Application of the sG8 Scale in Real-World Geriatric Oncology Patients

N/ANot Yet RecruitingNCT06939764

Sichuan Cancer Hospital and Research Institute346 enrolled

Overview

This study is a multicenter, prospective, observational study. The study included patients aged 65 and older with solid tumors requiring systemic anti-tumor therapy. All patients underwent screening using the sG8 scale before the start of treatment, followed by routine treatment based on a plan developed through clinician decision-making. The study did not intervene in any way with the patients' diagnosis and treatment, and relevant clinical data during the treatment process were recorded accurately for follow-up patients. Study data were obtained from the electronic medical record databases and hospital information systems of multiple centers, including Sichuan Cancer Hospital. Patient clinicopathological features, pathological diagnoses, clinical stages, previous treatment histories, as well as anti-tumor treatment regimens after patient enrollment, drug dosages per cycle, treatment start times, incidence and grades of adverse events (AEs), and tumor response were extracted and collected from the medical records. All data were entered, managed, quality-controlled, exported, and analyzed through a real-world data management platform (RWDMP).

Study Type

OBSERVATIONAL

Enrollment

346

Conditions

Solid Cancers Geriatric Assessment

Interventions

Eligibility

Sex: ALLMin age: 65 Years

Medical Language ↔ Plain English

Inclusion Criteria: 1. Patients aged 65 years or older. 2. Patients with confirmed malignant tumors based on definitive pathological data. 3. Patients who are assessed by clinicians to have indications for systemic anti-tumor therapy. 4. Patients with a survival time greater than 12 weeks. Exclusion Criteria: 1. Patients who do not meet the above inclusion criteria or are considered unsuitable for this study by the investigator due to other circumstances. 2. Patients who are unwilling to cooperate in completing the sG8 scale assessment. 3. Patients who do not understand the content of this study or are unwilling to participate.

Outcomes

Primary Outcomes

The incidence of unplanned treatment delays and treatment interruptions

Time frame: From date receiving anti-tumor therapy after the first screening assessment until date of disease progression or death or the end of study, whichever came first, assessed up to 12 months

Secondary Outcomes

TRAE

Number and percentage of patents with treatment-related adverse events assessed by CTCAE v5.0.

Time frame: From date receiving anti-tumor therapy after the first screening assessment until date of disease progression or death or the end of study, whichever came first, assessed up to 12 months

ORR

the sum percentage of participants with CR and PR assessed by RECIST v1.1 criteria every 8-12 weeks.

Time frame: From date receiving anti-tumor therapy after the first screening assessment until date of disease progression or death or the end of study, whichever came first, assessed up to 12 months

PFS

Systemic Progression-Free Survival assessed by the investigators using RECIST V1.1.

Time frame: From date receiving anti-tumor therapy after the first screening assessment until date of disease progression or death or the end of study, whichever came first, assessed up to 12 months.