Non-Small Cell Lung Carcinoma | Chemotherapy Disease | Biological Response Modifier Therapy Disease
Item
1. patients must have a histologically or cytologically confirmed diagnosis of nsclc and must not have had chemotherapy or biological therapy for their disease.
boolean
C0007131 (UMLS CUI [1])
C0392920 (UMLS CUI [2,1])
C0012634 (UMLS CUI [2,2])
C0005527 (UMLS CUI [3,1])
C0012634 (UMLS CUI [3,2])
TNM clinical staging | Pleural effusion disorder | Pericardial effusion | Disease Amenable Operative Surgical Procedures | Disease Amenable Therapeutic radiology procedure Curative intent
Item
2. stage iiib (n3 and/or pleural or pericardial effusion) or iv disease that is not amenable to either surgery or radiation therapy of curative intent.
boolean
C3258246 (UMLS CUI [1])
C0032227 (UMLS CUI [2])
C0031039 (UMLS CUI [3])
C0012634 (UMLS CUI [4,1])
C3900053 (UMLS CUI [4,2])
C0543467 (UMLS CUI [4,3])
C0012634 (UMLS CUI [5,1])
C3900053 (UMLS CUI [5,2])
C1522449 (UMLS CUI [5,3])
C1276305 (UMLS CUI [5,4])
Life Expectancy
Item
3. life expectancy of ≥ 12 weeks
boolean
C0023671 (UMLS CUI [1])
prior radiation therapy | Therapeutic radiology procedure Lesion | Lesion Use of Evaluating response to treatment | Lesion Increased size | Toxic effect Due to Therapeutic radiology procedure | Patient Recovered
Item
4. if patient has had prior radiation therapy: lesion(s) used for determination of response was not previously irradiated or has increased in size since the completion of radiotherapy; and patient has recovered from any toxicity from the radiotherapy.
boolean
C0279134 (UMLS CUI [1])
C1522449 (UMLS CUI [2,1])
C0221198 (UMLS CUI [2,2])
C0221198 (UMLS CUI [3,1])
C1524063 (UMLS CUI [3,2])
C0184781 (UMLS CUI [3,3])
C0221198 (UMLS CUI [4,1])
C0332509 (UMLS CUI [4,2])
C0600688 (UMLS CUI [5,1])
C0678226 (UMLS CUI [5,2])
C1522449 (UMLS CUI [5,3])
C0030705 (UMLS CUI [6,1])
C0521108 (UMLS CUI [6,2])
Therapeutic radiology procedure Completed Lesion Quantity | Evaluating response to treatment | Therapeutic radiology procedure Completed Site
Item
5. radiotherapy to lesion(s) used for determination of response was completed at least 6 weeks prior to treatment; radiotherapy to other sites was completed at least 2 weeks prior to treatment.
boolean
C1522449 (UMLS CUI [1,1])
C0205197 (UMLS CUI [1,2])
C0221198 (UMLS CUI [1,3])
C1265611 (UMLS CUI [1,4])
C0184781 (UMLS CUI [2])
C1522449 (UMLS CUI [3,1])
C0205197 (UMLS CUI [3,2])
C1515974 (UMLS CUI [3,3])
Measurable Disease Linear Quantity | Measurable Disease Longest Diameter | Tomography, Spiral Computed | Measurement technique Standard
Item
6. at least one unidimensionally measurable lesion meeting response evaluation criteria in solid tumors [recist] (at least 10 mm in longest diameter by spiral computed tomography [ct] scan, or at least 20 mm by standard techniques).
boolean
C1513041 (UMLS CUI [1,1])
C0205132 (UMLS CUI [1,2])
C1265611 (UMLS CUI [1,3])
C1513041 (UMLS CUI [2,1])
C0552406 (UMLS CUI [2,2])
C0860888 (UMLS CUI [3])
C0242485 (UMLS CUI [4,1])
C1442989 (UMLS CUI [4,2])
ECOG performance status
Item
7. ecog status must be ≤ 1
boolean
C1520224 (UMLS CUI [1])
Prior Chemotherapy Non-Small Cell Lung Carcinoma | Biological Response Modifier Therapy Approved Non-Small Cell Lung Carcinoma | Biological Response Modifier Therapy Investigational Non-Small Cell Lung Carcinoma | Adjuvant therapy Non-Small Cell Lung Carcinoma | Neoadjuvant Therapy Non-Small Cell Lung Carcinoma
Item
1. prior chemotherapy or biological therapy (approved or experimental) for nsclc, including adjuvant and neoadjuvant treatment.
boolean
C1514457 (UMLS CUI [1,1])
C0007131 (UMLS CUI [1,2])
C0005527 (UMLS CUI [2,1])
C0205540 (UMLS CUI [2,2])
C0007131 (UMLS CUI [2,3])
C0005527 (UMLS CUI [3,1])
C1517586 (UMLS CUI [3,2])
C0007131 (UMLS CUI [3,3])
C0677850 (UMLS CUI [4,1])
C0007131 (UMLS CUI [4,2])
C0600558 (UMLS CUI [5,1])
C0007131 (UMLS CUI [5,2])
CNS metastases | Local Therapy Completed CNS metastases | Leptomeningeal disease | Adrenal Cortex Hormones Discontinued
Item
2. presence of central nervous system (cns) metastases, unless the patient has completed successful local therapy for cns metastases, with the exception of leptomeningeal disease for which patients will be excluded. patients must be off corticosteroids for at least 21 days prior to starting treatment.
boolean
C0686377 (UMLS CUI [1])
C1517925 (UMLS CUI [2,1])
C0205197 (UMLS CUI [2,2])
C0686377 (UMLS CUI [2,3])
C3160796 (UMLS CUI [3])
C0001617 (UMLS CUI [4,1])
C1444662 (UMLS CUI [4,2])
Second Primary Cancer | Carcinoma in situ of uterine cervix | Skin carcinoma Treated | Malignant neoplasm of prostate Localized Clinical | Carcinoma of urinary bladder, superficial | Malignant Neoplasm Treated | Recurrence Evidence
Item
3. second primary malignancy (except in situ carcinoma of the cervix, adequately treated non-melanomatous skin cancers, clinically localized prostate cancer, superficial bladder cancer or other malignancy treated at least 3 years previously with no evidence of recurrence).
boolean
C0751623 (UMLS CUI [1])
C0851140 (UMLS CUI [2])
C0699893 (UMLS CUI [3,1])
C1522326 (UMLS CUI [3,2])
C0376358 (UMLS CUI [4,1])
C0392752 (UMLS CUI [4,2])
C0205210 (UMLS CUI [4,3])
C1336527 (UMLS CUI [5])
C0006826 (UMLS CUI [6,1])
C1522326 (UMLS CUI [6,2])
C2825055 (UMLS CUI [7,1])
C3887511 (UMLS CUI [7,2])
Indication Combined Modality Therapy Curative intent | Chemotherapy | Therapeutic radiology procedure | Operative Surgical Procedures | TNM clinical staging
Item
4. patients eligible for combined modality therapy with curative intent as defined by the combination of chemotherapy, radiation therapy and/or surgery. (this criteria is intended to exclude patients with stage iiib disease, as defined by the presence of n3 nodal status, who have been reported to have cure rates as high as 10% when treated with combined modality therapy.)
boolean
C3146298 (UMLS CUI [1,1])
C0009429 (UMLS CUI [1,2])
C1276305 (UMLS CUI [1,3])
C0392920 (UMLS CUI [2])
C1522449 (UMLS CUI [3])
C0543467 (UMLS CUI [4])
C3258246 (UMLS CUI [5])