ID

23432

Description

Responsible Party: Torsten Liersch, Prof. Dr. med., University Medical Center Goettingen ClinicalTrials.gov Identifier: NCT03034473 History of Changes Other Study ID Numbers: TransValid-KFO179/GRCSG-A DRKS00003659 ( Registry Identifier: Deutsches Register Klinischer Studien ) UTN U1111-1131-9971 ( Registry Identifier: WHO Registry Network ) Study First Received: January 13, 2017 Last Updated: January 24, 2017 Translational Validation Study to Examine KFO179-1 Biomarker Scores for the Prediction and Prognosis of Advanced Primary Resectable Rectal Cancer Stages UICC-II-IV, With a 5-Fluorouracil-based Standard Radiochemotherapy Followed by Total Mesorectal Excision. (TransValid-A) ODM derived from: https://clinicaltrials.gov/ct2/show/NCT03034473

Link

https://clinicaltrials.gov/ct2/show/NCT03034473

Keywords

Versions (1)
  1. 7/4/17 7/4/17 -
Uploaded on

July 4, 2017

DOI

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License

Creative Commons BY 4.0
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Eligibility Rectal Cancer DRKS00003659 NCT03034473 DRKS00003659

English

Eligibility Rectal Cancer NCT03034473 DRKS00003659

1 forms  
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI-1
C1512693
Aged 18 to 85 years, inclusive
Description

Age

Data type

boolean

Alias
UMLS CUI [1]
C0001779
Histologically confirmed advanced primary rectal cancer localized up to 12 cm above the anocutaneous line (determined with a rigid rectoscope), classified as T3/T4 or N+ carcinomas or with evidence for synchronous, but resectable distant metastases (liver or lung metastases)
Description

Colorectal Cancer

Data type

boolean

Alias
UMLS CUI [1]
C0009402
No specific tumor treatment except colostomy due to tumor stenosis with ileus
Description

Cancer Treatment

Data type

boolean

Alias
UMLS CUI [1]
C0920425
World Health Organization (WHO)/Eastern Cooperative Oncology Group (ECOG) status ≤2
Description

ECOG Performance Status

Data type

boolean

Alias
UMLS CUI [1]
C1520224
Adequate bone marrow function (WBC >3.0x10^9/L, neutrophils >1.5x10^9/L, thrombocytes >100x10^9/L, hemoglobin ≥10 g/dl)
Description

Bone Marrow Function

Data type

boolean

Alias
UMLS CUI [1,1]
C0005953
UMLS CUI [1,2]
C0031843
Adequate liver function (bilirubin ≤2.0 mg/dl, SGOT, SGPT, AP, gamma-GT < three point five fold of upper level of normal range
Description

Liver Function

Data type

boolean

Alias
UMLS CUI [1]
C0232741
Serum creatinine < 1.5 mg/dl
Description

Serum Creatinine

Data type

boolean

Alias
UMLS CUI [1]
C0201976
Written and signed informed consent indicating the understanding of the investigational nature and the study protocol.
Description

Informed Consent

Data type

boolean

Alias
UMLS CUI [1]
C0021430
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI-1
C0680251
Control Group
Description

Control Group

Data type

boolean

Alias
UMLS CUI [1]
C0009932
Pregnant or lactating women
Description

Gynaecological Status

Data type

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C0006147
Men and women unwilling or unable to use highly effective methods of contraception (per institutional standard) during treatment and for 6 months (male or female) after the end of treatment
Description

Contraceptive Methods

Data type

boolean

Alias
UMLS CUI [1]
C0700589
Prolonged drug, medication or alcohol abuse
Description

Substance Use Disorder

Data type

boolean

Alias
UMLS CUI [1]
C0038586
Previous chemotherapy (up to 2 years before diagnosis of rectal cancer)
Description

Prior Chemotherapy

Data type

boolean

Alias
UMLS CUI [1]
C1514457
Previous radiotherapy to the pelvic area
Description

Prior Radiotherapy

Data type

boolean

Alias
UMLS CUI [1]
C0279134
Simultaneous therapy with other anti-cancer drugs
Description

Concurrent therapy

Data type

boolean

Alias
UMLS CUI [1]
C0009429
Participation in a clinical trial in the period 30 days prior to inclusion
Description

Study Participation Status

Data type

boolean

Alias
UMLS CUI [1]
C2348568
Patients (man and woman) who are not able or willing to accept treatment and follow-up care according to trial protocol
Description

Study Protocol

Data type

boolean

Alias
UMLS CUI [1]
C2348563
Patients (man and woman) with uncontrolled, serious physical or mental diseases, e.g.: instable cardiac disease in spite of medical treatment, myocardial infarction during the last 3 months prior to start of trial participation: neurological or psychiatric dysfunction including dementia or seizure disorder
Description

Neurological or Mental Disease

Data type

boolean

Alias
UMLS CUI [1]
C0027765
UMLS CUI [2]
C0004936
Patients (man and woman) with uncontrolled, serious physical or mental diseases, e.g.: instable cardiac disease in spite of medical treatment, myocardial infarction during the last 3 months prior to start of trial participation: Disseminated infection or sepsis
Description

Infection

Data type

boolean

Alias
UMLS CUI [1]
C0009450
Patients (man and woman) with uncontrolled, serious physical or mental diseases, e.g.: instable cardiac disease in spite of medical treatment, myocardial infarction during the last 3 months prior to start of trial participation: Disseminated intravascular coagulopathy
Description

Disseminated intravascular coagulopathy

Data type

boolean

Alias
UMLS CUI [1]
C4062443
Patients (man and woman) with uncontrolled, serious physical or mental diseases, e.g.: instable cardiac disease in spite of medical treatment, myocardial infarction during the last 3 months prior to start of trial participation: Symptomatic neuropathy (NCI CTC ≥2)
Description

Neuropathy

Data type

boolean

Alias
UMLS CUI [1]
C0442874
Patients with secondary malignancies except basal cell carcinoma of the skin or carcinoma in situ of the cervix, which have been successfully treated. (The inclusion of patients with other tumors that were successfully treated and no recurrence within the last 3-5 years should be discussed before registration in the trial)
Description

Secondary malignancy

Data type

boolean

Alias
UMLS CUI [1]
C3266877
Chronic diarrhea (>grade 1 according NCI CTCAE)
Description

Chronic diarrhea

Data type

boolean

Alias
UMLS CUI [1]
C0401151
Allergic reaction to platin-derivates or study medication
Description

Hypersensitivity to Platin-Derivates or Study Medication

Data type

boolean

Alias
UMLS CUI [1,1]
C0020517
UMLS CUI [1,2]
C0032207
UMLS CUI [2,1]
C0020517
UMLS CUI [2,2]
C0304229
Simultaneous treatment with sorivudine and analogous
Description

Sorivudine

Data type

boolean

Alias
UMLS CUI [1]
C0207628
Known Dihydropyrimidine dehydrogenase deficiency
Description

Dihydropyrimidine dehydrogenase deficiency

Data type

boolean

Alias
UMLS CUI [1]
C1959620
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Similar models

Eligibility Rectal Cancer NCT03034473 DRKS00003659

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
Inclusion Criteria
C1512693 (UMLS CUI-1)
Age
Item
Aged 18 to 85 years, inclusive
boolean
C0001779 (UMLS CUI [1])
Colorectal Cancer
Item
Histologically confirmed advanced primary rectal cancer localized up to 12 cm above the anocutaneous line (determined with a rigid rectoscope), classified as T3/T4 or N+ carcinomas or with evidence for synchronous, but resectable distant metastases (liver or lung metastases)
boolean
C0009402 (UMLS CUI [1])
Cancer Treatment
Item
No specific tumor treatment except colostomy due to tumor stenosis with ileus
boolean
C0920425 (UMLS CUI [1])
ECOG Performance Status
Item
World Health Organization (WHO)/Eastern Cooperative Oncology Group (ECOG) status ≤2
boolean
C1520224 (UMLS CUI [1])
Bone Marrow Function
Item
Adequate bone marrow function (WBC >3.0x10^9/L, neutrophils >1.5x10^9/L, thrombocytes >100x10^9/L, hemoglobin ≥10 g/dl)
boolean
C0005953 (UMLS CUI [1,1])
C0031843 (UMLS CUI [1,2])
Liver Function
Item
Adequate liver function (bilirubin ≤2.0 mg/dl, SGOT, SGPT, AP, gamma-GT < three point five fold of upper level of normal range
boolean
C0232741 (UMLS CUI [1])
Serum Creatinine
Item
Serum creatinine < 1.5 mg/dl
boolean
C0201976 (UMLS CUI [1])
Informed Consent
Item
Written and signed informed consent indicating the understanding of the investigational nature and the study protocol.
boolean
C0021430 (UMLS CUI [1])
Item Group
Exclusion Criteria
C0680251 (UMLS CUI-1)
Control Group
Item
boolean
C0009932 (UMLS CUI [1])
Gynaecological Status
Item
Pregnant or lactating women
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
Contraceptive Methods
Item
Men and women unwilling or unable to use highly effective methods of contraception (per institutional standard) during treatment and for 6 months (male or female) after the end of treatment
boolean
C0700589 (UMLS CUI [1])
Substance Use Disorder
Item
Prolonged drug, medication or alcohol abuse
boolean
C0038586 (UMLS CUI [1])
Prior Chemotherapy
Item
Previous chemotherapy (up to 2 years before diagnosis of rectal cancer)
boolean
C1514457 (UMLS CUI [1])
Prior Radiotherapy
Item
Previous radiotherapy to the pelvic area
boolean
C0279134 (UMLS CUI [1])
Concurrent therapy
Item
Simultaneous therapy with other anti-cancer drugs
boolean
C0009429 (UMLS CUI [1])
Study Participation Status
Item
Participation in a clinical trial in the period 30 days prior to inclusion
boolean
C2348568 (UMLS CUI [1])
Study Protocol
Item
Patients (man and woman) who are not able or willing to accept treatment and follow-up care according to trial protocol
boolean
C2348563 (UMLS CUI [1])
Neurological or Mental Disease
Item
Patients (man and woman) with uncontrolled, serious physical or mental diseases, e.g.: instable cardiac disease in spite of medical treatment, myocardial infarction during the last 3 months prior to start of trial participation: neurological or psychiatric dysfunction including dementia or seizure disorder
boolean
C0027765 (UMLS CUI [1])
C0004936 (UMLS CUI [2])
Infection
Item
Patients (man and woman) with uncontrolled, serious physical or mental diseases, e.g.: instable cardiac disease in spite of medical treatment, myocardial infarction during the last 3 months prior to start of trial participation: Disseminated infection or sepsis
boolean
C0009450 (UMLS CUI [1])
Disseminated intravascular coagulopathy
Item
Patients (man and woman) with uncontrolled, serious physical or mental diseases, e.g.: instable cardiac disease in spite of medical treatment, myocardial infarction during the last 3 months prior to start of trial participation: Disseminated intravascular coagulopathy
boolean
C4062443 (UMLS CUI [1])
Neuropathy
Item
Patients (man and woman) with uncontrolled, serious physical or mental diseases, e.g.: instable cardiac disease in spite of medical treatment, myocardial infarction during the last 3 months prior to start of trial participation: Symptomatic neuropathy (NCI CTC ≥2)
boolean
C0442874 (UMLS CUI [1])
Secondary malignancy
Item
Patients with secondary malignancies except basal cell carcinoma of the skin or carcinoma in situ of the cervix, which have been successfully treated. (The inclusion of patients with other tumors that were successfully treated and no recurrence within the last 3-5 years should be discussed before registration in the trial)
boolean
C3266877 (UMLS CUI [1])
Chronic diarrhea
Item
Chronic diarrhea (>grade 1 according NCI CTCAE)
boolean
C0401151 (UMLS CUI [1])
Hypersensitivity to Platin-Derivates or Study Medication
Item
Allergic reaction to platin-derivates or study medication
boolean
C0020517 (UMLS CUI [1,1])
C0032207 (UMLS CUI [1,2])
C0020517 (UMLS CUI [2,1])
C0304229 (UMLS CUI [2,2])
Sorivudine
Item
Simultaneous treatment with sorivudine and analogous
boolean
C0207628 (UMLS CUI [1])
Dihydropyrimidine dehydrogenase deficiency
Item
Known Dihydropyrimidine dehydrogenase deficiency
boolean
C1959620 (UMLS CUI [1])
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