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:
2025-12-25 @ 2:09 AM
Ignite Modification Date:
2025-12-25 @ 2:09 AM
NCT ID:
NCT01656460
Eligibility Criteria:
PATIENT ELIGIBILITY Conditions for Patient Eligibility (Inclusion)
* Pathologically or cytologically confirmed NSCLC
* Stage III NSCLC according to the AJCC 7th edition staging criteria. Stage II (T1-3N1) patient that are deemed medically inoperable are also eligible.
* Concurrent chemoradiation to a radiation dose of 50.4 Gy.
* residual tumor volume after concurrent chemoradiation that is appropriate for SBRT:
* Primary tumor \<120cc (approximately 6cm diameter).
* Mediastinal/Hilar disease: 1-2 involved regions \<60cc (approximately 5cmx3cmx3cm)
* Absolute neutrophil count ≥ 1,000/uL, platelet ≥ 60,000/uL.
* Total bilirubin ≤ 2x upper institutional limit of normal (ULN), and AST or ALT ≤5x ULN.
* ECOG performance status 0 to 2
* Minimum life expectancy of 12 weeks.
* Age older than 18 years.
* Voluntary, signed written informed consent.
* Women of childbearing potential must have a negative pregnancy test
* Men and women of childbearing potential must be willing to consent to using effective contraception while on treatment and for at least 1 months thereafter.
Conditions for Patient Ineligibility (Exclusion)
* Disease progression during or after standard chemoradiation to 50.4 Gy
* Prior thoracic radiation other than the pre-operative radiation not greater than 50.4
* Metastatic disease
* Uncontrolled severe, intercurrent illness.
* Women who are breast-feeding.
* No chemotherapy within 2 weeks from the first SBRT treatment.
* Concurrent anticancer therapy.
* Prior complete resection of all NSCLC.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT01656460
Study Brief:
Protocol Section:
NCT01656460