Prospectively observational study to closely monitor the disease progression pattern in postoperative recurrent oligo metastatic EGFR-mutant lung cancer patients
- Conditions
- Neoplasms
- Registration Number
- KCT0007291
- Lead Sponsor
- ational Cancer Center
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- 20
1) 19 years of age or older
2) Cytologically or histologically proven non-small cell lung cancer
3) Based on the 8th edition of AJCC-TNM, after being diagnosed with stage IA to IIIA non-small cell lung cancer, undergoing curative surgery, and recovering, recurrence of small metastases must be confirmed by imaging
Limited to small intrathoracic metastases: There should be a maximum of 5 metastatic lesions and there should be no symptoms due to the sum of the long axes of the target lesions being less than 5 cm. The lesion is confined to the thoracic region (lung, lymph node, pleura, etc.).
4) No previous systemic chemotherapy for recurrent tumors.
5) When systemic recurrence is confirmed, it should not be subjected to surgery or radiation therapy.
6) Must have measurable lesions.
7) Patients in which the presence of a well-known sensitizing EGFR mutation (exon 19 deletion or exon 21 L858R, exon G719X, etc.) well-known by tissue sequencing method was detected in an accredited laboratory
8) Daily Performance Scale ECOG (Eastern Cooperative Oncology Group) 0, 1, 2
9) After hearing the explanation before the test, the subject or the subject's representative voluntarily gave written consent.
10) Agree to genetic testing and research on human materials
1) Received chemotherapy, surgery, or radiation therapy within 3 weeks prior to study participation.
2) Active brain or meningeal metastases with clinically significant neurological symptoms or signs. (unless there are no clinically significant neurological symptoms or signs and steroids are not required).
3) History of other malignant diseases (except cured non-melanoma skin cancer, cervical carcinoma in situ, superficial bladder cancer, thyroid cancer). However, unless there is no ongoing treatment within the past 3 years, or if there is no evidence of recurrence or recurrence, there is no clear cure.
4) When the judges that the administration of the test drug is difficult due to the toxicity of the previous treatment
5) Administered other investigational drugs within 4 weeks prior to enrollment in this study
Study & Design
- Study Type
- Observational Study
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method survival period
- Secondary Outcome Measures
Name Time Method Progression Free Survival;Tumor response assessment (CR+PR by RECIST1.1);Quality of Life Assessment;Safety assessment