A Pilot Study to Evaluate the Utility of Interim Digital PET/CT in Predicting Outcomes for Locally Advanced Oropharyngeal Cancer
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 试验地点
- 2
- 主要终点
- Quantitative assessments of digital positron emission tomography (dPET) characteristics generated at early time points during treatment
研究概览
简要总结
This trial studies how well digital PET scan works in predicting outcomes in patients with oropharyngeal cancer that has spread from where it started to nearby tissue or lymph nodes (locally advanced). The development of digital detectors for PET is a technological improvement in medical imaging that could potentially impact many areas of clinical oncology, including staging, radiation planning accuracy, and the assessment of treatment response. Digital technology may improve PET imaging performance by providing better timing, energy and spatial resolution, higher count rate capabilities and linearity, increased contrast, and reduced noise. Utilizing digital PET scan, may work better in predicting outcomes and treatment response in patients with oropharyngeal cancer compared to conventional PET.
详细描述
PRIMARY OBJECTIVE:
I. To evaluate the utility of early (i.e. during treatment) digital positron emission tomography (dPET) as a diagnostic tool to predict local control 6 months after definitive chemoradiation for patients with locally advanced oropharyngeal carcinoma.
SECONDARY OBJECTIVES:
I. To study the association between dynamic dPET parameters taken at early time points (i.e. during treatment) and CR on PET after definitive chemoradiation.
II. To study the association between dynamic dPET parameters taken at early time points (i.e. during) treatment and 2 year local control after definitive chemoradiation.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Diagnostic
- 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
- •Patient who will undergo definitive radiation with concurrent chemotherapy with cisplatin 40 mg/m^2 weekly (preferred) or high dose cisplatin 100 mg/m^2 for histologically confirmed locally advanced squamous cell carcinoma of the oropharynx
- •Patient must have clinically or radiographically evident measurable disease at the primary site and at nodal station(s). Tonsillectomy or local excision of the primary or nodal disease is not permitted
- •p16 and/or human papillomavirus (HPV) status obtained on biopsy specimen (archival or fresh)
- •Patients must provide their personal smoking history prior to registration
- •Patients must fall into one of the following stage (American Joint Committee on Cancer [AJCC] 8) and risk groups based on pre-treatment work-up and smoking history:
- •Low risk classification:
- •p16 and/or HPV positive, T1-3, N1-2, M0 with =< 10 pack years smoking history OR
- •Intermediate risk classification:
- •p16 and/or HPV positive, T4, N3, M0 and/or HPV positive with > 10 pack year smoking history
- •HPV negative, T1-3, N1-2b, M0, with =< 10 pack years smoking history OR
- •High risk classification:
- •p16 and/or HPV negative, T4, N3, M0
- •p16 and/or HPV negative with > 10 pack year smoking history
- •Patients with no contraindications to PET imaging or cisplatin
- •No prior history of radiation therapy
- •Patient has an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
- •Patients with remaining teeth must undergo a dental evaluation prior to enrolment
- •Ability to provide informed consent obtained prior to participation in the study and any related procedures being performed
- •Women of child-bearing potential (WOCBP) must have a negative pregnancy test within 14 days of the first administration of study treatment. Urine human chorionic gonadotropin (HCG) is an acceptable pregnancy assessment
- •Women of child-bearing potential and men who are sexually active should be willing and able to use medically acceptable forms of contraception throughout the treatment phase of the trial and until 60 days following the last study treatment
排除标准
- •Prior cancers except non-melanoma skin cancer outside of the head and neck unless disease free for 5 years
- •Carcinoma of unknown primary, even if p16 positive
- •Clinical or radiologic evidence of metastatic disease as defined by disease below the clavicles
- •Simultaneous primary cancers or separate bilateral primary tumor sites with the exception of patients with bilateral tonsil cancers
- •Subjects who are breast-feeding, or have a positive pregnancy test will be excluded from the study. Should a woman become pregnant or suspect she is pregnant while participating in this study, she should inform her treating physician immediately
- •Medical contraindications to PET imaging (e.g. pregnancy, nursing mothers, weight greater than 420 pounds)
- •Medical contraindications to cisplatin or prior allergic reaction to cisplatin
- •Subjects who are unable to receive intravenous contrast due to a contrast allergy or poor renal function
- •Subjects who are prisoners
- •Any serious and/or unstable pre-existing medical disorder (aside from malignancy exception above), psychiatric disorder, or other conditions that could interfere with subject?s safety, obtaining informed consent or compliance to the study procedures, in the opinion of the Investigator. This could include severe, active co-morbidities such as:
- •Uncontrolled cardiac disease (hypertension, unstable angina, myocardial infarction within last 6 months, uncontrolled congestive heart failure, cardiomyopathy with decreased ejection fraction)
- •Uncontrolled diabetes
- •Acute bacterial or fungal infection requiring intravenous antibiotics at time of registration
- •Chronic obstructive pulmonary disease exacerbation or other respiratory illness requiring hospitalization or precluding study therapy within 30 days of registration
结局指标
主要结局
Quantitative assessments of digital positron emission tomography (dPET) characteristics generated at early time points during treatment
时间窗: Up to 2 years
For each of the promising dPET parameters identified in the primary analysis we will examine potential cut-points to be used to best predict 6-month response/non-response using receiver operating characteristic (ROC) methods. Here we will examine specificity, sensitivity, positive predictive value and negative predictive values for each promising parameter to allow for preliminary data to be generated to anticipate which parameters may warrant future study.
次要结局
- Tumor burden(Up to 2 years)
- Response rate for each patient local control(At 2 years)
- Metabolic tumor volume (MTV) from digital/conventional PET(At 3 months)
- Standard uptake volume (SUV) from digital/conventional PET(At 3 months)
- Progression-free survival (PFS)(Up to 2 years)
- Total lesion glycolysis (TLG) from digital/conventional PET(At 3 months)
研究者
Eric Miller
Principal Investigator
Ohio State University Comprehensive Cancer Center