A Randomized Multicenter Phase II Study Using HPPH With PDT Versus Standard of Care Surgery for Patients With T1/T2 Squamous Cell Carcinoma of the Oral Cavity
试验速览
- 阶段
- 2 期
- 状态
- 撤回
- 试验地点
- 1
- 主要终点
- Objective tumor response assessed according to Response Evaluation Criteria in Solid Tumors version 1.1
研究概览
简要总结
This randomized phase II trial studies how well photodynamic therapy with HPPH works in treating patients with squamous cell carcinoma of the oral cavity. Photodynamic therapy uses HPPH that becomes active when it is exposed to a certain kind of light. When the drug is active, cancer cells are killed. This may be effective against squamous cell carcinoma of the oral cavity.
详细描述
PRIMARY OBJECTIVES:
I. To test the non-inferiority of photodynamic therapy (PDT) to standard of care surgery.
SECONDARY OBJECTIVES:
I. To determine improvement in quality of life (QoL) using the University of Washington Quality of life questionnaire version 4.
II. To assess the toxicity using the Cancer Therapy Evaluation Program (CTEP) National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE version 4.0).
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
- •Have an Eastern Cooperative Oncology Group (ECOG) performance status of =< 2
- •Patients with Tl/T2 squamous cell carcinoma of the oral cavity with or without extension to the oropharynx
- •Histologically confirmed squamous cell carcinoma of the target tumor(s)
- •Tumor thickness is 4 mm or less (in the judgment of the physician)
- •Computed tomography (CT) of the neck to confirm staging
- •Tumor accessible for unrestricted illumination for photodynamic therapy (PDT) (accessibility as determined by the physician)
- •Life expectancy of at least 12 months in the judgment of the physician
- •Patients of child-bearing potential must agree to use adequate contraceptive methods (e.g., 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
- •Patient or legal representative must understand the investigational nature of this study and sign an Institutional Review Board approved written informed consent form prior to receiving any study related procedure
排除标准
- •Patients who have had chemotherapy or radiotherapy or targeted agents within 4 weeks (6 weeks for nitrosoureas or mitomycin C) prior to entering the study or those who have not recovered from adverse events due to agents administered more than 4 weeks earlier
- •Patients with known brain metastases should be excluded from this clinical trial
- •Patients with porphyria, or with known hypersensitivity to porphyrins or porphyrin-like compounds
- •White blood cells (WBC) < 4,000
- •Total serum bilirubin > 2 mg/dL
- •Serum creatinine > 2 mg/dL
- •Alkaline phosphatase (hepatic) > 3 times the upper normal limit
- •Serum glutamic oxaloacetic transaminase (SGOT) > 3 times the upper normal limit
- •Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements
- •Nodal disease as detected by clinical exam or CT
- •Pregnant or nursing female patients
- •Unwilling or unable to follow protocol requirements
- •Any condition which in the Investigator's opinion deems the patient an unsuitable candidate to receive study drug
- •Received an investigational agent within 30 days prior to enrollment
研究组 & 干预措施
Arm I (standard of care surgery)
Patients undergo standard of care surgery on day 1.
干预措施: therapeutic conventional surgery (Procedure)
Arm II (HPPH, photodynamic therapy)
Patients receive HPPH IV over 1 hour on day 0. Approximately 24 hours later, patients undergo photodynamic therapy on day 1.
干预措施: HPPH (Drug)
Arm II (HPPH, photodynamic therapy)
Patients receive HPPH IV over 1 hour on day 0. Approximately 24 hours later, patients undergo photodynamic therapy on day 1.
干预措施: Light Infusion Therapy™ (Device)
结局指标
主要结局
Objective tumor response assessed according to Response Evaluation Criteria in Solid Tumors version 1.1
时间窗: 3 months after treatment
Objective tumor response will be tabulated overall. Tumor response will be determined by comparing photographs of the treated site (with reference ruler) before and after PDT. Efficacy (e.g., tumor response) will be estimated using simple relative frequencies. The corresponding 95% confidence intervals for the estimated probabilities will be computed using the method proposed in Clopper and Pearson.
Changes in quality of life evaluated by the University of Washington Quality of Life Questionnaire version 4
时间窗: Baseline to up to 5 years
In the analysis of QoL simple data analyses will initially take place including individual patient level profile plots and overall mean plots used to examining the mean structure. Formal statistical examination of longitudinal patterns will be done through the use of a mixed model. All tests will be two-sided and tested at a 0.05 nominal significance level. Standard diagnostic plots will be used to assess model fit and transformations of variables may be considered in order to meet statistical assumptions.
次要结局
- Frequency of toxicity graded according to NCI CTCAE version 4.0(Up to 6 weeks after treatment)