Comparison of Two Hypofractionated Radiotherapy Regimens for the Palliative Management of Patients With Head and Neck Cancers: Quad Shot Versus Split Course
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 40
- 主要终点
- Objective Local Tumor Response Rate Assessed by RECIST 1.1
研究概览
简要总结
Head and neck cancer in its advanced, incurable stage causes severe symptoms such as pain, trouble swallowing, and bleeding. Palliative radiation therapy is frequently used to relieve these symptoms and improve the patient's quality of life. Currently, a standard treatment approach is the "Split Course" regimen, which takes several weeks and can cause side effects that are difficult for patients to tolerate. This study aims to evaluate a shorter, alternative radiation treatment called "Quad Shot."
The hypothesis of this study is that the Quad Shot regimen will be as effective as the Split Course regimen in shrinking the tumor and controlling local symptoms, but will offer a better quality of life by reducing the overall treatment time and the severity of side effects. To test this, researchers will assign participants by chance to receive either the Quad Shot or the Split Course regimen. The research team will closely monitor tumor response, treatment side effects, and patients' quality of life for up to six months.
详细描述
The optimal palliative radiotherapy regimen for incurable head and neck squamous cell carcinoma remains undefined. The standard approach at the Instituto Nacional de Cancerologia is the split-course regimen. Although effective for local symptom control, it requires a prolonged treatment course and is associated with significant acute toxicities that can compromise the comfort and quality of life of frail patients with a limited life expectancy.
The Quad Shot regimen, a hypofractionated approach initially evaluated in the RTOG 8502 trial for pelvic malignancies, offers a substantially shorter treatment duration. It has shown promising symptom control and lower toxicity profiles in retrospective and early phase studies for head and neck cancers. However, there is a lack of prospective, randomized data directly comparing the Quad Shot regimen to the split-course approach.
This is a single-center, open-label, exploratory phase II randomized controlled trial designed to compare the efficacy, safety, and tolerability of the Quad Shot regimen versus the split-course regimen. A total of 40 adult patients will be centrally randomized in a 1:1 ratio using permuted blocks of 4, stratified by tumor volume, to receive either the experimental hypofractionated regimen or the active comparator.
To ensure data quality, the study will utilize an institutional REDCap database for electronic case report forms (eCRF) with double data entry and monthly quality control checks. Quality assurance of the radiotherapy plans will be enforced through peer review and patient-specific pre-treatment dosimetry.
A formal interim analysis for safety and futility is planned once 50% of the recruitment target is reached. Final statistical analyses will follow the Intention-To-Treat (ITT) principle. Given the palliative nature of the cohort, competitive mortality will be factored into longitudinal statistical models (such as mixed-effects models) to adequately manage missing data without distorting efficacy and quality of life estimations.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 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
- •Adult patients (>= 18 years) with a histopathological diagnosis of incurable squamous cell carcinoma of the head and neck, not candidates for curative-intent treatment.
- •Metastatic or locally advanced unresectable disease, in a strictly palliative setting.
- •Medical indication for palliative radiotherapy.
- •Performance status: Karnofsky >= 50 or ECOG <=
- •Clinical capacity to receive radiotherapy in an outpatient setting.
- •Estimated life expectancy greater than 3 months.
- •Presence of at least one measurable lesion according to RECIST 1.1 criteria.
- •Logistical capacity and willingness to adhere to follow-up clinical and radiological controls up to 6 months post-treatment.
- •Signed informed consent.
排除标准
- •History of previous radiotherapy to the same anatomical region to be treated.
- •Diagnosis of a second active malignancy that could interfere with the evaluation of oncological outcomes.
- •Presence of clinical instability or severe comorbidities that contraindicate radiotherapy treatment.
- •Severe cognitive or psychiatric alterations that prevent the understanding of the nature of the study, signing the consent form, or adherence to the protocol.
- •Women who are pregnant or breastfeeding
研究组 & 干预措施
Quad Shot Regimen
Patients assigned to this arm will receive the experimental Quad Shot hypofractionated palliative radiotherapy regimen. Treatment is delivered using Intensity-Modulated Radiation Therapy (IMRT) or Volumetric Modulated Arc Therapy (VMAT).
干预措施: Split Course Radiotherapy (Radiation)
Active Comparator: Split Course Regimen
Patients assigned to this arm will receive the standard Split Course fractionated palliative radiotherapy regimen. Treatment is delivered using Intensity-Modulated Radiation Therapy (IMRT) or Volumetric Modulated Arc Therapy (VMAT).
干预措施: Quad Shot Radiotherapy (Radiation)
结局指标
主要结局
Objective Local Tumor Response Rate Assessed by RECIST 1.1
时间窗: Exactly 3 months (12 weeks) from the date of randomization
The proportion of patients achieving an objective local tumor response, defined as either a Complete Response (CR) or a Partial Response (PR), evaluated using the Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1.
Change in Quality of Life Assessed by FACT-H&N
时间窗: Baseline, at the end of radiotherapy treatment, 3 months, and 6 months from the date of randomization
Mean change from baseline in patient-reported quality of life, measured by the Functional Assessment of Cancer Therapy-Head and Neck (FACT-H\&N) questionnaire. The FACT-H\&N assesses physical, social/family, emotional, and functional well-being, along with head and neck specific concerns. Higher scores indicate a better quality of life.
次要结局
- Incidence of Acute Treatment-Related Toxicity(From the start of treatment up to 3 months from the date of randomization)