Preoperative Hypofractionated Radiation Followed by Surgery in Advanced Oral Cavity Squamous Cell Carcinoma
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 试验地点
- 4
- 主要终点
- Locoregional control
研究概览
简要总结
This phase I/II trial studies how well hypofractionated radiation therapy followed by surgery works in treating patients with squamous cell carcinoma of the oral cavity that has spread to other places in the body. Hypofractionated radiation therapy delivers higher doses of radiation therapy over a shorter period of time and may kill more tumor cells and have fewer side effects. Giving hypofractionated radiation therapy before surgery may shrink the tumor making it easier to be removed, may reduce the risk of the cancer coming back, and may be a better treatment for squamous cell carcinoma of the oral cavity.
详细描述
PRIMARY OBJECTIVES:
I. 2 year locoregional control for advanced oral cavity squamous cell carcinoma (SCC) treated with preoperative hypofractionated radiation followed by surgical resection.
SECONDARY OBJECTIVES:
I. Rate of pathologic complete response after preoperative hypofractionated radiation at both the primary site and lymph nodes (LN).
II. Rate of radiologic complete and partial response (computed tomography [CT] neck with intravenous [IV] contrast performed before and after radiation therapy, judged per Response Evaluation Criteria In Solid Tumors [RECIST] 1.1 criteria).
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patient is willing to sign study specific informed consent
- •Pathologically proven (histologically or cytologically) diagnosis of squamous cell carcinoma (including histological variants like papillary squamous cell carcinoma and basaloid squamous cell carcinoma)
- •Advanced stage but not metastatic SCC of the oral cavity (III or IVa, b); sites in the oral cavity include oral tongue, floor of mouth, hard palate, gingiva, buccal mucosa, retromolar trigone; often, head & neck tumors may involve other adjacent sites, such as the oropharynx- in these cases, the criteria is that the tumor must appear to have originated in the oral cavity per ear, nose, and throat (ENT)/radiation oncology
- •Patient is deemed to be a surgical candidate by ENT
- •Karnofsky performance status (KPS) 0-2
- •For women of childbearing potential, a negative serum pregnancy test completed prior to any radiation therapy
- •Patients with human immunodeficiency virus (HIV) infection are not automatically excluded, but must meet the following criteria: cluster of differentiation 4 (CD4) count is > 499/cu mm and their viral load is < 50 copies/ml; use of highly active antiretroviral therapy (HAART) is allowed
- •Patient is free of any prior invasive malignancy (except non-melanomatous skin cancer) for a minimum of the past 3 years
排除标准
- •Metastatic disease beyond the neck or supraclavicular area as demonstrated by positron emission tomography (PET)/CT or biopsy
- •KPS 3 or worse
- •Gross disease in the retrostyloid (high level II) or retropharyngeal lymph node regions by CT or PET/CT
- •Patients may not have received previous therapy for their head and neck SCC, including chemotherapy, radiation therapy, or surgery beyond biopsy
- •Second primary malignancy; exceptions are 1) patient had a second primary malignancy but has been treated and disease free for at least 3 years, 2) in situ carcinoma (e.g. in situ carcinoma of the cervix), 3) non-melanomatous carcinoma of the skin
- •Serious concomitant systemic disorders (including active infections) that would compromise the safety of the patient or compromise the patient's ability to complete the study, at the discretion of the investigator; this includes scleroderma
- •Women who are pregnant; women of childbearing age must agree to undergo a urine pregnancy test prior to therapy and to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry, for the duration of study participation and for 6 months after; should a woman become pregnant or suspect she is pregnant while participating in this study, she should inform her treating physician immediately
- •Patient is deemed to not be a surgical candidate by ENT
结局指标
主要结局
Locoregional control
时间窗: 2 years
Will be assessed using both clinical and radiographic means, and recurrence will be confirmed by biopsy.
次要结局
- Changes from CT to CT (after radiation), such as changes in tumor volume or longest tumor diameter(Baseline to up to 2 years)
- Rate of complete and partial response per imaging, judged per RECIST 1.1 criteria(Up to 2 years)
- Expression of molecular markers(Up to 24 hours after initial radiation treatment)
- Rate of pathologic complete response after preoperative hypofractionated radiation at both the primary site and lymph nodes(Up to 2 years)
- Incidence of long term grade III/IV/V toxicity, graded according to the NCI CTCAE, version 4.0(Up to 2 years)
- Rate of flap complications (rate of flap revisions and flap complete revisions required)(Up to 2 years)
- Quantitative imaging characteristics in the pre-treatment PET/CT(Baseline)
- Incidence of short term grade III/IV/V toxicity, graded according to the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE), version 4.0(Up to 60 days post-surgery)
研究者
Sung Kim, MD, Residency and Clinical Director
Residency Director
Rutgers Cancer Institute of New Jersey