Integrating Geriatric 8 (G8) Screening and Cancer and Age Research Group (CARG) Toxicity Assessment Score Into Routine Oncology Care for Older Adults With Cancer
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 100
- 主要终点
- Percentage of Participants With Grade 3 to 5 Chemotherapy-Related Toxicities
研究概览
简要总结
This study evaluates whether using specialized geriatric screening and toxicity prediction tools can help oncologists personalize chemotherapy dosing and reduce severe side effects in older adults with solid cancers.
Older adults with cancer have diverse levels of physical resilience and functional reserve that standard oncologic performance scores often miss. Consequently, uniform standard chemotherapy dosing can lead to severe, life-threatening toxicities, unplanned hospitalizations, or early treatment discontinuation.
In this prospective-retrospective comparative study, patients aged 65 years and older who are starting chemotherapy are prospectively evaluated using the Geriatric 8 (G8) screening tool. Patients identified as vulnerable (G8 score ≤ 14) undergo a Comprehensive Geriatric Assessment (CGA) across functional, nutritional, cognitive, and psychological domains. In addition, all prospective participants are evaluated using the Cancer and Age Research Group (CARG) toxicity tool to calculate their risk of severe side effects. Chemotherapy doses are risk-adapted based on CARG scores:
- Low Risk: Standard chemotherapy dose
- Intermediate Risk: 20% dose reduction
- High Risk: 50% dose reduction
Participants are followed every 3 months for 1 year to evaluate treatment tolerance, adherence, tumor response, and survival. These outcomes will be compared against a historical retrospective cohort of older patients with solid tumors who received standard-dose chemotherapy without G8 screening or CARG toxicity risk stratification.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Other
入排标准
- 年龄范围
- 65 Years 至 —（Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age 65 years or older
- •Confirmed diagnosis of any solid malignancy
- •Scheduled to initiate cytotoxic chemotherapy
排除标准
- •Hematological malignancies (e.g., leukemia, lymphoma)
- •Treatment plans consisting exclusively of non-chemotherapy modalities (e.g., endocrine therapy, immunotherapy monotherapy, or radiotherapy alone)
- •Incomplete or missing medical records (applicable to the retrospective historical control cohort)
研究组 & 干预措施
Prospective G8/CARG-Guided Cohort
Older adult patients (aged ≥ 65 years) with solid malignancies prospectively evaluated prior to chemotherapy using the Geriatric 8 (G8) screening tool (scores ≤ 14 trigger a Comprehensive Geriatric Assessment) and the Cancer and Age Research Group (CARG) toxicity calculator. Chemotherapy dosing is risk-adapted: standard dose for low risk (CARG 0-5), a 20% dose reduction for intermediate risk (CARG 6-9), and a 50% dose reduction for high risk (CARG ≥ 10). Patients undergo periodic clinical, geriatric, and radiological evaluations every 3 months for 1 year.
Retrospective Historical Control Cohort
A historical control cohort of older adult cancer patients (aged ≥ 65 years) with comparable solid malignancies treated with standard-dose chemotherapy prior to the institutional implementation of routine G8 screening and CARG toxicity risk assessment. Treatment-related toxicities, treatment completion, tumor response, and survival outcomes are collected retrospectively from medical records.
结局指标
主要结局
Percentage of Participants With Grade 3 to 5 Chemotherapy-Related Toxicities
时间窗: Up to 12 months
Percentage of participants who experience at least one severe, life-threatening, or fatal (Grade 3, 4, or 5) adverse event related to chemotherapy. Toxicities are evaluated according to the National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE) criteria.
次要结局
未报告次要终点
研究者
Mariam Adel Ahmed Allam
Resident of Clinical Oncology
Assiut University