ID

42252

Description

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

Keywords

Versions (1)
  1. 4/20/21 4/20/21 -
Copyright Holder

GlaxoSmithKline

Uploaded on

April 20, 2021

DOI

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License

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)

English

Eligibility Criteria

1 forms  
  1. StudyEvent: ODM
    1. Eligibility Criteria
Administrative
Description

Administrative

Alias
UMLS CUI-1
C1320722
Patient Number
Description

Patient Number

Data type

text

Alias
UMLS CUI [1]
C2348585
Patient Initials
Description

Patient Initials

Data type

text

Alias
UMLS CUI [1]
C2986440
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI-1
C1512693
1. Written informed consent.
Description

1. Written informed consent.

Data type

boolean

Alias
UMLS CUI [1]
C0021430
2. Age at least 18 years old.
Description

2. Age at least 18 years old.

Data type

boolean

Alias
UMLS CUI [1]
C0001779
3. Patient has a histologically proven ED SCLC (See protocol Appendix F).
Description

3. Patient has a histologically proven ED SCLC (See protocol Appendix F).

Data type

boolean

Alias
UMLS CUI [1,1]
C0149925
UMLS CUI [1,2]
C0231449
4. Patient has had no prior chemotherapy or immunotherapy.
Description

4. Patient has had no prior chemotherapy or immunotherapy.

Data type

boolean

Alias
UMLS CUI [1]
C0392920
UMLS CUI [2]
C0021083
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.
Description

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.

Data type

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
6. It has been at least 3 weeks since any previous surgery.
Description

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).

Data type

boolean

Alias
UMLS CUI [1,1]
C0543467
UMLS CUI [1,2]
C0205156
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.
Description

Patients who have received palliative radiotherapy must have recovered from any reversible toxic effects. Permanent and stable side effects or changes are acceptable.

Data type

boolean

Alias
UMLS CUI [1]
C3898008
UMLS CUI [2]
C1522449
UMLS CUI [3]
C0280962
8. Patient has adequate bone marrow reserve, hepatic and renal function
Description

- 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.

Data type

boolean

Alias
UMLS CUI [1,1]
C0005953
UMLS CUI [1,2]
C0031843
UMLS CUI [2]
C0232804
UMLS CUI [3]
C0232741
9. Patient has an ECOG performance status of 0, 1, or 2 (see protocol Appendix C).
Description

9. Patient has an ECOG performance status of 0, 1, or 2 (see protocol Appendix C).

Data type

boolean

Alias
UMLS CUI [1]
C1520224
10. Patient has a predicted life expectancy of at least 3 months at screening.
Description

10. Patient has a predicted life expectancy of at least 3 months at screening.

Data type

boolean

Alias
UMLS CUI [1]
C0023671
UMLS CUI [2]
C0220908
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.
Description

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.

Data type

boolean

Alias
UMLS CUI [1]
C0015895
UMLS CUI [2]
C0700589
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI-1
C0680251
1. Patient is female and is pregnant or lactating.
Description

1. Patient is female and is pregnant or lactating.

Data type

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C0006147
2. Patient is of child bearing potential and is refusing to practice an effective method of contraception.
Description

2. Patient is of child bearing potential and is refusing to practice an effective method of contraception.

Data type

boolean

Alias
UMLS CUI [1]
C3831118
UMLS CUI [2]
C0700589
3. Patient has an uncontrolled infection.
Description

3. Patient has an uncontrolled infection.

Data type

boolean

Alias
UMLS CUI [1,1]
C0009450
UMLS CUI [1,2]
C0205318
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.
Description

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.

Data type

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
5. Patient has only undimensionally measurable or evaluable disease.
Description

5. Patient has only undimensionally measurable or evaluable disease.

Data type

boolean

Alias
UMLS CUI [1]
C1513041
UMLS CUI [2]
C1516986
6. Patient has clinical signs or symptoms of brain and/or leptomeningeal metastases confirmed by CT or MRI brain scan.
Description

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)

Data type

boolean

Alias
UMLS CUI [1]
C0037088
UMLS CUI [2]
C0220650
UMLS CUI [3]
C1704231
UMLS CUI [4]
C0040405
UMLS CUI [5]
C0024485
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.
Description

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.

Data type

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
8. Patient has received an investigational drug within 30 days or five half-lives prior to entry into the study (whichever is longer).
Description

8. Patient has received an investigational drug within 30 days or five half-lives prior to entry into the study (whichever is longer).

Data type

boolean

Alias
UMLS CUI [1]
C0304229
UMLS CUI [2,1]
C0008976
UMLS CUI [2,2]
C0332152
9. Patient has received other chemotherapy or immunotherapy, or concurrent radiotherapy, for the treatment of SCLC.
Description

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.

Data type

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
10. Patient has a pre-existing cardiac disease, including congestive heart failure, arrhythmia's requiring treatment, or myocardial infarction within the preceding 3 months.
Description

10. Patient has a pre-existing cardiac disease, including congestive heart failure, arrhythmia's requiring treatment, or myocardial infarction within the preceding 3 months.

Data type

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
11. Patient has any other condition for which treatment with any of the drugs used in this study are contraindicated.
Description

11. Patient has any other condition for which treatment with any of the drugs used in this study are contraindicated.

Data type

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
Inclusion/ Exclusion
Description

Inclusion/ Exclusion

Alias
UMLS CUI-1
C1512693
UMLS CUI-2
C0680251
I have assessed the patient and checked the inclusion/exclusion criteria and the patient:
Description

I have assessed the patient and checked the inclusion/exclusion criteria and the patient:

Data type

integer

Alias
UMLS CUI [1,1]
C1512693
UMLS CUI [1,2]
C0680251
Investigator's Signature
Description

Investigator's Signature

Alias
UMLS CUI-1
C2346576
Investigator's Signature
Description

Investigator's Signature

Data type

text

Alias
UMLS CUI [1]
C2346576
Investigator's Signature Date
Description

Investigator's Signature Date

Data type

date

Alias
UMLS CUI [1,1]
C2346576
UMLS CUI [1,2]
C0011008
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Similar models

Eligibility Criteria

1 forms
  1. StudyEvent: ODM
    1. Eligibility Criteria
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
Administrative
C1320722 (UMLS CUI-1)
Patient Number
Item
Patient Number
text
C2348585 (UMLS CUI [1])
Patient Initials
Item
Patient Initials
text
C2986440 (UMLS CUI [1])
Item Group
Inclusion Criteria
C1512693 (UMLS CUI-1)
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])
Item Group
Exclusion Criteria
C0680251 (UMLS CUI-1)
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 Group
Inclusion/ Exclusion
C1512693 (UMLS CUI-1)
C0680251 (UMLS CUI-2)
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])
I have assessed the patient and checked the inclusion/exclusion criteria and the patient:
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)
Item Group
Investigator's Signature
C2346576 (UMLS CUI-1)
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])
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