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 @ 2:52 PM
Ignite Modification Date:
2025-12-24 @ 2:52 PM
NCT ID:
NCT01797159
Eligibility Criteria:
Inclusion Criteria:
* Patient must have newly diagnosed and confirmed small-cell lung cancer (SCLC)
* Patient must have a performance status of 1 or higher
* Patients must not have received previous irradiation to the brain
* Patients must have limited stage disease with complete response to chemotherapy and consolidative chest radiotherapy that was documented at least on standard chest x-rays within one month of study entry
* Negative MRI or CT scan of the brain at least one month before protocol entry
* Women of child-bearing potential must have a negative pregnancy test and also agree to use adequate contraceptives while on protocol
* Patient must be able to understand and sign the informed consent document
* Patient must be informed of the investigational aspect to this trial prior to singing the informed consent document
Exclusion Criteria:
* Patients receiving prior external beam irradiation to the head or neck, including any form of stereotactic irradiation
* Radiographic evidence of brain metastases and/or ipsilateral lung metastases/malignant pleural effusion
* Planned concurrent chemotherapy or antitumoral agent during PCI
* Concomitant malignancy or malignancy within the past five years other than nonmelanomatous skin cancer or carcinoma in situ of the cervix
* Patients with minimal pleural effusion evident on chest X-ray; minimal pleural effusion visible on chest CT is allowed.
* Patients with epilepsy requiring permanent oral medication
* Patients must not have a serious medical or psychiatric illness that would, in the opinion of the investigator, prevent informed consent or completion of protocol treatment, and/or follow-up visits.
* Patients may not take Memantine. This is the only eligibility criterion that has been added to those of RTOG 0212, since some physicians might now prescribe Memantine. This medication would not have been given at the time of enrollment on RTOG 0212 and its administration could confound the results of this study.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
100 Years
Study:
NCT01797159
Study Brief:
Protocol Section:
NCT01797159