A Randomized Multicenter Phase II Study Using (2-1[Heyloxyethyl]-2-Devinylpyropheophorbide-a) (HPPH) With PDT Versus Standard of Care Surgery for Patients With T1/T2 N0 Squamous Cell Carcinoma of the Oral Cavity
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 入组人数
- 2
- 试验地点
- 2
- 主要终点
- Rate of Tumor Response as Evaluated by Response Evaluation Criteria in Solid Tumors Version 1.1
研究概览
简要总结
This randomized phase II clinical trial studies how well photodynamic therapy with HPPH works compared to standard of care surgery in treating patients with oral cavity cancer. Photodynamic therapy can destroy or control disease by using a combination of drug, such as HPPH, and light and may be as effective as surgery in treating patients with oral cavity cancer.
详细描述
PRIMARY OBJECTIVES:
I. To test the non-inferiority of photodynamic therapy (PDT) to standard of care surgery by comparing the rate of tumor response after PDT to those observed after surgery, at 24 months post treatment.
SECONDARY OBJECTIVES:
I. To determine quality of life (QoL) at 6, 12, 18 and 24 months post PDT or surgery.
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
- •Participants with previously untreated T1/T2 N0 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 (measured clinically and/or by computed tomography [CT] or magnetic resonance imaging [MRI] scan)
- •CT or MRI 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
- •Participants 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 is participating in this study, she should inform her treating physician immediately
- •Participant 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
- •Those 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
- •Those with known brain metastases should be excluded from this clinical trial because of their poor prognosis and because they often develop progressive neurologic dysfunction that would confound the evaluation of neurologic and other adverse events
- •Those 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) or serum glutamic-oxaloacetic transaminase (SGOT) > 3 times the upper normal limit
- •Diagnostic biopsy reveals perineural invasion (PNI) and/or lymphovascular invasion (LVI)
- •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 females
- •Unwilling or unable to follow protocol requirements
- •Any condition which in the investigator's opinion deems the participant an unsuitable candidate to receive study drug
- •Received an investigational agent within 30 days prior to enrollment
- •Trismus or compromised airway
- •Previous treatment in the target tumor area
研究组 & 干预措施
Arm II (HPPH, PDT)
Patients receive HPPH IV over 1 hour on day 0 and undergo PDT on day 1.
干预措施: Quality-of-Life Assessment (Other)
Arm I (surgery)
Patients undergo standard of care surgery on day 1.
干预措施: Quality-of-Life Assessment (Other)
Arm I (surgery)
Patients undergo standard of care surgery on day 1.
干预措施: Therapeutic Conventional Surgery (Procedure)
Arm II (HPPH, PDT)
Patients receive HPPH IV over 1 hour on day 0 and undergo PDT on day 1.
干预措施: HPPH (Drug)
Arm II (HPPH, PDT)
Patients receive HPPH IV over 1 hour on day 0 and undergo PDT on day 1.
干预措施: Laboratory Biomarker Analysis (Other)
Arm II (HPPH, PDT)
Patients receive HPPH IV over 1 hour on day 0 and undergo PDT on day 1.
干预措施: Photodynamic Therapy (Drug)
结局指标
主要结局
Rate of Tumor Response as Evaluated by Response Evaluation Criteria in Solid Tumors Version 1.1
时间窗: At 24 months
Objective tumor response will be tabulated overall.
次要结局
- Change in Quality of Life as Measured by the University of Washington Quality of Life Questionnaire Version 4(Baseline up to 24 months)
- Adverse Events as Graded by CTCAE Version 4.0 Are Reported(Up to 30 days after administration of HPPH)