Docetaxel or Cisplatin radiosensitizer in Head and Neck cancer patients for curative or adjuvant chemoradiation
试验速览
- 阶段
- 3 期
- 状态
- 尚未招募
- 入组人数
- 600
- 试验地点
- 2
- 主要终点
- To compare 2 year OS between docetaxel based CTRT (D-CTRT) and cisplatin based
研究概览
简要总结
Importance of CTRT in head and neck cancers Locally advanced head and neck cancers have poor survivals. The 2 year , 5 year and 10 year overall survival post standard fractionation radiation are 45.6%, 29.3% and 18.3% respectively ( Beitler et al, RTOG 9003).1 The addition of concurrent chemotherapy to radiation leads to an improvement in survival. The 2 year and 5 year overall survival post concurrent chemoradiation are 55 % and 33.7 % in accordance with the MACH-NC analysis .2 The benefit of the addition of chemotherapy is consistent in all tumour locations, with hazard ratios between 0.87 and 0.88 .The benefit of chemotherapy on survival does not differ significantly postoperative radiotherapy (HR 0.79 [0.68–0.91]), or curative radiotherapy with conventional (HR 0.83 [0.78–0.88]) or altered fractionation (HR 0.73 [0.65–0.82]). In accordance with MACHNC
analysis there is no significant difference (p = 0.19) between mono-chemotherapy (HR 0.84) and polychemotherapy (HR 0.78). Among mono-chemotherapy group the impact of platinum was significantly higher than non platinum(p = 0.006). The hazard ratio for mono platinum was 0.74 [0.67;0.82] while it was 0.89 [0.82;0.96] for mono-non platinum therapy 2. Among platinum cisplatin HR of 5-year OS was 0.67 (95% CI, 0.49 to 0.92; P=0.01) , which showed a significant difference in favor of the cisplatin group.3 So cisplatin based chemoradiation is routinely used. In a study reported from TMH by Sarbani et al cisplatin based CTRT was associated with similar benefit. The locoregional control was better in the CTRT arm compared with the other 2 arms of Rt and accelerated RT (5 year locoregional control: RT group 32%, CTRT group 49%, and accelerated RT group 27%; p = .049; log-rank test). On comparison among the groups, the CTRT arm was significantly better than accelerated RT in terms of locoregional control (p = .01). The CRT arm showed a significantly better DFS compared with the other 2 arms (5-year DFS: RT group 25%, CRT group 39%, and accelerated RT group 20%; p = .03
研究设计
- 研究类型
- Interventional
- 分配方式
- Stratified randomization
- 盲法
- Open Label
入排标准
- 年龄范围
- 18.00 Year(s) 至 85.00 Year(s)（—）
- 性别
- All
入选标准
- •1.Participants must have a histologically confirmed stage III-IV squamous cell cancers of the head and neck region ( AJCC-UICC staging ,8th edition).
- •2.Participants must warrant CTRT must warrant at least one of the following a.Radical setting : Stage III-IV head and neck cancer b.Adjuvant setting : Stage III-IV head and neck cancer postoperative with one of the below mentioned feature on pathology specimen i.Extracapsular extension ii.Margin positive iii.Close margin ( cut margin 0.5 mm or below) 3.Participants must have malignancy arising from one of the following sites oral cavity, pharynx ( inclusive of oropharynx, hypopharynx) or larynx ( inclusive of supraglottis, glottis and subglottis) or CUP ( carcinoma unknown primary) with neck nodes 4.ECOG performance status ≤2 5.Participants must have normal organ and marrow function as defined below: a.Leukocytes≥3,000/mcL b.Platelets≥100,000/mcL c.Total bilirubin< 1.5 × institutional upper limit of normal d.AST(SGOT)/ALT(SGPT) ≤1.5 × institutional upper limit of normal e.Calculated Creatinine clearance > 50 ml/min.
排除标准
- •1.Participants who are receiving any other investigational agents.
- •2.Primary sites of malignancy major salivary gland or nasopharynx or skin 3.Patients with QTc prolongation defined as QTc interval greater than 480 ms in view of risk of sudden cardiac death associated with use of antiemetics.
- •4.History of allergic reactions attributed to compounds of similar chemical or biologic composition to any agents used in study.
- •5.Uncontrolled intercurrent illness including, but not limited to tuberculosis, diabetes, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, renal failure (on dialysis), active gastrointestinal bleeding, cerebrovascular accidents, inflammatory bowel disease, known hyperkalemia ( CTCAE version 4.02 grade 3 or above which is persistent over 1 week) or psychiatric illness/social situations that would limit compliance with study requirements.
- •6.Presence of grade 3 or above sensory hearing loss 7.Pregnant women and breastfeeding women are excluded from this study because docetaxel has the potential for teratogenic or abortifacient effects.
- •Because there is an unknown but potential risk for adverse events in nursing infants.
- •These potential risks may also apply to other agents used in this study.
- •8.HIV-positive, Active Hepatitis B and Active Hepatitis C seropositive patients are excluded from this study.
结局指标
主要结局
To compare 2 year OS between docetaxel based CTRT (D-CTRT) and cisplatin based
时间窗: To compare 2 year OS between docetaxel based CTRT (D-CTRT) and cisplatin based | CTRT(C-CTRT) Secondary objectives a. To compare 2 year PFS between docetaxel based CTRT (D-CTRT) and | cisplatin based CTRT(C-CTRT) b. To compare acute and late toxicity between docetaxel based CTRT (D-CTRT) | and cisplatin based CTRT(C-CTRT)
and cisplatin based CTRT(C-CTRT)
时间窗: To compare 2 year OS between docetaxel based CTRT (D-CTRT) and cisplatin based | CTRT(C-CTRT) Secondary objectives a. To compare 2 year PFS between docetaxel based CTRT (D-CTRT) and | cisplatin based CTRT(C-CTRT) b. To compare acute and late toxicity between docetaxel based CTRT (D-CTRT) | and cisplatin based CTRT(C-CTRT)
CTRT(C-CTRT) Secondary objectives a. To compare 2 year PFS between docetaxel based CTRT (D-CTRT) and
时间窗: To compare 2 year OS between docetaxel based CTRT (D-CTRT) and cisplatin based | CTRT(C-CTRT) Secondary objectives a. To compare 2 year PFS between docetaxel based CTRT (D-CTRT) and | cisplatin based CTRT(C-CTRT) b. To compare acute and late toxicity between docetaxel based CTRT (D-CTRT) | and cisplatin based CTRT(C-CTRT)
cisplatin based CTRT(C-CTRT) b. To compare acute and late toxicity between docetaxel based CTRT (D-CTRT)
时间窗: To compare 2 year OS between docetaxel based CTRT (D-CTRT) and cisplatin based | CTRT(C-CTRT) Secondary objectives a. To compare 2 year PFS between docetaxel based CTRT (D-CTRT) and | cisplatin based CTRT(C-CTRT) b. To compare acute and late toxicity between docetaxel based CTRT (D-CTRT) | and cisplatin based CTRT(C-CTRT)
次要结局
- a. To compare 2 year PFS between docetaxel based CTRT (D-CTRT) and cisplatin based CTRT(C-CTRT)(b. To compare acute and late toxicity between docetaxel based CTRT (D-CTRT) and cisplatin based CTRT(C-CTRT))