Linear Energy Transfer (LET)-Optimized Intensity Modulated Proton Therapy (IMPT) as a Component of Definitive Chemoradiation for Newly Diagnosed Squamous Cell Carcinoma of the Anal Canal: a Feasibility Trial
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 8
- 试验地点
- 1
- 主要终点
- Acute Toxicity
研究概览
简要总结
This phase II trial studies the side effects of LET-IMPT and standard chemotherapy, and how well they work in treating patients with newly diagnosed stage I-III anal canal squamous cell cancer. LET-IMPT is a type of radiation therapy that uses high energy proton "beamlets" to "paint" the radiation dose into the target and may help to kill tumor cells and shrink tumors. Giving LET-IMPT and standard chemotherapy may work better in treating patients with anal canal squamous cell cancer.
详细描述
PRIMARY OBJECTIVES:
I. To assess physician-reported acute grade 3 or greater gastrointestinal, genitourinary and hematologic toxicities at 12 weeks post-treatment for patients treated with linear energy transfer (LET)-optimized, intensity-modulated proton therapy (IMPT) and compare to contemporary controls treated with volume modulated arc therapy (VMAT) to determine the feasibility of this outcome for a future randomized trial.
SECONDARY OBJECTIVES:
I. To assess the feasibility of enrolling patients on a prospective trial delivering LET-optimized IMPT for newly diagnosed, non-metastatic anal cancer.
II. To develop guidelines and workflow to create and deliver anal canal cancer treatments using LET-optimized IMPT.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Histologically-proven, non-metastatic invasive primary squamous cell carcinoma of the anal canal (stages I, II, and III)
- •History/physical examination including documentation of the primary anal lesion size, distance from the anal verge and anal sphincter tone within 60 days prior to registration
- •Anal examination with biopsy on either colonoscopy, sigmoidoscopy, rigid proctoscopy or anoscopy
- •Computed tomography (CT) scan of the chest and abdomen with contrast or contrast-enhanced positron emission tomography (PET)/CT scan within 60 days of registration unless the patient has a documented contrast allergy
- •CT scan of pelvis with contrast or contrast-enhanced PET/CT scan within 60 days of registration unless the patient has a documented contrast allergy
- •Zubrod performance status of 0-1 within 60 days prior to registration
- •Absolute neutrophil count (ANC) >=1.8 K/ul, cannot be achieved through granulocyte-colony stimulating factor (GCSF) (within 30 days prior to study registration)
- •Platelets >= 100 K/uL, cannot be achieved through transfusion (within 30 days prior to study registration)
- •Hemoglobin >= 8 g/dL, cannot be achieved through transfusion (within 30 days prior to study registration)
- •Serum creatinine =< 1.5 mg/dL (within 30 days prior to study registration)
- •Bilirubin =< 1.4 mg/dL, except in the case of patients with Gilbert's disease (within 30 days prior to study registration)
- •White blood cells (WBC) >= 3000/microliter (within 30 days prior to study registration)
- •Aspartate transaminase (AST)/alanine transaminase (ALT) < 3 x the upper limit of normal (within 30 days prior to study registration)
- •International normalized ratio (INR) =< 1.5 (within 30 days prior to study registration)
- •Human Immunodeficiency Virus (HIV) test must be done within 30 days of study registration. If HIV positive, CD4 count must be obtained within 30 days of study registration
- •Note: HIV positive patients are eligible for this study if they have a CD4 count > 400 cells/mm^3
- •The patient must either have insurance authorization or otherwise secure funding to cover IMPT
- •The patient must be able to receive concurrent chemotherapy
排除标准
- •Prior invasive malignancy (except non-melanomatous skin cancer), unless disease free for a minimum of 3 years
- •Prior systemic chemotherapy for anal cancer
- •Prior radiotherapy to the pelvis that would result in overlap of radiation fields
- •Evidence of distant metastatic disease (M1)
- •Prior surgery to the anal canal that removed all macroscopic anal cancer
- •Women of childbearing potential or men who do not agree to use a medically effective form of birth control throughout their participation in the treatment phase of the study
- •Severe, active co-morbidity defined as follows: unstable angina and/or congestive heart failure requiring hospitalization within the last 6 months; transmural myocardial infarction within the last 6 months; acute bacterial or fungal infection requiring intravenous antibiotics at the time of registration; chronic obstructive pulmonary disease exacerbation or other respiratory illness requiring hospitalization or precluding study therapy at the time of registration; hepatic insufficiency resulting in clinical jaundice and/or coagulation defects; HIV positive with a CD4 count < 400 cells/mm^3; other immuno-compromised status; women who are pregnant or lactating; uncontrolled infection as deemed by the principal investigator (PI); patient incarceration
研究组 & 干预措施
Treatment (LET-IMPT, chemotherapy)
Patients undergo linear energy transfer-optimized intensity modulated proton therapy 5 times per week for 5-6 weeks. Patients also receive standard cisplatin and fluorouracil IV weekly for up to 6 weeks in the absence of disease progression or unacceptable toxicity.
干预措施: Quality-of-Life Assessment (Procedure)
Treatment (LET-IMPT, chemotherapy)
Patients undergo linear energy transfer-optimized intensity modulated proton therapy 5 times per week for 5-6 weeks. Patients also receive standard cisplatin and fluorouracil IV weekly for up to 6 weeks in the absence of disease progression or unacceptable toxicity.
干预措施: Questionnaire Administration (Other)
Treatment (LET-IMPT, chemotherapy)
Patients undergo linear energy transfer-optimized intensity modulated proton therapy 5 times per week for 5-6 weeks. Patients also receive standard cisplatin and fluorouracil IV weekly for up to 6 weeks in the absence of disease progression or unacceptable toxicity.
干预措施: Cisplatin (Drug)
Treatment (LET-IMPT, chemotherapy)
Patients undergo linear energy transfer-optimized intensity modulated proton therapy 5 times per week for 5-6 weeks. Patients also receive standard cisplatin and fluorouracil IV weekly for up to 6 weeks in the absence of disease progression or unacceptable toxicity.
干预措施: Fluorouracil (Drug)
Treatment (LET-IMPT, chemotherapy)
Patients undergo linear energy transfer-optimized intensity modulated proton therapy 5 times per week for 5-6 weeks. Patients also receive standard cisplatin and fluorouracil IV weekly for up to 6 weeks in the absence of disease progression or unacceptable toxicity.
干预措施: Linear Energy Transfer-Optimized Intensity Modulated Proton Therapy (Radiation)
结局指标
主要结局
Acute Toxicity
时间窗: Acute physician reported toxicity from start of treatment 12 weeks post-treatment
Number (percentage) of patients with physician-reported acute G3+ GI, GU and heme toxicities
次要结局
- Complete Response at 12 Weeks(12 weeks)
- Local Progression Free Survival at 24 Months(24 months)
- Distant Metastasis-free Survival at 24 Months.(24 months)
- Complete Response at 24 Weeks(24 weeks)
- Overall Survival at 24 Months(24 months)