ID

42581

Description

GC Regimen Chemotherapy Plus CIK Cells for Metastatic Nasopharyngeal Carcinoma; ODM derived from: https://clinicaltrials.gov/show/NCT01655628

Link

https://clinicaltrials.gov/show/NCT01655628

Keywords

Versions (1)
  1. 9/15/21 9/15/21 -
Copyright Holder

Sun Yat-sen University

Uploaded on

September 15, 2021

DOI

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License

Creative Commons BY-NC 4.0
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Eligibility Stage IV Nasopharyngeal Carcinoma NCT01655628

English

Eligibility Stage IV Nasopharyngeal Carcinoma NCT01655628

1 forms  
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
1. the primary lesions of all patients were classified as undifferentiated, non-keratinizing carcinoma at the initial stage for treatment (who, 1991 criteria) and no distant metastasis was observed based on imaging studies before radiotherapy ;
Description

Primary lesions initially classified as Undifferentiated non-keratinizing carcinoma | No distant metastasis before radiotherapy

Data type

boolean

Alias
UMLS CUI [1,1]
C1402294
UMLS CUI [1,2]
C0679228
UMLS CUI [1,3]
C1334926
UMLS CUI [1,4]
C0205698
UMLS CUI [1,5]
C4071762
UMLS CUI [2,1]
C0027627
UMLS CUI [2,2]
C0332152
UMLS CUI [2,3]
C1522449
UMLS CUI [2,4]
C0332197
2. all patients had received standard doses of radiotherapy, were regularly followed-up after radiotherapy, and had distant metastatic lesions revealed by imaging studies;
Description

Standard doses of radiotherapy | Regular follow-up | Distant metastasis revealed by imaging studies

Data type

boolean

Alias
UMLS CUI [1,1]
C1522449
UMLS CUI [1,2]
C0034524
UMLS CUI [1,3]
C1442989
UMLS CUI [2,1]
C1522577
UMLS CUI [2,2]
C0205272
UMLS CUI [3,1]
C0027627
UMLS CUI [3,2]
C0011923
3. metastases were found more than 6 months after the end of radiotherapy, with the expected survival time of more than 3 months;
Description

Metastasis found after the radiotherapy | Life expectancy

Data type

boolean

Alias
UMLS CUI [1,1]
C0027627
UMLS CUI [1,2]
C2316983
UMLS CUI [1,3]
C1522449
UMLS CUI [2]
C0023671
4. in each case, no more than 10 metastatic lesions were found in the imaging studies;
Description

Quantity of metastasis found in the imaging studies

Data type

boolean

Alias
UMLS CUI [1,1]
C0027627
UMLS CUI [1,2]
C1265611
UMLS CUI [1,3]
C0011923
5. eastern cooperative oncology group (ecog) performance status was 0 - 1;
Description

Ecog performance status

Data type

boolean

Alias
UMLS CUI [1]
C1520224
6. the bone marrow functioned normally (wbc > 4.0×109/l, hb > 120 g/l, plt > 100×109/l);
Description

Normal bone marrow function | White blood cell count | Hemoglobin measurement | Platelet count

Data type

boolean

Alias
UMLS CUI [1,1]
C0005953
UMLS CUI [1,2]
C0031843
UMLS CUI [1,3]
C0205307
UMLS CUI [2]
C0023508
UMLS CUI [3]
C0518015
UMLS CUI [4]
C0032181
7. the ecg results were normal, and the liver and kidney were functional.
Description

ECG normal | Normal liver function | Normal kidney function

Data type

boolean

Alias
UMLS CUI [1,1]
C0522054
UMLS CUI [1,2]
C0205307
UMLS CUI [2,1]
C0232741
UMLS CUI [2,2]
C0205307
UMLS CUI [3,1]
C0232804
UMLS CUI [3,2]
C0205307
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
1. patients were excluded if they had central nervous system metastases;
Description

Central nervous system metastases

Data type

boolean

Alias
UMLS CUI [1]
C0686377
2. uncontrolled infection; underlying disease that was severe or life-threatening;
Description

Uncontrolled communicable diseases | Severe disease | Life-threatening disease

Data type

boolean

Alias
UMLS CUI [1,1]
C0009450
UMLS CUI [1,2]
C0205318
UMLS CUI [2,1]
C0012634
UMLS CUI [2,2]
C0205082
UMLS CUI [3,1]
C0012634
UMLS CUI [3,2]
C2826244
3. the patients were pregnant or lactating;
Description

Pregnancy | Breast feeding

Data type

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C0006147
4. ecog perform status ≥ 2;
Description

Ecog performance status

Data type

boolean

Alias
UMLS CUI [1]
C1520224
5. the patients who are suffering from auto immune diseases or patients who need to accept glucocorticoid treatment.
Description

Autoimunne diseases | Adrenal cortex hormones

Data type

boolean

Alias
UMLS CUI [1]
C0004364
UMLS CUI [2]
C0001617
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Similar models

Eligibility Stage IV Nasopharyngeal Carcinoma NCT01655628

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
Primary lesions initially classified as Undifferentiated non-keratinizing carcinoma | No distant metastasis before radiotherapy
Item
1. the primary lesions of all patients were classified as undifferentiated, non-keratinizing carcinoma at the initial stage for treatment (who, 1991 criteria) and no distant metastasis was observed based on imaging studies before radiotherapy ;
boolean
C1402294 (UMLS CUI [1,1])
C0679228 (UMLS CUI [1,2])
C1334926 (UMLS CUI [1,3])
C0205698 (UMLS CUI [1,4])
C4071762 (UMLS CUI [1,5])
C0027627 (UMLS CUI [2,1])
C0332152 (UMLS CUI [2,2])
C1522449 (UMLS CUI [2,3])
C0332197 (UMLS CUI [2,4])
Standard doses of radiotherapy | Regular follow-up | Distant metastasis revealed by imaging studies
Item
2. all patients had received standard doses of radiotherapy, were regularly followed-up after radiotherapy, and had distant metastatic lesions revealed by imaging studies;
boolean
C1522449 (UMLS CUI [1,1])
C0034524 (UMLS CUI [1,2])
C1442989 (UMLS CUI [1,3])
C1522577 (UMLS CUI [2,1])
C0205272 (UMLS CUI [2,2])
C0027627 (UMLS CUI [3,1])
C0011923 (UMLS CUI [3,2])
Metastasis found after the radiotherapy | Life expectancy
Item
3. metastases were found more than 6 months after the end of radiotherapy, with the expected survival time of more than 3 months;
boolean
C0027627 (UMLS CUI [1,1])
C2316983 (UMLS CUI [1,2])
C1522449 (UMLS CUI [1,3])
C0023671 (UMLS CUI [2])
Quantity of metastasis found in the imaging studies
Item
4. in each case, no more than 10 metastatic lesions were found in the imaging studies;
boolean
C0027627 (UMLS CUI [1,1])
C1265611 (UMLS CUI [1,2])
C0011923 (UMLS CUI [1,3])
Ecog performance status
Item
5. eastern cooperative oncology group (ecog) performance status was 0 - 1;
boolean
C1520224 (UMLS CUI [1])
Normal bone marrow function | White blood cell count | Hemoglobin measurement | Platelet count
Item
6. the bone marrow functioned normally (wbc > 4.0×109/l, hb > 120 g/l, plt > 100×109/l);
boolean
C0005953 (UMLS CUI [1,1])
C0031843 (UMLS CUI [1,2])
C0205307 (UMLS CUI [1,3])
C0023508 (UMLS CUI [2])
C0518015 (UMLS CUI [3])
C0032181 (UMLS CUI [4])
ECG normal | Normal liver function | Normal kidney function
Item
7. the ecg results were normal, and the liver and kidney were functional.
boolean
C0522054 (UMLS CUI [1,1])
C0205307 (UMLS CUI [1,2])
C0232741 (UMLS CUI [2,1])
C0205307 (UMLS CUI [2,2])
C0232804 (UMLS CUI [3,1])
C0205307 (UMLS CUI [3,2])
Item Group
C0680251 (UMLS CUI)
Central nervous system metastases
Item
1. patients were excluded if they had central nervous system metastases;
boolean
C0686377 (UMLS CUI [1])
Uncontrolled communicable diseases | Severe disease | Life-threatening disease
Item
2. uncontrolled infection; underlying disease that was severe or life-threatening;
boolean
C0009450 (UMLS CUI [1,1])
C0205318 (UMLS CUI [1,2])
C0012634 (UMLS CUI [2,1])
C0205082 (UMLS CUI [2,2])
C0012634 (UMLS CUI [3,1])
C2826244 (UMLS CUI [3,2])
Pregnancy | Breast feeding
Item
3. the patients were pregnant or lactating;
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
Ecog performance status
Item
4. ecog perform status ≥ 2;
boolean
C1520224 (UMLS CUI [1])
Autoimunne diseases | Adrenal cortex hormones
Item
5. the patients who are suffering from auto immune diseases or patients who need to accept glucocorticoid treatment.
boolean
C0004364 (UMLS CUI [1])
C0001617 (UMLS CUI [2])
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