1. Written informed consent.
Item
1. Written informed consent.
boolean
C0021430 (UMLS CUI [1])
2. Age at least 18 years old.
Item
2. Age at least 18 years old.
boolean
C0001779 (UMLS CUI [1])
3. Patient has a histologically proven ED SCLC (See protocol Appendix F).
Item
3. Patient has a histologically proven ED SCLC (See protocol Appendix F).
boolean
C0149925 (UMLS CUI [1,1])
C0231449 (UMLS CUI [1,2])
4. Patient has had no prior chemotherapy or immunotherapy.
Item
4. Patient has had no prior chemotherapy or immunotherapy.
boolean
C0392920 (UMLS CUI [1])
C0021083 (UMLS CUI [2])
5. Patient has a presence of at least one bidimensionally measurable, non-CNS lesion (indicator lesion) defined by diagnostic studies including CT or MRI scan, chest X-ray or physical examination.
Item
5. Patient has a presence of at least one bidimensionally measurable, non-CNS lesion (indicator lesion) defined by diagnostic studies including CT or MRI scan, chest X-ray or physical examination.
boolean
C0221198 (UMLS CUI [1,1])
C1513040 (UMLS CUI [1,2])
C1705052 (UMLS CUI [1,3])
C0221198 (UMLS CUI [2,1])
C1522602 (UMLS CUI [2,2])
C0040405 (UMLS CUI [3])
C0024485 (UMLS CUI [4])
C0031809 (UMLS CUI [5])
6. It has been at least 3 weeks since any previous surgery (a lesser period is acceptable if deemed in the best interest of the patient).
Item
6. It has been at least 3 weeks since any previous surgery.
boolean
C0543467 (UMLS CUI [1,1])
C0205156 (UMLS CUI [1,2])
7. It has been at least 24 hours since any palliative radiotherapy and the extent and site of radiotherapy fields are such that marked bone marrow suppression is not expected.
Item
7. It has been at least 24 hours since any palliative radiotherapy and the extent and site of radiotherapy fields are such that marked bone marrow suppression is not expected.
boolean
C3898008 (UMLS CUI [1])
C1522449 (UMLS CUI [2])
C0280962 (UMLS CUI [3])
8. Patient has adequate bone marrow reserve, hepatic and renal function
Item
8. Patient has adequate bone marrow reserve, hepatic and renal function
boolean
C0005953 (UMLS CUI [1,1])
C0031843 (UMLS CUI [1,2])
C0232804 (UMLS CUI [2])
C0232741 (UMLS CUI [3])
9. Patient has an ECOG performance status of 0, 1, or 2 (see protocol Appendix C).
Item
9. Patient has an ECOG performance status of 0, 1, or 2 (see protocol Appendix C).
boolean
C1520224 (UMLS CUI [1])
10. Patient has a predicted life expectancy of at least 3 months at screening.
Item
10. Patient has a predicted life expectancy of at least 3 months at screening.
boolean
C0023671 (UMLS CUI [1])
C0220908 (UMLS CUI [2])
11. Patient is not of reproductive potential, or if the patient is of reproductive potential the patient agrees to practice an effective method of contraception.
Item
11. Patient is not of reproductive potential, or if the patient is of reproductive potential the patient agrees to practice an effective method of contraception.
boolean
C0015895 (UMLS CUI [1])
C0700589 (UMLS CUI [2])
1. Patient is female and is pregnant or lactating.
Item
1. Patient is female and is pregnant or lactating.
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
2. Patient is of child bearing potential and is refusing to practice an effective method of contraception.
Item
2. Patient is of child bearing potential and is refusing to practice an effective method of contraception.
boolean
C3831118 (UMLS CUI [1])
C0700589 (UMLS CUI [2])
3. Patient has an uncontrolled infection.
Item
3. Patient has an uncontrolled infection.
boolean
C0009450 (UMLS CUI [1,1])
C0205318 (UMLS CUI [1,2])
4. Patient has previous or concomitant malignancies at other sites within the last 5 years excepting basal or squamous cell carcinoma of the skin and carcinoma in situ of the cervix or stage A low grade prostate cancer.
Item
4. Patient has previous or concomitant malignancies at other sites within the last 5 years excepting basal or squamous cell carcinoma of the skin and carcinoma in situ of the cervix or stage A low grade prostate cancer.
boolean
C0006826 (UMLS CUI [1])
C1515974 (UMLS CUI [2,1])
C0205394 (UMLS CUI [2,2])
C0007117 (UMLS CUI [3])
C0007137 (UMLS CUI [4])
C0851140 (UMLS CUI [5])
C0280280 (UMLS CUI [6])
5. Patient has only undimensionally measurable or evaluable disease.
Item
5. Patient has only undimensionally measurable or evaluable disease.
boolean
C1513041 (UMLS CUI [1])
C1516986 (UMLS CUI [2])
6. Patient has clinical signs or symptoms of brain and/or leptomeningeal metastases confirmed by CT or MRI brain scan.
Item
6. Patient has clinical signs or symptoms of brain and/or leptomeningeal metastases confirmed by CT or MRI brain scan.
boolean
C0037088 (UMLS CUI [1])
C0220650 (UMLS CUI [2])
C1704231 (UMLS CUI [3])
C0040405 (UMLS CUI [4])
C0024485 (UMLS CUI [5])
7. Patient has concurrent severe medical problems unrelated to the malignancy which would significantly limit full compliance with the study or expose the patient to extreme risk or decreased life expectancy.
Item
7. Patient has concurrent severe medical problems unrelated to the malignancy which would significantly limit full compliance with the study or expose the patient to extreme risk or decreased life expectancy.
boolean
C0009488 (UMLS CUI [1,1])
C0205082 (UMLS CUI [1,2])
C0006826 (UMLS CUI [2,1])
C0439849 (UMLS CUI [2,2])
C1321605 (UMLS CUI [3])
C0205403 (UMLS CUI [4,1])
C0035647 (UMLS CUI [4,2])
C0023671 (UMLS CUI [5,1])
C0547047 (UMLS CUI [5,2])
8. Patient has received an investigational drug within 30 days or five half-lives prior to entry into the study (whichever is longer).
Item
8. Patient has received an investigational drug within 30 days or five half-lives prior to entry into the study (whichever is longer).
boolean
C0304229 (UMLS CUI [1])
C0008976 (UMLS CUI [2,1])
C0332152 (UMLS CUI [2,2])
9. Patient has received other chemotherapy or immunotherapy, or concurrent radiotherapy, for the treatment of SCLC.
Item
9. Patient has received other chemotherapy or immunotherapy, or concurrent radiotherapy, for the treatment of SCLC.
boolean
C3665472 (UMLS CUI [1,1])
C0205394 (UMLS CUI [1,2])
C0021083 (UMLS CUI [2,1])
C0205394 (UMLS CUI [2,2])
C0149925 (UMLS CUI [3])
10. Patient has a pre-existing cardiac disease, including congestive heart failure, arrhythmia's requiring treatment, or myocardial infarction within the preceding 3 months.
Item
10. Patient has a pre-existing cardiac disease, including congestive heart failure, arrhythmia's requiring treatment, or myocardial infarction within the preceding 3 months.
boolean
C0018799 (UMLS CUI [1,1])
C2347662 (UMLS CUI [1,2])
C0018802 (UMLS CUI [2])
C0003811 (UMLS CUI [3,1])
C0087111 (UMLS CUI [3,2])
C0027051 (UMLS CUI [4])
11. Patient has any other condition for which treatment with any of the drugs used in this study are contraindicated.
Item
11. Patient has any other condition for which treatment with any of the drugs used in this study are contraindicated.
boolean
C0012634 (UMLS CUI [1,1])
C0205394 (UMLS CUI [1,2])
C0087111 (UMLS CUI [2,1])
C0013227 (UMLS CUI [2,2])
C1301624 (UMLS CUI [3])
Item
I have assessed the patient and checked the inclusion/exclusion criteria and the patient:
integer
C1512693 (UMLS CUI [1,1])
C0680251 (UMLS CUI [1,2])
Code List
I have assessed the patient and checked the inclusion/exclusion criteria and the patient:
CL Item
Is eligible to participate in the study. (1)
CL Item
Is not eligible to participate in the study. (2)
Investigator's Signature
Item
Investigator's Signature
text
C2346576 (UMLS CUI [1])
Investigator's Signature Date
Item
Investigator's Signature Date
date
C2346576 (UMLS CUI [1,1])
C0011008 (UMLS CUI [1,2])