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老年人 HPV 相关口咽癌的剂量调整放化疗 ((DACHOC-E))

2026年9月28日 更新者:Omar Mahmoud

老年 HPV 相关口咽癌剂量调整放化疗的试点可行性试验 (DACHOC-E)

Previous studies of this type of head and necl cancer have shown high rates of cancer control but result in many short and long term side effects when treated with high dose radiation and chemotherapy. Recently, investigators have noticed similar high rates of cancer control in small numbers of patients who receive less intensive treatments using lower doses of radiation, smaller radiation fields with chemotherapy. It is expected that the side effects of treatment with lower doses of radiation would be less.

For this reason this study is looking at a different regimen of reducing the intensity of the treatment.

The purpose of this study is to compare any good and bad effects of using lower dose smaller fields radiation therapy and chemotherapy with published outcomes. This study will allow the researchers to know whether these different approaches are better, the same, or worse than the usual approach. To be better, the study approach should result in the same survival rate of the usual approach (about 85 out of 100 patients alive and free of cancer at 2 years) but with less long-term side effects.

研究概览

详细说明

There will be about 30 people taking part in this study. This study has one study group. All the people on the study will receive radiation therapy once a day, 5 days a week (for a total of 55 Gy over 5 weeks) and chemotherapy, cisplatin, (given through the vein for about 30-60 minutes) once a week for 5 weeks.

Medications and saline solutions to prevent side effects of chemotherapy may also be given by vein and may prolong your time in the chemotherapy clinic to as much as 4-6 hours.

Standard regimen not delivered on this study pertains to radiation therapy and chemotherapy, cisplatin in a schedule of 5 treatments a week for a total of 69.96 Gy over 6.5 weeks.

研究类型

介入性

注册 (估计的)

20

阶段

  • 不适用

联系人和位置

本节提供了进行研究的人员的详细联系信息,以及有关进行该研究的地点的信息。

学习联系方式

研究联系人备份

学习地点

    • Florida
      • Jacksonville、Florida、美国、32207

参与标准

研究人员寻找符合特定描述的人,称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

65年 至 99年 (年长者)

接受健康志愿者

不

有资格学习的性别

全部

描述

Inclusion Criteria:

  • Pathologically proven diagnosis of squamous cell carcinoma of the oropharynx (tonsil, base of tongue, soft palate, or oropharyngeal walls)
  • Patients must have clinically or radiographically evident measurable disease at the primary site or at nodal stations.
  • P16-positive based on local site immunohistochemical tissue staining
  • Clinical stage T1-3, N1-2, M0 (AJCC, 8th ed.)
  • Age ≥ 65.
  • Normal organ and marrow function within 14 days prior to registration defined as follows:
  • Absolute neutrophil count ≥ 1,500/mcL
  • Platelets ≥ 100,000/mcL
  • Hemoglobin ≥ 8.0 g/dL
  • Total bilirubin ≤ 1.5× institutional upper limit of normal (ULN)
  • AST(SGOT) or ALT(SGPT) ≤ 3.0 × institutional ULN
  • Serum creatinine ≤ 1.5× ULN

Exclusion Criteria:

  • Metastatic disease
  • Recurrent disease after primary management Cancers with center of mass is outside the oropharyngeal boundaries
  • Synchronous double primaries
  • Prior radiotherapy for lymphoma or other malignancy
  • Prior systemic therapy including immunotherapy
  • Severe active comorbidity where life expectancy is <1 year.
  • Autoimmune disease
  • Uncontrolled HIV

学习计划

本节提供研究计划的详细信息,包括研究的设计方式和研究的衡量标准。

研究是如何设计的?

设计细节

  • 主要用途:治疗
  • 分配:不适用
  • 介入模型:单组作业
  • 屏蔽:无(打开标签)

武器和干预

参与者组/臂
干预/治疗
实验性的:Experimental

Cisplatin: 30-40 mg/m2/week, every week during radiation. Dose should be based on actual body weight. The first cisplatin infusion should be started within 24 hours before or after the first scheduled radiation treatment.

Intensity Modulated Radiation Therapy (IMRT) and Image-Guided Radiation Therapy (IGRT) are mandatory for this study.

55 Gy radiation in 5 weeks using 5 fractions per week + Cisplatin every week

Instead of standard bilateral or extensive neck fields, the current radiation fields will cover disease with only 3cm expansion. The clinical target volumes doses are biologically equivalent to the standard but given in a shorter hypofractionated approach.

研究衡量的是什么?

主要结果指标

结果测量
措施说明
大体时间
Two-year progression free survival
大体时间:2 years

Assuming the primary endpoint (non-inferior 2 year locoregional control) is met and both of these toxicity outcome goals are met, then concurrent short course radiotherapy would be considered an effective and less toxic alternative to concurrent standard arm, in locally advanced HPV-associated carcinoma of the oropharynx.

2 years

次要结果测量

结果测量
措施说明
大体时间
Benefit and Tolerance of Treatment
大体时间:2 years

Frailty index G8 score 14 as major determinant of benefit and tolerance to treatment through:

Per prior study score <14 (1-17) is an indicator of frailty. The frailty as a factor in completing therapy (yes or no) and number of days break from therapy will be used as a variable.

G20 frailty index (G-20 is the actual name and not abbreviation) is as follows:

A Has food intake declined over the past 3 months due to loss of appetite, digestive problems, chewing or swallowing difficulties? B Weight loss during the last 3 months C Mobility D Neuropsychological problems E Body Mass Index (BMI (weight in kg) / (height in m²) F Takes more than 3 medications per day G In comparison with other people of the same age, how does the patient consider his/her health status? H Age

2 years
Acute Toxicity
大体时间:2 years

Acute toxicity (Grade 3 or higher)

2 years
Late toxicity
大体时间:2 years

Late toxicity (Grade 3 or higher)

2 years
Failure pattern
大体时间:2 years

Pattern failure (local in field, local marginal miss, local regional failure, distant failure, combination of the above).

As some of the patient may have recurrence in the radiation fields, this will be termed local recurrence. Recurrence outside the radiation fields but in the head and neck area will be quantified as regional failure. Failure outside the head and neck area will be classified as distant failure. This outcome will be quantified as global number of failure out of the 20 patients and their distribution will be quantified in a diagram as explain above.

2 years

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

赞助

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查,以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始 (实际的)

2025年12月15日

初级完成 (估计的)

2027年9月30日

研究完成 (估计的)

2027年9月30日

研究注册日期

首次提交

2024年2月22日

首先提交符合 QC 标准的

2024年3月6日

首次发布 (实际的)

2024年3月13日

研究记录更新

最后更新发布 (实际的)

2026年9月29日

上次提交的符合 QC 标准的更新

2026年9月28日

最后验证

2026年9月1日

更多信息

与本研究相关的术语

计划个人参与者数据 (IPD)

计划共享个人参与者数据 (IPD)?

不

药物和器械信息、研究文件

研究美国 FDA 监管的药品

不

研究美国 FDA 监管的设备产品

不

此信息直接从 clinicaltrials.gov 网站检索,没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求,请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改,我们的网站上也会自动更新.

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