Phase II Study of De-intensification of Radiation and Chemotherapy for Low-Risk HPV-related Oropharyngeal Squamous Cell Carcinoma
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 45
- 试验地点
- 5
- 主要终点
- Pathologic Complete Response Rate After De-escalated CRT in HPV-positive and/or p16 Positive Oropharyngeal Squamous Cell Carcinoma (OPSCC).
研究概览
简要总结
The purpose of this research study is to learn about the effectiveness of using lower-intensity radiation and chemotherapy to treat human papillomavirus (HPV) associated low-risk oropharyngeal and/or unknown primary squamous cell carcinomas of the head and neck. The cure rate for this type of cancer is estimated to be high, > 90%. The standard treatment for this cancer is 7 weeks of radiation with 3 high doses of cisplatin. Sometimes surgery is performed afterwards. This standard regimen causes a lot of side effects and long term complications. This study is evaluating whether a lower dose of radiation and chemotherapy may provide a similar cure rate as the longer, more intensive standard regimen. Patients in this study will receive 1 less week of radiation and a lower weekly dose of chemotherapy followed by a limited surgical evaluation.
详细描述
The aim is to evaluate the pathological response rate of HPV positive and/or p16 positive low-risk oropharyngeal squamous cell carcinoma (OPSCC) after de-intensified chemoradiotherapy (CRT). Patients will receive 54 to 60 Gy of Intensity Modulated Radiotherapy (IMRT) with concurrent weekly intravenous cisplatin (30 mg/m2). Diagnostic imaging (CT and/or MRI) will be obtained 4 to 8 weeks after completion of CRT to assess response. All patients will have surgical resection of any clinically apparent residual primary tumor or biopsy of the primary site if there is no evidence of residual tumor and will undergo a limited neck dissection to encompass at least those nodal level(s) that were positive pre-treatment, 4 to 14 weeks after CRT. The primary endpoint of this study is the rate of pathological complete response (pCR) after CRT. Longitudinal assessments of quality of life and patient reported outcomes will be obtained prior to, during, and after CRT.
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
- •≥ 18 years of age
- •T0-3, N0 to N2c, M0 squamous cell carcinoma of the oropharynx
- •Biopsy proven squamous cell carcinoma that is HPV and/or p16 positive
- •≤ 10 pack-years smoking history or > 5 years of abstinence from smoking
- •History/physical examination within 8 weeks prior to registration
- •Radiologic confirmation of the absence of hematogenous metastasis within 12 weeks prior to registration.
- •The Eastern Cooperative Oncology Group (ECOG) Performance Status 0-1
- •Complete Blood Count (CBC)/differential obtained within 4 weeks prior to registration, with adequate bone marrow function defined as follows: Absolute neutrophil count (ANC) ≥ 1,800 cells/mm3; Platelets ≥ 100,000 cells/mm3; Hemoglobin ≥ 8.0 g/dl.
- •Adequate renal and hepatic function within 4 weeks prior to registration, defined as follows: Serum creatinine < 2.0 mg/dl; Total bilirubin < 2 x the institutional upper limit of normal (ULN); aspartate aminotransferase (AST) or alanine aminotransferase (ALT) < 3 x the institutional ULN.
- •Negative serum pregnancy test within 2 weeks prior to registration for women of childbearing potential.
- •Women of childbearing potential and male participants who are sexually active must practice adequate contraception during treatment and for 6 weeks following treatment.
- •Patients must be deemed able to comply with the treatment plan and follow-up schedule.
- •Patients must provide study specific informed consent prior to study entry.
排除标准
- •Prior history of radiation therapy to the head and neck
- •Prior history of head and neck cancer.
- •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; Note, however, coagulation parameters are not required for entry into this protocol; Pre-existing ≥ grade 2 neuropathy; Prior organ transplant.
- •Known HIV positive
- •Significant pre-existing hearing loss, as defined by the patient or treating physician.
研究组 & 干预措施
De-escalated Radiation and Chemotherapy
Patients will receive 54 to 60 Gy of Intensity Modulated Radiotherapy (IMRT) with concurrent weekly intravenous cisplatin (30 mg/m2). Diagnostic imaging (CT and/or MRI) will be obtained 4 to 8 weeks after completion of CRT to assess response. All patients will have surgical resection of any clinically apparent residual primary tumor or biopsy of the primary site if there is no evidence of residual tumor and will undergo a limited neck dissection to encompass at least those nodal level(s) that were positive pre-treatment, 4 to 14 weeks after CRT.
干预措施: Intensity Modulated Radiotherapy (IMRT) (Radiation)
De-escalated Radiation and Chemotherapy
Patients will receive 54 to 60 Gy of Intensity Modulated Radiotherapy (IMRT) with concurrent weekly intravenous cisplatin (30 mg/m2). Diagnostic imaging (CT and/or MRI) will be obtained 4 to 8 weeks after completion of CRT to assess response. All patients will have surgical resection of any clinically apparent residual primary tumor or biopsy of the primary site if there is no evidence of residual tumor and will undergo a limited neck dissection to encompass at least those nodal level(s) that were positive pre-treatment, 4 to 14 weeks after CRT.
干预措施: Cisplatin (Drug)
De-escalated Radiation and Chemotherapy
Patients will receive 54 to 60 Gy of Intensity Modulated Radiotherapy (IMRT) with concurrent weekly intravenous cisplatin (30 mg/m2). Diagnostic imaging (CT and/or MRI) will be obtained 4 to 8 weeks after completion of CRT to assess response. All patients will have surgical resection of any clinically apparent residual primary tumor or biopsy of the primary site if there is no evidence of residual tumor and will undergo a limited neck dissection to encompass at least those nodal level(s) that were positive pre-treatment, 4 to 14 weeks after CRT.
干预措施: Limited surgical evaluation (Procedure)
结局指标
主要结局
Pathologic Complete Response Rate After De-escalated CRT in HPV-positive and/or p16 Positive Oropharyngeal Squamous Cell Carcinoma (OPSCC).
时间窗: 6 to 14 weeks after the last patient is enrolled, or approximately 24 to 32 months after study being opened
Pathologic Complete Response Rate is defined as no evidence of residual viable cancer in the evaluated pathological specimens.
次要结局
- Two-Year Local Control(Median follow-up was 36 months with a range of 5-53 months)
- Regional Control(Median follow-up was 36 months with a range of 5-53 months)
- Overall Survival Rate(Median follow-up was 36 months with a range of 5-53 months.)
- Cause-Specific Survival(The median follow-up was 36 months with a range of 5-53 months)
- Distant Metastases Free Survival(the median follow-up was 36 months with a range of)
- European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ)-H&N-35(Prior to CRT, 4-8 weeks after CRT, follow-up visits for 2 years after CRT)
- European Organization for Research and Treatment of Cancer (EORTC) QLQ-C30 Global Health Status/QoL(Prior to CRT, 4-8 weeks after CRT, follow-up visits for 2 years after CRT)
- The Eating Assessment Tool (EAT-10) Composite Score(Prior to CRT, 4-8 weeks after CRT, follow-up visits for 2 years after CRT)
- The Rosenbek Penetration Aspiration Scale(Prior to CRT and 4-8 weeks after completion of CRT)