CTRI/2017/05/008700尚未招募2/3 期
DHANUSH : Docetaxel as radiosensitizer in Head And Neck cancer patients,Unsuitable for ciSplatin based cHemoradiation
试验速览
- 阶段
- 2/3 期
- 状态
- 尚未招募
- 入组人数
- 600
- 试验地点
- 1
- 主要终点
- 1.Overall survival
研究概览
简要总结
Chemoradiation (CTRT) with cisplatin is the standard of care in locally advanced head and neck cancers. However in clinical practice about about 10-20% of patients are unfit for cisplatin. At present these patients are treated with radical radiation or docetaxel based CTRT or RT ( radiation) with cetuximab on physician s discretion and logistic feasibility. Recent meta analysis have suggested that taxane based chemoradiation might be superior to only RT in head and neck cancers. However whether docetaxel based chemoradiation can provide similar benefit in patients who are unfit for cisplatin as provided by cisplatin based CTRT over radiation is unknown.
It is Phase 2 going to Phase 3 randomized, parallel, open label, superiority , explanatory design.
Patients will be randomized on Arm A and Arm B.
Arm A : Radical radiation ( conventional or altered fractionation)
Arm B : Radical radiation ( conventional or altered fractionation) + weekly docetaxel ( 15 mg/m2 for maximum of 7 cycles)
Outcomes will be 2years OS,2 Years PFS,Toxicity and Trial Outcome Index.
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 90.00 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.
- •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.Unsuitable for cisplatin due to at least anyone of the following reason a.Performance status ECOG (Eastern Cooperative Oncology Group) score of grade 2 b.Organ dysfunction of grade 2 or higher based on the NCI CTC (National Cancer Institute Common Toxicity Criteria) version 4.0 , such as hearing loss and tinnitus and neurologic disorders c.Hypersensitivity to Cisplatin d.Calculated creatinine clearance (CCR) value of <50 ml/min e.Borderline organ function or comorbidities precluding use of cisplatin f.Weight loss : > 10% of baseline body weight in preceding 6 months g.Nutritional status : Malnourished status as defined by BMI 16 KG/m2 h.Concomitant use of nephrotoxic drugs required for concurrent medical condition 5.Age : Any age above 18 years.
- •No maximum age.
- •6.ECOG performance status ≤2 7.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 > 30 ml/min 8.The effects of docetaxel chemotherapy on the developing human fetus are teratogenic.
- •Hence women of childbearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry and for the duration of study participation.
- •Should a woman become pregnant or suspect she is pregnant while she or her partner is participating in this study, she should inform her treating physician immediately.
- •Men treated or enrolled on this protocol must also agree to use adequate contraception prior to the study, for the duration of study participation, and 6 months after completion of protocol.
- •9.Both men and women of all races and ethnic groups are eligible for this trial.
- •10.Willing and able to comply with all study requirements 11.Ability to understand and the willingness to sign a written informed consent document.
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.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.
- •7.HIV-positive, Active Hepatitis B and Active Hepatitis C seropositive patients are excluded from this study.
结局指标
主要结局
1.Overall survival
时间窗: 1. 2 Years
次要结局
- 1.Disease Free survival(2.Quality of life)
研究者
研究点 (1)
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