ID

28344

Descripción

Phase 2 Study of Temozolomide in Pre-Selected Advanced Aerodigestive Tract Cancers (Study P04273AM2)(TERMINATED); ODM derived from: https://clinicaltrials.gov/show/NCT00423150

Link

https://clinicaltrials.gov/show/NCT00423150

Palabras clave

Versiones (1)
  1. 5/1/18 5/1/18 -
Titular de derechos de autor

See clinicaltrials.gov

Subido en

5 de enero de 2018

DOI

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Licencia

Creative Commons BY 4.0
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Eligibility Colorectal Neoplasm NCT00423150

Inglés

Eligibility Colorectal Neoplasm NCT00423150

1 formularios  
Inclusion Criteria
Descripción

Inclusion Criteria

Alias
UMLS CUI
C1512693
participants must be at least 18 years of age.
Descripción

Age

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0001779
participants must have metastatic colorectal cancer (crc), recurrent or metastatic head & neck (h&n) or esophageal cancer, or locally advanced, inoperable, or metastatic non-small cell lung cancer (nsclc).
Descripción

Colorectal cancer metastatic | Recurrent Head and Neck Carcinoma | Head and neck cancer metastatic | Oesophageal carcinoma recurrent | Esophageal neoplasm metastatic | Non-Small Cell Lung Carcinoma Advanced Locally | Non-Small Cell Lung Carcinoma Inoperable | Non-small cell lung cancer metastatic

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0948380
UMLS CUI [2]
C1335703
UMLS CUI [3]
C0744619
UMLS CUI [4]
C0854761
UMLS CUI [5]
C0278562
UMLS CUI [6,1]
C0007131
UMLS CUI [6,2]
C0205179
UMLS CUI [6,3]
C1517927
UMLS CUI [7,1]
C0007131
UMLS CUI [7,2]
C0205187
UMLS CUI [8]
C0278987
participants must have a tumor sample or a blood sample tested positive for the presence of the biomarker.
Descripción

Tumor tissue sample Test Positive Biomarker | Blood specimen Test Positive Biomarker

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0475358
UMLS CUI [1,2]
C0022885
UMLS CUI [1,3]
C1514241
UMLS CUI [1,4]
C0005516
UMLS CUI [2,1]
C0178913
UMLS CUI [2,2]
C0022885
UMLS CUI [2,3]
C1514241
UMLS CUI [2,4]
C0005516
participants may have up to 3 prior regimens for crc, up to 3 prior regimens for nsclc, up to 2 prior regimens for h&n and esophageal cancer.
Descripción

Prior Therapy Quantity Colorectal Carcinoma | Prior Therapy Quantity Non-Small Cell Lung Carcinoma | Prior Therapy Quantity Cancer of Head and Neck | Prior Therapy Quantity Esophageal carcinoma

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C1514463
UMLS CUI [1,2]
C1265611
UMLS CUI [1,3]
C0009402
UMLS CUI [2,1]
C1514463
UMLS CUI [2,2]
C1265611
UMLS CUI [2,3]
C0007131
UMLS CUI [3,1]
C1514463
UMLS CUI [3,2]
C1265611
UMLS CUI [3,3]
C0278996
UMLS CUI [4,1]
C1514463
UMLS CUI [4,2]
C1265611
UMLS CUI [4,3]
C0152018
participants must have at least one measurable lesion.
Descripción

Measurable lesion Quantity

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C1513041
UMLS CUI [1,2]
C1265611
participants must have an eastern cooperative oncology group (ecog) performance status of 0, 1, or 2.
Descripción

ECOG performance status

Tipo de datos

boolean

Alias
UMLS CUI [1]
C1520224
participants must have adequate hematologic, renal, and liver functions.
Descripción

Hematologic function | Renal function | Liver function

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0221130
UMLS CUI [2]
C0232804
UMLS CUI [3]
C0232741
participants must be able to take the study medication capsules orally, or through a feeding tube without the capsules being opened.
Descripción

Able to swallow Oral Capsule | Intake Capsule Feeding tube

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C2712086
UMLS CUI [1,2]
C0991533
UMLS CUI [2,1]
C1512806
UMLS CUI [2,2]
C0006935
UMLS CUI [2,3]
C2945625
participants of childbearing potential must agree to use a medically accepted method of contraception.
Descripción

Childbearing Potential Contraceptive methods

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C3831118
UMLS CUI [1,2]
C0700589
Exclusion Criteria
Descripción

Exclusion Criteria

Alias
UMLS CUI
C0680251
participants who have received treatment for a second malignancy within 1 year before screening, and are considered to be at risk of relapse within 1 year after screening.
Descripción

Therapeutic procedure Second Cancer | At risk Recurrent disease

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0087111
UMLS CUI [1,2]
C0751623
UMLS CUI [2,1]
C1444641
UMLS CUI [2,2]
C0277556
participants with unstable or progressing central nervous system (cns) metastasis. participants with known cns metastasis may be included if a) the subject is asymptomatic, b) there is no requirement for steroids or antiseizure medications, or the required doses are stable, and c) there is no associated midline shift or (in the opinion of the investigator) significant edema.
Descripción

CNS metastases Unstable | CNS metastases Progressing | Exception Study Subject Asymptomatic | Exception Steroids Redundant | Exception Anticonvulsants Redundant | Exception Pharmaceutical Preparations Dosage Stable | Exception Midline Shift Absent | Exception Edema Absent

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0686377
UMLS CUI [1,2]
C0443343
UMLS CUI [2,1]
C0686377
UMLS CUI [2,2]
C0205329
UMLS CUI [3,1]
C1705847
UMLS CUI [3,2]
C0681850
UMLS CUI [3,3]
C0231221
UMLS CUI [4,1]
C1705847
UMLS CUI [4,2]
C0038317
UMLS CUI [4,3]
C1313915
UMLS CUI [5,1]
C1705847
UMLS CUI [5,2]
C0003286
UMLS CUI [5,3]
C1313915
UMLS CUI [6,1]
C1705847
UMLS CUI [6,2]
C0013227
UMLS CUI [6,3]
C0178602
UMLS CUI [6,4]
C0205360
UMLS CUI [7,1]
C1705847
UMLS CUI [7,2]
C4086580
UMLS CUI [7,3]
C0332197
UMLS CUI [8,1]
C1705847
UMLS CUI [8,2]
C0013604
UMLS CUI [8,3]
C0332197
participants who received prior temozolomide or dacarbazine treatment
Descripción

temozolomide | Dacarbazine

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0076080
UMLS CUI [2]
C0010927
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Similar models

Eligibility Colorectal Neoplasm NCT00423150

1 formularios
Name
Tipo
Description | Question | Decode (Coded Value)
Tipo de datos
Alias
Item Group
C1512693 (UMLS CUI)
Age
Item
participants must be at least 18 years of age.
boolean
C0001779 (UMLS CUI [1])
Colorectal cancer metastatic | Recurrent Head and Neck Carcinoma | Head and neck cancer metastatic | Oesophageal carcinoma recurrent | Esophageal neoplasm metastatic | Non-Small Cell Lung Carcinoma Advanced Locally | Non-Small Cell Lung Carcinoma Inoperable | Non-small cell lung cancer metastatic
Item
participants must have metastatic colorectal cancer (crc), recurrent or metastatic head & neck (h&n) or esophageal cancer, or locally advanced, inoperable, or metastatic non-small cell lung cancer (nsclc).
boolean
C0948380 (UMLS CUI [1])
C1335703 (UMLS CUI [2])
C0744619 (UMLS CUI [3])
C0854761 (UMLS CUI [4])
C0278562 (UMLS CUI [5])
C0007131 (UMLS CUI [6,1])
C0205179 (UMLS CUI [6,2])
C1517927 (UMLS CUI [6,3])
C0007131 (UMLS CUI [7,1])
C0205187 (UMLS CUI [7,2])
C0278987 (UMLS CUI [8])
Tumor tissue sample Test Positive Biomarker | Blood specimen Test Positive Biomarker
Item
participants must have a tumor sample or a blood sample tested positive for the presence of the biomarker.
boolean
C0475358 (UMLS CUI [1,1])
C0022885 (UMLS CUI [1,2])
C1514241 (UMLS CUI [1,3])
C0005516 (UMLS CUI [1,4])
C0178913 (UMLS CUI [2,1])
C0022885 (UMLS CUI [2,2])
C1514241 (UMLS CUI [2,3])
C0005516 (UMLS CUI [2,4])
Prior Therapy Quantity Colorectal Carcinoma | Prior Therapy Quantity Non-Small Cell Lung Carcinoma | Prior Therapy Quantity Cancer of Head and Neck | Prior Therapy Quantity Esophageal carcinoma
Item
participants may have up to 3 prior regimens for crc, up to 3 prior regimens for nsclc, up to 2 prior regimens for h&n and esophageal cancer.
boolean
C1514463 (UMLS CUI [1,1])
C1265611 (UMLS CUI [1,2])
C0009402 (UMLS CUI [1,3])
C1514463 (UMLS CUI [2,1])
C1265611 (UMLS CUI [2,2])
C0007131 (UMLS CUI [2,3])
C1514463 (UMLS CUI [3,1])
C1265611 (UMLS CUI [3,2])
C0278996 (UMLS CUI [3,3])
C1514463 (UMLS CUI [4,1])
C1265611 (UMLS CUI [4,2])
C0152018 (UMLS CUI [4,3])
Measurable lesion Quantity
Item
participants must have at least one measurable lesion.
boolean
C1513041 (UMLS CUI [1,1])
C1265611 (UMLS CUI [1,2])
ECOG performance status
Item
participants must have an eastern cooperative oncology group (ecog) performance status of 0, 1, or 2.
boolean
C1520224 (UMLS CUI [1])
Hematologic function | Renal function | Liver function
Item
participants must have adequate hematologic, renal, and liver functions.
boolean
C0221130 (UMLS CUI [1])
C0232804 (UMLS CUI [2])
C0232741 (UMLS CUI [3])
Able to swallow Oral Capsule | Intake Capsule Feeding tube
Item
participants must be able to take the study medication capsules orally, or through a feeding tube without the capsules being opened.
boolean
C2712086 (UMLS CUI [1,1])
C0991533 (UMLS CUI [1,2])
C1512806 (UMLS CUI [2,1])
C0006935 (UMLS CUI [2,2])
C2945625 (UMLS CUI [2,3])
Childbearing Potential Contraceptive methods
Item
participants of childbearing potential must agree to use a medically accepted method of contraception.
boolean
C3831118 (UMLS CUI [1,1])
C0700589 (UMLS CUI [1,2])
Item Group
C0680251 (UMLS CUI)
Therapeutic procedure Second Cancer | At risk Recurrent disease
Item
participants who have received treatment for a second malignancy within 1 year before screening, and are considered to be at risk of relapse within 1 year after screening.
boolean
C0087111 (UMLS CUI [1,1])
C0751623 (UMLS CUI [1,2])
C1444641 (UMLS CUI [2,1])
C0277556 (UMLS CUI [2,2])
CNS metastases Unstable | CNS metastases Progressing | Exception Study Subject Asymptomatic | Exception Steroids Redundant | Exception Anticonvulsants Redundant | Exception Pharmaceutical Preparations Dosage Stable | Exception Midline Shift Absent | Exception Edema Absent
Item
participants with unstable or progressing central nervous system (cns) metastasis. participants with known cns metastasis may be included if a) the subject is asymptomatic, b) there is no requirement for steroids or antiseizure medications, or the required doses are stable, and c) there is no associated midline shift or (in the opinion of the investigator) significant edema.
boolean
C0686377 (UMLS CUI [1,1])
C0443343 (UMLS CUI [1,2])
C0686377 (UMLS CUI [2,1])
C0205329 (UMLS CUI [2,2])
C1705847 (UMLS CUI [3,1])
C0681850 (UMLS CUI [3,2])
C0231221 (UMLS CUI [3,3])
C1705847 (UMLS CUI [4,1])
C0038317 (UMLS CUI [4,2])
C1313915 (UMLS CUI [4,3])
C1705847 (UMLS CUI [5,1])
C0003286 (UMLS CUI [5,2])
C1313915 (UMLS CUI [5,3])
C1705847 (UMLS CUI [6,1])
C0013227 (UMLS CUI [6,2])
C0178602 (UMLS CUI [6,3])
C0205360 (UMLS CUI [6,4])
C1705847 (UMLS CUI [7,1])
C4086580 (UMLS CUI [7,2])
C0332197 (UMLS CUI [7,3])
C1705847 (UMLS CUI [8,1])
C0013604 (UMLS CUI [8,2])
C0332197 (UMLS CUI [8,3])
temozolomide | Dacarbazine
Item
participants who received prior temozolomide or dacarbazine treatment
boolean
C0076080 (UMLS CUI [1])
C0010927 (UMLS CUI [2])
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