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 @ 2:02 PM
Ignite Modification Date:
2025-12-24 @ 2:02 PM
NCT ID:
NCT00776295
Eligibility Criteria:
Inclusion Criteria:
* Histologically confirmed SCLC who presented with Limited Stage (LS) at diagnosis.
* Measurable disease at the time of initial therapy
* Appropriate treatment for LS-SCLC including radiotherapy and chemotherapy.
* Responsive disease to standard chemoradiation therapy as defined by RECIST
* Patients with CR after chemoradiation therapy are strongly recommended to be treated with prophylactic cranial irradiation
* CBC with an absolute neutrophil count (ANC) \>/= 1,000/uL, hemoglobin \>/= 8.0 g/DL and platelet count \>/= 75,000/uL.
* Normal prothrombin time (PT) and partial thromboplastin time (aPTT), unless on monitored anticoagulation therapy for medical conditions not excluded in the trial.
* Liver enzymes: total bilirubin less than or equal to 2mg/dL; AST and ALT less than 1.5X the upper limit of normal.
* Creatinine clearance of \>/= 60 mL/min
* Pulmonary: DLCO greater than 50%
* Cardiac: left ventricular ejection fraction greater than 45%
Exclusion Criteria:
* Patient with stable (SD) or progressive disease (PD) after 4 cycles of standard cisplatin and etoposide and concurrent chest irradiation
* Pregnant or lactating woman
* HIV infection confirmed by NAT
* Common variable immunodeficiency
* Active CNS malignancy
* Active bacterial, fungal or viral infection
* Unfavorable psychosocial evaluation or history of poor compliance to prescribed medical care
* Prior history of autologous or allogeneic hematopoietic cell transplantation
* Presence of protocol specific comorbid conditions
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT00776295
Study Brief:
Protocol Section:
NCT00776295