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 @ 7:23 PM
Ignite Modification Date:
2025-12-24 @ 7:23 PM
NCT ID:
NCT03214003
Eligibility Criteria:
Inclusion Criteria:
* Read the patient information and Sign the informed consent before enrollment
* Either sex, age ≥18 and ≤70
* Histologically or cytologically confirmed SLCL
* Limited stage disease(AJCC, 2009 version 7), stage I-III(T any, N any, M0) that can be safely treated with definitive radiation doses, excludes T3-4 due to multiple lung nodules that are too extensive or have tumor/nodal volume that is too large to be encompassed in a tolerable radiation plan, clinical nonmalignant diagnosis by investigator when the pleural is too few to obtain cytological evidence.
* measurable lesion according RECIST 1.1
* PS ECOG 0-1
* having zero to two cycles of systemic chemotherapy with etoposide and cisplatin (cisplatin 60-80 mg/m2 at day1 or divided into two to three days, etoposide 100-120 mg/m2 at day 1 to 3, Q21d, and the treatment delay between two cycles shouldn't be more than 14days).
* patients especially female patients must satisfy the investigator that they are not pregnant, or are not of childbearing potential, or are using adequate contraception. Man must also use adequate contraception
* adequate haematological function: white blood cell ≥3.0×109/L , neutrophils ≥1.5×109/L, platelet ≥100×109/L, hemoglobin ≥90g/L.
* adequate liver and renal function: total bilirubin ≤1.5 ×upper limit normal , alanine transaminase and aspartate aminotransferase ≤1.5 ×upper limit normal, normal serum creatinine and/or calculated creatinine clearance ≥60ml/min.
Exclusion Criteria:
* prior surgical resection of the primary tumor or prior RT for lung cancer
* mixed small-cell and non-small-cell histological features
* contemporaneous immunotherapy or target therapy
* pregnancy or lactation
* physical or mental disease that could impact treatment plan
* unable to understand the trial, or could not follow the process
* to refuse the sign the informed consent.
* no history of previous malignancy in the past 5 years (except non-melanomatous skin or in situ servix carcinoma)
* be allergic to any known protocol in this trail
* be enrolled in other clinical trial in past 30days
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
70 Years
Study:
NCT03214003
Study Brief:
Protocol Section:
NCT03214003