ID

42581

Description

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

Lien

https://clinicaltrials.gov/show/NCT01655628

Mots-clés

  1. 15/09/2021 15/09/2021 -
Détendeur de droits

Sun Yat-sen University

Téléchargé le

15 septembre 2021

DOI

Pour une demande vous connecter.

Licence

Creative Commons BY-NC 4.0

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Eligibility Stage IV Nasopharyngeal Carcinoma NCT01655628

Eligibility Stage IV Nasopharyngeal Carcinoma NCT01655628

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

Type de données

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

Type de données

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

Type de données

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

Type de données

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

Type de données

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

Type de données

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

Type de données

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

Type de données

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

Type de données

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

Type de données

boolean

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

Ecog performance status

Type de données

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

Type de données

boolean

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

Similar models

Eligibility Stage IV Nasopharyngeal Carcinoma NCT01655628

Name
Type
Description | Question | Decode (Coded Value)
Type de données
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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