ID
42252
Descripción
Study ID: 104864/410 Clinical Study ID: 104864/410 Study Title: A randomised open-label multicentre Phase II study to evaluate the safety and efficacy of intravenous topotecan given with either cisplatin or etoposide every 21 days as first-line therapy in patients with extensive-disease (ED) small-cell lung cancer Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Sponsor: GlaxoSmithKline Phase: Phase 2 Study Recruitment Status: Completed Generic Name: Topotecan Study Indication: Lung Cancer
Palabras clave
Versiones (1)
- 20/4/21 20/4/21 -
Titular de derechos de autor
GlaxoSmithKline
Subido en
20 de abril de 2021
DOI
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Licencia
Creative Commons BY 4.0
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Safety and efficacy of topotecan in patients with extensive-disease small-cell lung cancer (104864/410)
Eligibility Criteria
- StudyEvent: ODM
Descripción
Inclusion Criteria
Alias
- UMLS CUI-1
- C1512693
Descripción
1. Written informed consent.
Tipo de datos
boolean
Alias
- UMLS CUI [1]
- C0021430
Descripción
2. Age at least 18 years old.
Tipo de datos
boolean
Alias
- UMLS CUI [1]
- C0001779
Descripción
3. Patient has a histologically proven ED SCLC (See protocol Appendix F).
Tipo de datos
boolean
Alias
- UMLS CUI [1,1]
- C0149925
- UMLS CUI [1,2]
- C0231449
Descripción
4. Patient has had no prior chemotherapy or immunotherapy.
Tipo de datos
boolean
Alias
- UMLS CUI [1]
- C0392920
- UMLS CUI [2]
- C0021083
Descripción
Measurable disease on CT or MRI scan must have one diameter >= 1 cm and one diameter >= 2 cm Measurable disease on chest X-ray must have both diameters >=2 cm. Palpable tumor masses that cannot be evaluated radiologically must have two diameters >= 2 cm. A measurable skin lesion must have at least one diameter >= 1 cm and it's presence must be evaluated by a photograph.
Tipo de datos
boolean
Alias
- UMLS CUI [1,1]
- C0221198
- UMLS CUI [1,2]
- C1513040
- UMLS CUI [1,3]
- C1705052
- UMLS CUI [2,1]
- C0221198
- UMLS CUI [2,2]
- C1522602
- UMLS CUI [3]
- C0040405
- UMLS CUI [4]
- C0024485
- UMLS CUI [5]
- C0031809
Descripción
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).
Tipo de datos
boolean
Alias
- UMLS CUI [1,1]
- C0543467
- UMLS CUI [1,2]
- C0205156
Descripción
Patients who have received palliative radiotherapy must have recovered from any reversible toxic effects. Permanent and stable side effects or changes are acceptable.
Tipo de datos
boolean
Alias
- UMLS CUI [1]
- C3898008
- UMLS CUI [2]
- C1522449
- UMLS CUI [3]
- C0280962
Descripción
- haemoglobin >= 9.0 g/dL (after transfusion if needed) - WBC >= 3.5 x 10^9/L - neutrophils >= 1.5 x 10^9/L - platelets >= 100 x 10^9/L - creatinine <=1.5 mg/dL (133 micromol/L) - creatinine clearance >= 60 mL/min calculated using the Cockcroft Gault formula - serum bilirubin <= 2.0 mg/dL (34 micromol/L) - SGOT/AST, SGPT/ALT, and Alkaline Phosphatase <= 2 times the upper limit of normal if liver metastases cannot be visualised by abdominal CT or MRI scan; or <= 5 times the upper limit of normal if liver metastases are present.
Tipo de datos
boolean
Alias
- UMLS CUI [1,1]
- C0005953
- UMLS CUI [1,2]
- C0031843
- UMLS CUI [2]
- C0232804
- UMLS CUI [3]
- C0232741
Descripción
9. Patient has an ECOG performance status of 0, 1, or 2 (see protocol Appendix C).
Tipo de datos
boolean
Alias
- UMLS CUI [1]
- C1520224
Descripción
10. Patient has a predicted life expectancy of at least 3 months at screening.
Tipo de datos
boolean
Alias
- UMLS CUI [1]
- C0023671
- UMLS CUI [2]
- C0220908
Descripción
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.
Tipo de datos
boolean
Alias
- UMLS CUI [1]
- C0015895
- UMLS CUI [2]
- C0700589
Descripción
Exclusion Criteria
Alias
- UMLS CUI-1
- C0680251
Descripción
1. Patient is female and is pregnant or lactating.
Tipo de datos
boolean
Alias
- UMLS CUI [1]
- C0032961
- UMLS CUI [2]
- C0006147
Descripción
2. Patient is of child bearing potential and is refusing to practice an effective method of contraception.
Tipo de datos
boolean
Alias
- UMLS CUI [1]
- C3831118
- UMLS CUI [2]
- C0700589
Descripción
3. Patient has an uncontrolled infection.
Tipo de datos
boolean
Alias
- UMLS CUI [1,1]
- C0009450
- UMLS CUI [1,2]
- C0205318
Descripción
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.
Tipo de datos
boolean
Alias
- UMLS CUI [1]
- C0006826
- UMLS CUI [2,1]
- C1515974
- UMLS CUI [2,2]
- C0205394
- UMLS CUI [3]
- C0007117
- UMLS CUI [4]
- C0007137
- UMLS CUI [5]
- C0851140
- UMLS CUI [6]
- C0280280
Descripción
5. Patient has only undimensionally measurable or evaluable disease.
Tipo de datos
boolean
Alias
- UMLS CUI [1]
- C1513041
- UMLS CUI [2]
- C1516986
Descripción
A patient with brain and/ or leptomeningeal metastases on CT or MRI scan may be included only if he/ she is asymptomatic on neurological exam and is not receiving corticosteroid therapy to control symptoms)
Tipo de datos
boolean
Alias
- UMLS CUI [1]
- C0037088
- UMLS CUI [2]
- C0220650
- UMLS CUI [3]
- C1704231
- UMLS CUI [4]
- C0040405
- UMLS CUI [5]
- C0024485
Descripción
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.
Tipo de datos
boolean
Alias
- UMLS CUI [1,1]
- C0009488
- UMLS CUI [1,2]
- C0205082
- UMLS CUI [2,1]
- C0006826
- UMLS CUI [2,2]
- C0439849
- UMLS CUI [3]
- C1321605
- UMLS CUI [4,1]
- C0205403
- UMLS CUI [4,2]
- C0035647
- UMLS CUI [5,1]
- C0023671
- UMLS CUI [5,2]
- C0547047
Descripción
8. Patient has received an investigational drug within 30 days or five half-lives prior to entry into the study (whichever is longer).
Tipo de datos
boolean
Alias
- UMLS CUI [1]
- C0304229
- UMLS CUI [2,1]
- C0008976
- UMLS CUI [2,2]
- C0332152
Descripción
Radiotherapy may be given concomitantly for the palliative control of bone pain, however not all measurable or evaluable lesions should be included in the irradiated field.
Tipo de datos
boolean
Alias
- UMLS CUI [1,1]
- C3665472
- UMLS CUI [1,2]
- C0205394
- UMLS CUI [2,1]
- C0021083
- UMLS CUI [2,2]
- C0205394
- UMLS CUI [3]
- C0149925
Descripción
10. Patient has a pre-existing cardiac disease, including congestive heart failure, arrhythmia's requiring treatment, or myocardial infarction within the preceding 3 months.
Tipo de datos
boolean
Alias
- UMLS CUI [1,1]
- C0018799
- UMLS CUI [1,2]
- C2347662
- UMLS CUI [2]
- C0018802
- UMLS CUI [3,1]
- C0003811
- UMLS CUI [3,2]
- C0087111
- UMLS CUI [4]
- C0027051
Descripción
11. Patient has any other condition for which treatment with any of the drugs used in this study are contraindicated.
Tipo de datos
boolean
Alias
- UMLS CUI [1,1]
- C0012634
- UMLS CUI [1,2]
- C0205394
- UMLS CUI [2,1]
- C0087111
- UMLS CUI [2,2]
- C0013227
- UMLS CUI [3]
- C1301624
Descripción
Inclusion/ Exclusion
Alias
- UMLS CUI-1
- C1512693
- UMLS CUI-2
- C0680251
Descripción
Investigator's Signature
Alias
- UMLS CUI-1
- C2346576
Similar models
Eligibility Criteria
- StudyEvent: ODM
C0231449 (UMLS CUI [1,2])
C0021083 (UMLS CUI [2])
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])
C0205156 (UMLS CUI [1,2])
C1522449 (UMLS CUI [2])
C0280962 (UMLS CUI [3])
C0031843 (UMLS CUI [1,2])
C0232804 (UMLS CUI [2])
C0232741 (UMLS CUI [3])
C0220908 (UMLS CUI [2])
C0700589 (UMLS CUI [2])
C0006147 (UMLS CUI [2])
C0700589 (UMLS CUI [2])
C0205318 (UMLS CUI [1,2])
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])
C1516986 (UMLS CUI [2])
C0220650 (UMLS CUI [2])
C1704231 (UMLS CUI [3])
C0040405 (UMLS CUI [4])
C0024485 (UMLS CUI [5])
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])
C0008976 (UMLS CUI [2,1])
C0332152 (UMLS CUI [2,2])
C0205394 (UMLS CUI [1,2])
C0021083 (UMLS CUI [2,1])
C0205394 (UMLS CUI [2,2])
C0149925 (UMLS CUI [3])
C2347662 (UMLS CUI [1,2])
C0018802 (UMLS CUI [2])
C0003811 (UMLS CUI [3,1])
C0087111 (UMLS CUI [3,2])
C0027051 (UMLS CUI [4])
C0205394 (UMLS CUI [1,2])
C0087111 (UMLS CUI [2,1])
C0013227 (UMLS CUI [2,2])
C1301624 (UMLS CUI [3])
C0680251 (UMLS CUI [1,2])
C0011008 (UMLS CUI [1,2])