ID
37677
Beschrijving
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
Trefwoorden
Versies (1)
- 16-08-19 16-08-19 -
Houder van rechten
GlaxoSmithKline
Geüploaded op
16 augustus 2019
DOI
Voor een aanvraag inloggen.
Licentie
Creative Commons BY-NC 3.0
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Oral Topotecan as Radiosensitizing Agent in Patients with Rectal Cancer; NCT00158886
Screening
- StudyEvent: ODM
Beschrijving
Demography
Alias
- UMLS CUI-1
- C0011298
Beschrijving
Vital Signs
Alias
- UMLS CUI-1
- C0518766
Beschrijving
Body Height, Unit of Measure
Datatype
text
Alias
- UMLS CUI [1,1]
- C0005890
- UMLS CUI [1,2]
- C1519795
Beschrijving
Body Height
Datatype
float
Alias
- UMLS CUI [1]
- C0005890
Beschrijving
Body Weight, Unit of Measure
Datatype
text
Alias
- UMLS CUI [1,1]
- C0005910
- UMLS CUI [1,2]
- C1519795
Beschrijving
Body Weight
Datatype
float
Alias
- UMLS CUI [1]
- C0005910
Beschrijving
Body temperature measurement site
Datatype
text
Alias
- UMLS CUI [1]
- C0489453
Beschrijving
Body Temperature, Unit of Measure
Datatype
text
Alias
- UMLS CUI [1,1]
- C0005903
- UMLS CUI [1,2]
- C1519795
Beschrijving
Body Temperature
Datatype
float
Alias
- UMLS CUI [1]
- C0005903
Beschrijving
Systolic Pressure, Sitting position
Datatype
integer
Maateenheden
- mmHg
Alias
- UMLS CUI [1,1]
- C0871470
- UMLS CUI [1,2]
- C0277814
Beschrijving
Diastolic blood pressure, Sitting position
Datatype
integer
Maateenheden
- mmHg
Alias
- UMLS CUI [1,1]
- C0428883
- UMLS CUI [1,2]
- C0277814
Beschrijving
Heart rate, Sitting position
Datatype
integer
Maateenheden
- bpm
Alias
- UMLS CUI [1,1]
- C0018810
- UMLS CUI [1,2]
- C0277814
Beschrijving
History of Rectal Carcinoma
Alias
- UMLS CUI-1
- C0007113
- UMLS CUI-2
- C0262926
Beschrijving
Rectal Carcinoma, Primary Disorders, Date of diagnosis
Datatype
date
Alias
- UMLS CUI [1,1]
- C0007113
- UMLS CUI [1,2]
- C0277554
- UMLS CUI [1,3]
- C2316983
Beschrijving
Rectal Carcinoma, TNM clinical staging, primary tumor
Datatype
text
Alias
- UMLS CUI [1,1]
- C0007113
- UMLS CUI [1,2]
- C3258246
- UMLS CUI [1,3]
- C0677930
Beschrijving
Rectal Carcinoma, TNM clinical staging, Lymph nodes
Datatype
text
Alias
- UMLS CUI [1,1]
- C0007113
- UMLS CUI [1,2]
- C3258246
- UMLS CUI [1,3]
- C0024204
Beschrijving
Rectal Carcinoma, TNM clinical staging, Neoplasm Metastasis
Datatype
text
Alias
- UMLS CUI [1,1]
- C0007113
- UMLS CUI [1,2]
- C3258246
- UMLS CUI [1,3]
- C0027627
Beschrijving
Rectal Carcinoma, Tumor Size, Height
Datatype
float
Maateenheden
- cm
Alias
- UMLS CUI [1,1]
- C0007113
- UMLS CUI [1,2]
- C0475440
- UMLS CUI [1,3]
- C0489786
Beschrijving
Rectal Carcinoma, Tumor Size, Width
Datatype
float
Maateenheden
- cm
Alias
- UMLS CUI [1,1]
- C0007113
- UMLS CUI [1,2]
- C0475440
- UMLS CUI [1,3]
- C0487742
Beschrijving
Rectal Carcinoma, Tumor Size, Diameter
Datatype
float
Maateenheden
- cm
Alias
- UMLS CUI [1,1]
- C0007113
- UMLS CUI [1,2]
- C0475440
- UMLS CUI [1,3]
- C1301886
Beschrijving
Rectal Carcinoma, Ulceration
Datatype
boolean
Alias
- UMLS CUI [1,1]
- C0007113
- UMLS CUI [1,2]
- C3887532
Beschrijving
Rectal Carcinoma, Fixation
Datatype
boolean
Alias
- UMLS CUI [1,1]
- C0007113
- UMLS CUI [1,2]
- C0185023
Beschrijving
Previous Surgical Procedures for Rectal Carcinoma
Alias
- UMLS CUI-1
- C0007113
- UMLS CUI-2
- C0543467
- UMLS CUI-3
- C0205156
Beschrijving
Rectal Carcinoma, Operative Surgical Procedures, Previous
Datatype
boolean
Alias
- UMLS CUI [1,1]
- C0007113
- UMLS CUI [1,2]
- C0543467
- UMLS CUI [1,3]
- C0205156
Beschrijving
Rectal Carcinoma, Operative Surgical Procedures, Previous
Datatype
text
Alias
- UMLS CUI [1,1]
- C0007113
- UMLS CUI [1,2]
- C0543467
- UMLS CUI [1,3]
- C0205156
Beschrijving
Rectal Carcinoma, Operative Surgical Procedures, Date in time
Datatype
text
Alias
- UMLS CUI [1,1]
- C0007113
- UMLS CUI [1,2]
- C0543467
- UMLS CUI [1,3]
- C0011008
Beschrijving
12-Lead Electrocardiogram
Alias
- UMLS CUI-1
- C0430456
Beschrijving
Diagnostic Studies for Tumor Assessment
Alias
- UMLS CUI-1
- C0007113
- UMLS CUI-2
- C0220825
- UMLS CUI-3
- C0430022
Beschrijving
Rectal Carcinoma, Evaluation, Diagnostic procedure
Datatype
text
Alias
- UMLS CUI [1,1]
- C0007113
- UMLS CUI [1,2]
- C0220825
- UMLS CUI [1,3]
- C0430022
Beschrijving
Rectal Carcinoma, Evaluation, Diagnostic procedure, Date in time
Datatype
date
Alias
- UMLS CUI [1,1]
- C0007113
- UMLS CUI [1,2]
- C0220825
- UMLS CUI [1,3]
- C0430022
- UMLS CUI [1,4]
- C0011008
Beschrijving
Rectal Carcinoma, Evaluation, Diagnostic procedure, Clinical Significance
Datatype
text
Alias
- UMLS CUI [1,1]
- C0007113
- UMLS CUI [1,2]
- C0220825
- UMLS CUI [1,3]
- C0430022
- UMLS CUI [1,4]
- C2826293
Beschrijving
Rectal Carcinoma, Evaluation, Diagnostic procedure, Not Done
Datatype
boolean
Alias
- UMLS CUI [1,1]
- C0007113
- UMLS CUI [1,2]
- C0220825
- UMLS CUI [1,3]
- C0430022
- UMLS CUI [1,4]
- C1272696
Beschrijving
Ongoing Medical Conditions Associated with Rectal Carcinoma
Alias
- UMLS CUI-1
- C0012634
- UMLS CUI-2
- C0439849
- UMLS CUI-3
- C0007113
Beschrijving
Disease, Relationships, Rectal Carcinoma
Datatype
boolean
Alias
- UMLS CUI [1,1]
- C0012634
- UMLS CUI [1,2]
- C0439849
- UMLS CUI [1,3]
- C0007113
Beschrijving
Disease, Relationships, Rectal Carcinoma
Datatype
text
Alias
- UMLS CUI [1,1]
- C0012634
- UMLS CUI [1,2]
- C0439849
- UMLS CUI [1,3]
- C0007113
Beschrijving
Disease, Relationships, Rectal Carcinoma, National Cancer Institute common terminology criteria for adverse event grade finding
Datatype
text
Alias
- UMLS CUI [1,1]
- C0012634
- UMLS CUI [1,2]
- C0439849
- UMLS CUI [1,3]
- C0007113
- UMLS CUI [1,4]
- C3887242
Beschrijving
Disease, Relationships, Rectal Carcinoma, Date of diagnosis
Datatype
integer
Alias
- UMLS CUI [1,1]
- C0012634
- UMLS CUI [1,2]
- C0439849
- UMLS CUI [1,3]
- C0007113
- UMLS CUI [1,4]
- C2316983
Beschrijving
Significant Medical/Surgical History and Physical Examination
Alias
- UMLS CUI-1
- C0262926
- UMLS CUI-2
- C0489540
- UMLS CUI-3
- C0031809
Beschrijving
Medical History; History of surgical procedures
Datatype
boolean
Alias
- UMLS CUI [1]
- C0262926
- UMLS CUI [2]
- C0489540
Beschrijving
Medical History, Diagnosis; History of surgical procedures, Diagnosis
Datatype
text
Alias
- UMLS CUI [1,1]
- C0262926
- UMLS CUI [1,2]
- C0011900
- UMLS CUI [2,1]
- C1948041
- UMLS CUI [2,2]
- C0011900
Beschrijving
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
Datatype
text
Alias
- UMLS CUI [1,1]
- C0262926
- UMLS CUI [1,2]
- C3887242
- UMLS CUI [2,1]
- C1948041
- UMLS CUI [2,2]
- C3887242
Beschrijving
Medical History, Date of diagnosis; History of surgical procedures, Date of diagnosis
Datatype
integer
Alias
- UMLS CUI [1,1]
- C0262926
- UMLS CUI [1,2]
- C2316983
- UMLS CUI [2,1]
- C1948041
- UMLS CUI [2,2]
- C2316983
Beschrijving
Medical History, Current, Past; History of surgical procedures, Current, Past
Datatype
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
Beschrijving
Prior and Concomitant Medication
Alias
- UMLS CUI-1
- C0013227
- UMLS CUI-2
- C0205156
- UMLS CUI-4
- C2347852
Beschrijving
Concomitant Agent
Datatype
boolean
Alias
- UMLS CUI [1]
- C2347852
Beschrijving
Concomitant Agent, Medication name
Datatype
text
Alias
- UMLS CUI [1,1]
- C2347852
- UMLS CUI [1,2]
- C2360065
Beschrijving
Concomitant Agent, Unit of Measure, Dosage
Datatype
text
Alias
- UMLS CUI [1,1]
- C2347852
- UMLS CUI [1,2]
- C1519795
- UMLS CUI [1,3]
- C0178602
Beschrijving
Concomitant Agent, Frequencies
Datatype
text
Alias
- UMLS CUI [1,1]
- C2347852
- UMLS CUI [1,2]
- C0439603
Beschrijving
Concomitant Agent, Drug Administration Routes
Datatype
text
Alias
- UMLS CUI [1,1]
- C2347852
- UMLS CUI [1,2]
- C0013153
Beschrijving
Concomitant Agent, Disease
Datatype
text
Alias
- UMLS CUI [1,1]
- C2347852
- UMLS CUI [1,2]
- C0012634
Beschrijving
Concomitant Medication Start Date
Datatype
date
Alias
- UMLS CUI [1]
- C2826734
Beschrijving
Concomitant Medication End Date
Datatype
date
Alias
- UMLS CUI [1]
- C2826744
Beschrijving
Concomitant Medication Ongoing
Datatype
boolean
Alias
- UMLS CUI [1]
- C2826666
Beschrijving
Inclusion Criteria
Alias
- UMLS CUI-1
- C1512693
Beschrijving
Rectal Carcinoma, Histology
Datatype
boolean
Alias
- UMLS CUI [1,1]
- C0007113
- UMLS CUI [1,2]
- C0019638
Beschrijving
Informed Consent
Datatype
boolean
Alias
- UMLS CUI [1]
- C0021430
Beschrijving
Therapeutic radiology procedure, Preoperative
Datatype
text
Alias
- UMLS CUI [1,1]
- C1522449
- UMLS CUI [1,2]
- C0445204
Beschrijving
Primary Tumor, TNM clinical staging
Datatype
boolean
Alias
- UMLS CUI [1,1]
- C0677930
- UMLS CUI [1,2]
- C3258246
Beschrijving
Age
Datatype
boolean
Alias
- UMLS CUI [1]
- C0001779
Beschrijving
ECOG performance status
Datatype
boolean
Alias
- UMLS CUI [1]
- C1520224
Beschrijving
Rectal Carcinoma, Date of diagnosis
Datatype
boolean
Alias
- UMLS CUI [1,1]
- C0007113
- UMLS CUI [1,2]
- C2316983
Beschrijving
Operative Surgical Procedures, Previous, Complete Recovery
Datatype
boolean
Alias
- UMLS CUI [1,1]
- C0543467
- UMLS CUI [1,2]
- C0205156
- UMLS CUI [1,3]
- C2826210
Beschrijving
Life Expectancy
Datatype
boolean
Alias
- UMLS CUI [1]
- C0023671
Beschrijving
Laboratory Procedures
Datatype
boolean
Alias
- UMLS CUI [1]
- C0022885
Beschrijving
Exclusion Criteria
Alias
- UMLS CUI-1
- C0680251
Beschrijving
Primary tumor, Excision, Total
Datatype
boolean
Alias
- UMLS CUI [1,1]
- C0677930
- UMLS CUI [1,2]
- C0728940
- UMLS CUI [1,3]
- C0439810
Beschrijving
Rectal Carcinoma, Recurrent
Datatype
boolean
Alias
- UMLS CUI [1,1]
- C0007113
- UMLS CUI [1,2]
- C2945760
Beschrijving
Topotecan, Previous
Datatype
boolean
Alias
- UMLS CUI [1,1]
- C0146224
- UMLS CUI [1,2]
- C0205156
Beschrijving
Communicable Diseases, Active
Datatype
boolean
Alias
- UMLS CUI [1,1]
- C0009450
- UMLS CUI [1,2]
- C0205177
Beschrijving
Immunologic Deficiency Syndromes
Datatype
boolean
Alias
- UMLS CUI [1]
- C0021051
Beschrijving
Gastrointestinal Diseases
Datatype
boolean
Alias
- UMLS CUI [1]
- C0017178
Beschrijving
Vomiting, Uncontrolled
Datatype
boolean
Alias
- UMLS CUI [1,1]
- C0042963
- UMLS CUI [1,2]
- C0205318
Beschrijving
Malignant Neoplasms, Comorbidity; Malignant Neoplasms, Previous
Datatype
boolean
Alias
- UMLS CUI [1,1]
- C0006826
- UMLS CUI [1,2]
- C0009488
- UMLS CUI [2,1]
- C0006826
- UMLS CUI [2,2]
- C0205156
Beschrijving
Comorbidity, Severe
Datatype
boolean
Alias
- UMLS CUI [1,1]
- C0009488
- UMLS CUI [1,2]
- C0205082
Beschrijving
Childbearing potential, Contraceptive methods
Datatype
boolean
Alias
- UMLS CUI [1,1]
- C3831118
- UMLS CUI [1,2]
- C0700589
Beschrijving
Pregnancy; Breast Feeding
Datatype
boolean
Alias
- UMLS CUI [1,1]
- C0032961
- UMLS CUI [1,2]
- C0006147
Beschrijving
Study Subject Participation Status
Datatype
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])
C0277814 (UMLS CUI [1,2])
C0277814 (UMLS CUI [1,2])
C0277814 (UMLS CUI [1,2])
C0262926 (UMLS CUI-2)
C0277554 (UMLS CUI [1,2])
C2316983 (UMLS CUI [1,3])
C3258246 (UMLS CUI [1,2])
C0677930 (UMLS CUI [1,3])
C3258246 (UMLS CUI [1,2])
C0024204 (UMLS CUI [1,3])
C3258246 (UMLS CUI [1,2])
C0027627 (UMLS CUI [1,3])
C0475440 (UMLS CUI [1,2])
C0489786 (UMLS CUI [1,3])
C0475440 (UMLS CUI [1,2])
C0487742 (UMLS CUI [1,3])
C0475440 (UMLS CUI [1,2])
C1301886 (UMLS CUI [1,3])
C3887532 (UMLS CUI [1,2])
C0185023 (UMLS CUI [1,2])
C0543467 (UMLS CUI-2)
C0205156 (UMLS CUI-3)
C0543467 (UMLS CUI [1,2])
C0205156 (UMLS CUI [1,3])
C0543467 (UMLS CUI [1,2])
C0205156 (UMLS CUI [1,3])
C0543467 (UMLS CUI [1,2])
C0011008 (UMLS CUI [1,3])
C0011008 (UMLS CUI [1,2])
C0220825 (UMLS CUI-2)
C0430022 (UMLS CUI-3)
C0220825 (UMLS CUI [1,2])
C0430022 (UMLS CUI [1,3])
C0220825 (UMLS CUI [1,2])
C0430022 (UMLS CUI [1,3])
C0011008 (UMLS CUI [1,4])
C0220825 (UMLS CUI [1,2])
C0430022 (UMLS CUI [1,3])
C2826293 (UMLS CUI [1,4])
C0220825 (UMLS CUI [1,2])
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])
C1948041 (UMLS CUI [2,1])
C1444637 (UMLS CUI [2,2])
C0521116 (UMLS CUI [2,3])
C0205156 (UMLS CUI-2)
C2347852 (UMLS CUI-4)
C2360065 (UMLS CUI [1,2])
C1519795 (UMLS CUI [1,2])
C0178602 (UMLS CUI [1,3])
C0439603 (UMLS CUI [1,2])
C0013153 (UMLS CUI [1,2])
C0012634 (UMLS CUI [1,2])
C0019638 (UMLS CUI [1,2])
C0445204 (UMLS CUI [1,2])
C3258246 (UMLS CUI [1,2])
C2316983 (UMLS CUI [1,2])
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])
C0700589 (UMLS CUI [1,2])
C0006147 (UMLS CUI [1,2])