmed histological diagnosis of squamous cell carcinoma or undifferentiated carcinoma of the oropharynx, hypopharynx or larynx;
- •Locally advanced stage (stage IVa / b - AJCC 8th edition), classified as resectable ** or unresectable and candidate for treatment based on radiotherapy and chemotherapy;
- •Locally advanced stage (stage III - AJCC 8th edition), classified as resectable or unresectable, positive p16 and candidate for treatment based on radiotherapy and chemotherapy;
- •It will be allowed to include a patient with cervical lymphadenectomy if the primary lesion is measurable;
- •Presence of measurable disease according to RECIST 1.1 criteria;
- •ECOG performance status of 0-1;
- •≥ 18 years;
- •Adequate marrow reserve indicated by:
- •Absolute neutrophil count (ANC) ≥ 1500 / mm³ or Platelets> 100,000 / mm³
- •Hemoglobin ≥ 9 g / dL - red blood cell transfusion will be allowed in the screening period if necessary
- •Adequate renal and hepatic function:
- •Serum bilirubin ≤ 1.5 times the upper limit of normal the TGO and TGP ≤ 3 upper limit of normal. If hepatic metastasis ≤ 5 upper limit of normal
- •Serum creatinine ≤ 1.5 mg / dL and creatinine clearance ≥ 60 mL / min calculated by Cockcroft-Gault.
排除标准
- •Patient submitted to curative resection of the primary site and / or metastatic site. NOTE: Patients submitted to cervical lymphadenectomy without surgery to the primary tumor are eligible;
- •Radiation therapy or previous chemotherapy for head / neck tumor;
- •Patients with occult primary tumor;
- •T4 from any site, resectable, with invasion of cartilage or jaw;
- •History of BMT or stem cell therapy;
- •Synchronous tumor or previous history of neoplasia, except for in situ carcinoma of the cervix, basal cell carcinoma or epidermoid carcinoma. Patients with previous history of cancer already treated and without evidence of disease for more than 3 years may participate in the study;
- •Prophylactic use of G-CSF or GM-CSF two weeks prior to the study;
- •Clinically significant heart disease: unstable angina or myocardial infarction 6 months prior to study entry Symptomatic ventricular arrhythmia the ICC classified as NYHA ≥ II • Uncontrolled hypercalcemia;
- •Uncontrolled infection;
- •Any other comorbidity that the investigator's judgment is inappropriate for the study;
- •Peripheral neuropathy> grade 2;
- •Hearing loss> grade 2;
- •Known positive serology for hepatitis B, hepatitis C or HIV
- •Use of antiretrovirals;
研究组 & 干预措施
A - induction chemotherapy
Active Comparator
干预措施: Induction chemotherapy (Drug)
A - induction chemotherapy
Active Comparator
干预措施: Chemoradiotherapy (Combination Product)
B - chemoradiotherapy
Experimental
干预措施: Chemoradiotherapy (Combination Product)
结局指标
主要结局
3-years overall survival
时间窗: From date of randomization until 3 years
次要结局
- Adverse Events Rates(At the end of cycle 1, cycle 2 and cycle 3 (each cycle is 21 days).)
- Progression free survival(From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 100 months)
- Systemic relapse free survival(From date of randomization until the date of first systemic relapse or date of death from any cause, whichever came first, assessed up to 100 months)
- Overall survival(From date of randomization until the date of death from any cause, whichever came first, assessed up to 100 months)
- Overall response rate(At the end of Cycle 3 of IC (each cycle is 21 days) and 8 weeks after the end of radiotherapy, through study completion, an average of 6 months)
- 1-year functional organ preservation rate(From date of randomization until 1 year after)
- Quality of Life (EORTC Quality of Life Questionnare - C30 version 3.0)(From date of randomization until 5 years)
- Overall response rate to induction chemotherapy(At the end of Cycle 3 (each cycle is 21 days))
研究者
研究点 (1)
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