CTRI/2012/07/002783已完成2/3 期
A Multicenter, Phase II/III Study to Assess Radiation Induced Mucositis in Subjects with Locally Advanced Squamous Cell Carcinoma of the Head and Neck Administered Cisplatin and Radiation with or without P276-00
Piramal Healthcare Limited17 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2012年11月7日最近更新:
试验速览
- 阶段
- 2/3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 60
- 试验地点
- 17
- 主要终点
- incidence of severe (WHO Grade ≥ 3) Radiation Induced Mucositis (RIM)
研究概览
简要总结
A Multicenter, Phase II/III Study to Assess Radiation Induced Mucositis in Subjects with Locally Advanced Squamous Cell Carcinoma of the Head and Neck Administered Cisplatin and Radiation with or without P276-00
研究设计
- 研究类型
- Interventional
- 分配方式
- Permuted block randomization, fixed
- 盲法
- Outcome Assessor Blinded
入排标准
- 年龄范围
- 18.00 Year(s) 至 85.00 Year(s)（—）
- 性别
- All
入选标准
- •Able to understand and willing to give an informed consent for the study.
- •Pathologically (histologically or cytologically) confirmed (from primary tumor and/or lymph nodes), non-metastatic diagnosis of squamous cell carcinoma of the oral cavity, oropharynx, hypopharynx, or larynx eligible for treatment with concomitant chemoradiation as first-line treatment; subjects with a history of surgical management are not eligible
- •Have a plan to receive a continuous course of radiation (3DRT or IMRT) as single daily fractions of 2.0 Gy, with a cumulative radiation dose between 66 and 70 Gy. Planned radiation treatment fields must include at least 2 oral sites (maxillary or mandibular labial mucosa, right or left buccal mucosa, right or left floor of the mouth, ventral tongue, right or left lateral tongue, or soft palate), with each site receiving ≥ 50 Gy
- •Have a plan to receive a standard cisplatin regimen administered weekly (30 to 40 mg/m2)
- •Males or females aged 18 years or older
- •Pre-treatment dental procedures must be completed with recovery and the prophylactic insertion of gastric feeding tubes (if planned) prior to entry into the study
- •Adequate bone marrow function measured within two weeks prior to enrollment based upon CBC/differential, defined as follows: a) Absolute neutrophil count (ANC) ≥ 1,500 cells/mm3 b) Platelets ≥ 100,000 cells/mm3 c) Hemoglobin (Hb) ≥ 8.0 g/dl (Note: The use of transfusion or other intervention to achieve Hb ≥ 8.0 g/dl prior to the start of RT is acceptable)
- •Adequate hepatic function measured within two weeks prior to enrollment defined as follows: a) Bilirubin ≤ 1.5 mg/dl b) AST ≤ 2 times ULN c) ALT ≤ 2 times ULN
- •Adequate renal function measured within two weeks prior to enrollment and defined as follows a) Serum creatinine ≤ 1.5 mg/dl b) Creatinine clearance (CC) ≥ 60 ml/min determined by 24-hour urine collection or estimated by the Cockcroft-Gault formula:
- •Have a negative serum pregnancy test for women of childbearing potential at time of screening and negative urine pregnancy test within 72 hrs prior to first dose of study drug
- •Willing and able to complete the daily diary questionnaire either by themselves or with assistance.
排除标准
- •Tumor of the lips, sinuses, salivary glands, nasopharynx, or unknown primary tumor
- •Metastatic disease (M1) Stage IVC as per the AJCC, 7th edition
- •Prior radiation to the head and neck
- •Have undergone induction CT
- •History of malignant tumors other than HNC (except non-melanoma skin cancer) unless disease free for a minimum of 3 years
- •Severe comorbidity, defined as: a) Symptomatic and/or uncontrolled cardiac disease, New York Heart Association (NYHA) Classification III or IV b) Acute myocardial infarction within the last 6 months c) Acute bacterial or fungal infection requiring systemic antibiotics at the time of enrollment d) Subjects known to be seropositive for human immunodeficiency virus (HIV) or subjects with Acquired Immune Deficiency Syndrome (AIDS), known current acute or chronic Hepatitis B, known Hepatitis C (antigen positive), or hepatic cirrhosis e) Subjects with active tuberculosis f) Collagen vascular disease, such as scleroderma, as this is thought to predispose subjects to increased risk for radiation-associated toxicities
- •Have used any other investigational drug therapy within 1 month prior to Day 1 of study drug administration or non-recovery (to Grade ï‚£ 1) from adverse effects of the investigational agent received prior to this period
- •Prior allergic reaction to any of the agents administered during the course of treatment
- •Have QTcF 450 msec at screening
- •Have any other life-threatening illness, significant organ system dysfunction, or clinically significant laboratory abnormality, which in the opinion of the Investigator, would either compromise the patient’s safety, interfere with evaluation of the study drug, or make the subject unsuitable for the study or unable to comply with follow-up visits.
- •Sexually active female subjects of childbearing potential and male subjects with partner of child-bearing potential unwilling to use adequate contraception from the time of signing informed consent document, throughout the duration of the study and for atleast 3 months after end of study treatment or following withdrawal from the study.
结局指标
主要结局
incidence of severe (WHO Grade ≥ 3) Radiation Induced Mucositis (RIM)
时间窗: Mucositis assessment will be performed by treatment-blinded, trained evaluators twice weekly (at least 48 hours apart) within each 5 day RT treatment week during the radiation period, including treatment breaks. Twice weekly assessments will continue following the end of RT until WHO Grade ≤ 2 or until 8 weeks after Last Day of RT (Week 15 from start of study treatment), whichever occurs first.
次要结局
- Time to onset of severe RIM (WHO Grade ≥ 3)(Mucositis assessment will be performed by treatment-blinded, trained evaluators twice weekly (at least 48 hours apart) within each 5 day RT treatment week during the radiation period, including treatment breaks. Twice weekly assessments will continue following the end of RT until WHO Grade ≤ 2 or until 8 weeks after Last Day of RT (Week 15 from start of study treatment), whichever occurs first.)
- Duration of severe RIM (WHO Grade ≥ 3)(Mucositis assessment will be performed by treatment-blinded, trained evaluators twice weekly (at least 48 hours apart) within each 5 day RT treatment week during the radiation period, including treatment breaks. Twice weekly assessments will continue following the end of RT until WHO Grade ≤ 2 or until 8 weeks after Last Day of RT (Week 15 from start of study treatment), whichever occurs first.)
研究者
研究点 (17)
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