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Clinical effectiveness and side effects of different treatment methods for lung cancer

Observation on the clinical efficacy and side effects of EGFR-TKI ± chemotherapy in the treatment of EGFR mutation-positive advanced lung adenocarcinoma

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
ISRCTN
Registry ID
ISRCTN14796973
Enrollment
80
Registered
2022-10-22
Start date
2017-01-01
Completion date
Unknown
Last updated
2023-05-01

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

EGFR mutation-positive advanced lung adenocarcinoma Cancer

Interventions

103 EGFR mutation-positive stage IIIB or IV lung adenocarcinoma patients were enrolled in the department of oncology of Fujian Provincial Hospital from January 2017 to October 2020. According to gene

Sponsors

Fujian Provincial Hospital
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1. Initial treatment of lung adenocarcinoma confirmed by pathology or cytology 2. Classic mutation of EGFR gene 3. Minimum life expectancy 3 months 4. Patients with clinical stage III ~ IV were considered as advanced lung cancer after comprehensive evaluation of imaging, medical history and examination at the same time, and were excluded from other malignant tumors

Exclusion criteria

Exclusion criteria: Does not meet the inclusion criteria

Design outcomes

Primary

MeasureTime frame
1. Long-term efficacy: tumor progression-free survival (PFS) and survival calculated from enrollment to 1-year and 3-year follow-up 2. Adverse effects: the occurrence and severity of adverse events, including acute central nervous system adverse reactions, acute radiation pneumonia, vomiting, nausea, rash, diarrhea, liver function damage, and bone marrow suppression, using the commonly used term evaluation criterion (CTCAE4.0) of the National Cancer Center of Adverse Events and the tumor radiotherapy group (RTOG) classification standard. Calculated at 1-year and 3-year follow-up

Secondary

MeasureTime frame
1. Size and metastasis of the target tumor determined using head MRI, chest and abdomen CT (including adrenal gland), bone X-ray or MRI, or whole body PET-CT and other examinations before treatment and 12 weeks after treatment 2. Short-term efficacy: According to the WHO criteria for evaluation of solid tumor efficacy (RECIST1.1), patients were separated into progressive response (PD), stable response (SD), partial response (PR) and complete response (CR) groups. CR: indicated that all lymph nodes had shrunk to less than 10 mm and all visible lesions were cleared and maintained for at least a month; PR: the sum of the maximum diameters of all target tumors was reduced by more than 30% from baseline and remained stable for at least a month; PD: signifies that there is more than 20% growth in the sum of all target tumor maximum diameters from the minimum, and there are at least 5 mm increases in the absolute value of the maximum diameters, or that one or more new lesions emerge; SD stands for the status between PR and PD. ORR= (CR+PR)/total number of cases ×100%.

Countries

China

Contacts

Public ContactTing Li
fjslzjp@sina.com+86 (0)15711393692

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 4, 2026