Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 5:43 PM
Ignite Modification Date:
2025-12-24 @ 5:43 PM
NCT ID:
NCT02001168
Eligibility Criteria:
Inclusion Criteria:
* Patients who are diagnosed with NSCLC pathologically and T stage is T2a in postoperative pathological staging. No lymph node and distant metastasis are observed and the surgical methods include wedge incision, segmentectomy of right lung or lobe.
* Age: 18～70 years
* ECOG PS score: 0-1 score
* patients who are diagnosed with the high risk factors as follows: poor differentiation (including low differentiation, undifferentiation and neuro-endocrine differentiation), blood vessel invasion, wedge incision, tumor diameter \>4 cm, visceral pleura involvement, incomplete clear of lymph node and incisal edge \<1.0 cm.
* Patients who are diagnosed without tumor recurrence before adjuvant chemotherapy.
* Informed consent is signed.
Exclusion Criteria:
* Patients with unexpected pathological patterns or those have received new adjuvant chemotherapy.
* Patients with other active malignant tumor history beside NSCLC before treatment except non-melanoma skin cancer, primary cervical cancer and cured early prostate cancer.
* Patients who are with chemotherapeutic contraindications, such as white blood count \<4.0×109/L, blood platelet count \<80×109/L or severe anemia (Hb\<80 g/L); obvious liver dysfunction (increased transaminase or bilirubin \>2.5 folds of normal level); un-manageable hypertension, diabetes, arrhythmia, repeated heart failure and chronic obstructive pulmonary diseases that could influence ventilation function; active stage of diseases infected by bacteria, fungi and virus; or patients who are in pregnancy and lactation periods.
* Patients who are un-recovered and poor with chemotherapy after 8-week treatment, or have received above 8-week treatment before treatment.
* Patients who are in poor obedience or other improper symptoms.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
70 Years
Study:
NCT02001168
Study Brief:
Protocol Section:
NCT02001168