ID
37677
Description
Study ID: 104864/517 Clinical Study ID: 104864/517 Study Title: A Phase I Study of Oral Topotecan as a Radiosensitizing Agent in Patients With Rectal Cancer Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT00158886 Sponsor: GlaxoSmithKline Collaborators: N/A Phase: Phase 1 Study Recruitment Status: Completed Generic Name: Topotecan + Radiation therapy Trade Name: N/A Study Indication: Rectal Cancer, Carcinoma, Renal Cell
Keywords
Versions (1)
- 8/16/19 8/16/19 -
Copyright Holder
GlaxoSmithKline
Uploaded on
August 16, 2019
DOI
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License
Creative Commons BY-NC 3.0
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Oral Topotecan as Radiosensitizing Agent in Patients with Rectal Cancer; NCT00158886
Screening
- StudyEvent: ODM
Description
Demography
Alias
- UMLS CUI-1
- C0011298
Description
Vital Signs
Alias
- UMLS CUI-1
- C0518766
Description
Body Height, Unit of Measure
Data type
text
Alias
- UMLS CUI [1,1]
- C0005890
- UMLS CUI [1,2]
- C1519795
Description
Body Height
Data type
float
Alias
- UMLS CUI [1]
- C0005890
Description
Body Weight, Unit of Measure
Data type
text
Alias
- UMLS CUI [1,1]
- C0005910
- UMLS CUI [1,2]
- C1519795
Description
Body Weight
Data type
float
Alias
- UMLS CUI [1]
- C0005910
Description
Body temperature measurement site
Data type
text
Alias
- UMLS CUI [1]
- C0489453
Description
Body Temperature, Unit of Measure
Data type
text
Alias
- UMLS CUI [1,1]
- C0005903
- UMLS CUI [1,2]
- C1519795
Description
Body Temperature
Data type
float
Alias
- UMLS CUI [1]
- C0005903
Description
Systolic Pressure, Sitting position
Data type
integer
Measurement units
- mmHg
Alias
- UMLS CUI [1,1]
- C0871470
- UMLS CUI [1,2]
- C0277814
Description
Diastolic blood pressure, Sitting position
Data type
integer
Measurement units
- mmHg
Alias
- UMLS CUI [1,1]
- C0428883
- UMLS CUI [1,2]
- C0277814
Description
Heart rate, Sitting position
Data type
integer
Measurement units
- bpm
Alias
- UMLS CUI [1,1]
- C0018810
- UMLS CUI [1,2]
- C0277814
Description
History of Rectal Carcinoma
Alias
- UMLS CUI-1
- C0007113
- UMLS CUI-2
- C0262926
Description
Rectal Carcinoma, Primary Disorders, Date of diagnosis
Data type
date
Alias
- UMLS CUI [1,1]
- C0007113
- UMLS CUI [1,2]
- C0277554
- UMLS CUI [1,3]
- C2316983
Description
Rectal Carcinoma, TNM clinical staging, primary tumor
Data type
text
Alias
- UMLS CUI [1,1]
- C0007113
- UMLS CUI [1,2]
- C3258246
- UMLS CUI [1,3]
- C0677930
Description
Rectal Carcinoma, TNM clinical staging, Lymph nodes
Data type
text
Alias
- UMLS CUI [1,1]
- C0007113
- UMLS CUI [1,2]
- C3258246
- UMLS CUI [1,3]
- C0024204
Description
Rectal Carcinoma, TNM clinical staging, Neoplasm Metastasis
Data type
text
Alias
- UMLS CUI [1,1]
- C0007113
- UMLS CUI [1,2]
- C3258246
- UMLS CUI [1,3]
- C0027627
Description
Rectal Carcinoma, Tumor Size, Height
Data type
float
Measurement units
- cm
Alias
- UMLS CUI [1,1]
- C0007113
- UMLS CUI [1,2]
- C0475440
- UMLS CUI [1,3]
- C0489786
Description
Rectal Carcinoma, Tumor Size, Width
Data type
float
Measurement units
- cm
Alias
- UMLS CUI [1,1]
- C0007113
- UMLS CUI [1,2]
- C0475440
- UMLS CUI [1,3]
- C0487742
Description
Rectal Carcinoma, Tumor Size, Diameter
Data type
float
Measurement units
- cm
Alias
- UMLS CUI [1,1]
- C0007113
- UMLS CUI [1,2]
- C0475440
- UMLS CUI [1,3]
- C1301886
Description
Rectal Carcinoma, Ulceration
Data type
boolean
Alias
- UMLS CUI [1,1]
- C0007113
- UMLS CUI [1,2]
- C3887532
Description
Rectal Carcinoma, Fixation
Data type
boolean
Alias
- UMLS CUI [1,1]
- C0007113
- UMLS CUI [1,2]
- C0185023
Description
Previous Surgical Procedures for Rectal Carcinoma
Alias
- UMLS CUI-1
- C0007113
- UMLS CUI-2
- C0543467
- UMLS CUI-3
- C0205156
Description
Rectal Carcinoma, Operative Surgical Procedures, Previous
Data type
boolean
Alias
- UMLS CUI [1,1]
- C0007113
- UMLS CUI [1,2]
- C0543467
- UMLS CUI [1,3]
- C0205156
Description
Rectal Carcinoma, Operative Surgical Procedures, Previous
Data type
text
Alias
- UMLS CUI [1,1]
- C0007113
- UMLS CUI [1,2]
- C0543467
- UMLS CUI [1,3]
- C0205156
Description
Rectal Carcinoma, Operative Surgical Procedures, Date in time
Data type
text
Alias
- UMLS CUI [1,1]
- C0007113
- UMLS CUI [1,2]
- C0543467
- UMLS CUI [1,3]
- C0011008
Description
12-Lead Electrocardiogram
Alias
- UMLS CUI-1
- C0430456
Description
Diagnostic Studies for Tumor Assessment
Alias
- UMLS CUI-1
- C0007113
- UMLS CUI-2
- C0220825
- UMLS CUI-3
- C0430022
Description
Rectal Carcinoma, Evaluation, Diagnostic procedure
Data type
text
Alias
- UMLS CUI [1,1]
- C0007113
- UMLS CUI [1,2]
- C0220825
- UMLS CUI [1,3]
- C0430022
Description
Rectal Carcinoma, Evaluation, Diagnostic procedure, Date in time
Data type
date
Alias
- UMLS CUI [1,1]
- C0007113
- UMLS CUI [1,2]
- C0220825
- UMLS CUI [1,3]
- C0430022
- UMLS CUI [1,4]
- C0011008
Description
Rectal Carcinoma, Evaluation, Diagnostic procedure, Clinical Significance
Data type
text
Alias
- UMLS CUI [1,1]
- C0007113
- UMLS CUI [1,2]
- C0220825
- UMLS CUI [1,3]
- C0430022
- UMLS CUI [1,4]
- C2826293
Description
Rectal Carcinoma, Evaluation, Diagnostic procedure, Not Done
Data type
boolean
Alias
- UMLS CUI [1,1]
- C0007113
- UMLS CUI [1,2]
- C0220825
- UMLS CUI [1,3]
- C0430022
- UMLS CUI [1,4]
- C1272696
Description
Ongoing Medical Conditions Associated with Rectal Carcinoma
Alias
- UMLS CUI-1
- C0012634
- UMLS CUI-2
- C0439849
- UMLS CUI-3
- C0007113
Description
Disease, Relationships, Rectal Carcinoma
Data type
boolean
Alias
- UMLS CUI [1,1]
- C0012634
- UMLS CUI [1,2]
- C0439849
- UMLS CUI [1,3]
- C0007113
Description
Disease, Relationships, Rectal Carcinoma
Data type
text
Alias
- UMLS CUI [1,1]
- C0012634
- UMLS CUI [1,2]
- C0439849
- UMLS CUI [1,3]
- C0007113
Description
Disease, Relationships, Rectal Carcinoma, National Cancer Institute common terminology criteria for adverse event grade finding
Data type
text
Alias
- UMLS CUI [1,1]
- C0012634
- UMLS CUI [1,2]
- C0439849
- UMLS CUI [1,3]
- C0007113
- UMLS CUI [1,4]
- C3887242
Description
Disease, Relationships, Rectal Carcinoma, Date of diagnosis
Data type
integer
Alias
- UMLS CUI [1,1]
- C0012634
- UMLS CUI [1,2]
- C0439849
- UMLS CUI [1,3]
- C0007113
- UMLS CUI [1,4]
- C2316983
Description
Significant Medical/Surgical History and Physical Examination
Alias
- UMLS CUI-1
- C0262926
- UMLS CUI-2
- C0489540
- UMLS CUI-3
- C0031809
Description
Medical History; History of surgical procedures
Data type
boolean
Alias
- UMLS CUI [1]
- C0262926
- UMLS CUI [2]
- C0489540
Description
Medical History, Diagnosis; History of surgical procedures, Diagnosis
Data type
text
Alias
- UMLS CUI [1,1]
- C0262926
- UMLS CUI [1,2]
- C0011900
- UMLS CUI [2,1]
- C1948041
- UMLS CUI [2,2]
- C0011900
Description
Medical History, National Cancer Institute common terminology criteria for adverse event grade finding; History of surgical procedures, National Cancer Institute common terminology criteria for adverse event grade finding
Data type
text
Alias
- UMLS CUI [1,1]
- C0262926
- UMLS CUI [1,2]
- C3887242
- UMLS CUI [2,1]
- C1948041
- UMLS CUI [2,2]
- C3887242
Description
Medical History, Date of diagnosis; History of surgical procedures, Date of diagnosis
Data type
integer
Alias
- UMLS CUI [1,1]
- C0262926
- UMLS CUI [1,2]
- C2316983
- UMLS CUI [2,1]
- C1948041
- UMLS CUI [2,2]
- C2316983
Description
Medical History, Current, Past; History of surgical procedures, Current, Past
Data type
text
Alias
- UMLS CUI [1,1]
- C0262926
- UMLS CUI [1,2]
- C1444637
- UMLS CUI [1,3]
- C0521116
- UMLS CUI [2,1]
- C1948041
- UMLS CUI [2,2]
- C1444637
- UMLS CUI [2,3]
- C0521116
Description
Prior and Concomitant Medication
Alias
- UMLS CUI-1
- C0013227
- UMLS CUI-2
- C0205156
- UMLS CUI-4
- C2347852
Description
Concomitant Agent
Data type
boolean
Alias
- UMLS CUI [1]
- C2347852
Description
Concomitant Agent, Medication name
Data type
text
Alias
- UMLS CUI [1,1]
- C2347852
- UMLS CUI [1,2]
- C2360065
Description
Concomitant Agent, Unit of Measure, Dosage
Data type
text
Alias
- UMLS CUI [1,1]
- C2347852
- UMLS CUI [1,2]
- C1519795
- UMLS CUI [1,3]
- C0178602
Description
Concomitant Agent, Frequencies
Data type
text
Alias
- UMLS CUI [1,1]
- C2347852
- UMLS CUI [1,2]
- C0439603
Description
Concomitant Agent, Drug Administration Routes
Data type
text
Alias
- UMLS CUI [1,1]
- C2347852
- UMLS CUI [1,2]
- C0013153
Description
Concomitant Agent, Disease
Data type
text
Alias
- UMLS CUI [1,1]
- C2347852
- UMLS CUI [1,2]
- C0012634
Description
Concomitant Medication Start Date
Data type
date
Alias
- UMLS CUI [1]
- C2826734
Description
Concomitant Medication End Date
Data type
date
Alias
- UMLS CUI [1]
- C2826744
Description
Concomitant Medication Ongoing
Data type
boolean
Alias
- UMLS CUI [1]
- C2826666
Description
Inclusion Criteria
Alias
- UMLS CUI-1
- C1512693
Description
Rectal Carcinoma, Histology
Data type
boolean
Alias
- UMLS CUI [1,1]
- C0007113
- UMLS CUI [1,2]
- C0019638
Description
Informed Consent
Data type
boolean
Alias
- UMLS CUI [1]
- C0021430
Description
Therapeutic radiology procedure, Preoperative
Data type
text
Alias
- UMLS CUI [1,1]
- C1522449
- UMLS CUI [1,2]
- C0445204
Description
Primary Tumor, TNM clinical staging
Data type
boolean
Alias
- UMLS CUI [1,1]
- C0677930
- UMLS CUI [1,2]
- C3258246
Description
Age
Data type
boolean
Alias
- UMLS CUI [1]
- C0001779
Description
ECOG performance status
Data type
boolean
Alias
- UMLS CUI [1]
- C1520224
Description
Rectal Carcinoma, Date of diagnosis
Data type
boolean
Alias
- UMLS CUI [1,1]
- C0007113
- UMLS CUI [1,2]
- C2316983
Description
Operative Surgical Procedures, Previous, Complete Recovery
Data type
boolean
Alias
- UMLS CUI [1,1]
- C0543467
- UMLS CUI [1,2]
- C0205156
- UMLS CUI [1,3]
- C2826210
Description
Life Expectancy
Data type
boolean
Alias
- UMLS CUI [1]
- C0023671
Description
Laboratory Procedures
Data type
boolean
Alias
- UMLS CUI [1]
- C0022885
Description
Exclusion Criteria
Alias
- UMLS CUI-1
- C0680251
Description
Primary tumor, Excision, Total
Data type
boolean
Alias
- UMLS CUI [1,1]
- C0677930
- UMLS CUI [1,2]
- C0728940
- UMLS CUI [1,3]
- C0439810
Description
Rectal Carcinoma, Recurrent
Data type
boolean
Alias
- UMLS CUI [1,1]
- C0007113
- UMLS CUI [1,2]
- C2945760
Description
Topotecan, Previous
Data type
boolean
Alias
- UMLS CUI [1,1]
- C0146224
- UMLS CUI [1,2]
- C0205156
Description
Communicable Diseases, Active
Data type
boolean
Alias
- UMLS CUI [1,1]
- C0009450
- UMLS CUI [1,2]
- C0205177
Description
Immunologic Deficiency Syndromes
Data type
boolean
Alias
- UMLS CUI [1]
- C0021051
Description
Gastrointestinal Diseases
Data type
boolean
Alias
- UMLS CUI [1]
- C0017178
Description
Vomiting, Uncontrolled
Data type
boolean
Alias
- UMLS CUI [1,1]
- C0042963
- UMLS CUI [1,2]
- C0205318
Description
Malignant Neoplasms, Comorbidity; Malignant Neoplasms, Previous
Data type
boolean
Alias
- UMLS CUI [1,1]
- C0006826
- UMLS CUI [1,2]
- C0009488
- UMLS CUI [2,1]
- C0006826
- UMLS CUI [2,2]
- C0205156
Description
Comorbidity, Severe
Data type
boolean
Alias
- UMLS CUI [1,1]
- C0009488
- UMLS CUI [1,2]
- C0205082
Description
Childbearing potential, Contraceptive methods
Data type
boolean
Alias
- UMLS CUI [1,1]
- C3831118
- UMLS CUI [1,2]
- C0700589
Description
Pregnancy; Breast Feeding
Data type
boolean
Alias
- UMLS CUI [1,1]
- C0032961
- UMLS CUI [1,2]
- C0006147
Description
Study Subject Participation Status
Data type
boolean
Alias
- UMLS CUI [1]
- C2348568
Similar models
Screening
- StudyEvent: ODM
C1300638 (UMLS CUI [1,2])
C1519795 (UMLS CUI [1,2])
C1519795 (UMLS CUI [1,2])
C1519795 (UMLS CUI [1,2])
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C0489786 (UMLS CUI [1,3])
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C0205156 (UMLS CUI [1,3])
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C0205156 (UMLS CUI [1,3])
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C0430022 (UMLS CUI-3)
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C0430022 (UMLS CUI [1,3])
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C0430022 (UMLS CUI [1,3])
C1272696 (UMLS CUI [1,4])
C0439849 (UMLS CUI-2)
C0007113 (UMLS CUI-3)
C0439849 (UMLS CUI [1,2])
C0007113 (UMLS CUI [1,3])
C0439849 (UMLS CUI [1,2])
C0007113 (UMLS CUI [1,3])
C0439849 (UMLS CUI [1,2])
C0007113 (UMLS CUI [1,3])
C3887242 (UMLS CUI [1,4])
C0439849 (UMLS CUI [1,2])
C0007113 (UMLS CUI [1,3])
C2316983 (UMLS CUI [1,4])
C0489540 (UMLS CUI-2)
C0031809 (UMLS CUI-3)
C0489540 (UMLS CUI [2])
C0011900 (UMLS CUI [1,2])
C1948041 (UMLS CUI [2,1])
C0011900 (UMLS CUI [2,2])
C3887242 (UMLS CUI [1,2])
C1948041 (UMLS CUI [2,1])
C3887242 (UMLS CUI [2,2])
C2316983 (UMLS CUI [1,2])
C1948041 (UMLS CUI [2,1])
C2316983 (UMLS CUI [2,2])
C1444637 (UMLS CUI [1,2])
C0521116 (UMLS CUI [1,3])
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C0205156 (UMLS CUI [1,2])
C2826210 (UMLS CUI [1,3])
C0728940 (UMLS CUI [1,2])
C0439810 (UMLS CUI [1,3])
C2945760 (UMLS CUI [1,2])
C0205156 (UMLS CUI [1,2])
C0205177 (UMLS CUI [1,2])
C0205318 (UMLS CUI [1,2])
C0009488 (UMLS CUI [1,2])
C0006826 (UMLS CUI [2,1])
C0205156 (UMLS CUI [2,2])
C0205082 (UMLS CUI [1,2])
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