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ID

37283

Descrizione

Reduced-Volume Hypofractionated, PET-directed Intensity Modulated Radiotherapy Concurrent With Weekly Cisplatin Chemotherapy for Squamous Cell Carcinoma of the Head and Neck; ODM derived from: https://clinicaltrials.gov/show/NCT02201355

collegamento

https://clinicaltrials.gov/show/NCT02201355

Keywords

versioni (1)
  1. 13/07/19 13/07/19 -
Titolare del copyright

See clinicaltrials.gov

Caricato su

13 luglio 2019

DOI

Per favore, per richiedere un accesso.

Licenza

Creative Commons BY 4.0
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    Eligibility T1/2N0-2 Squamous Cell Carcinoma of the Head and Neck NCT02201355

    Inglese

    Eligibility T1/2N0-2 Squamous Cell Carcinoma of the Head and Neck NCT02201355

    1 moduli  
    Inclusion Criteria
    Descrizione

    Inclusion Criteria

    Alias
    UMLS CUI
    C1512693
    1. t1/2n0-2m0 scc of the oropharynx, hypopharynx or larynx
    Descrizione

    Squamous cell carcinoma of oropharynx TNM clinical staging | Squamous cell carcinoma of the hypopharynx TNM clinical staging | Laryngeal Squamous Cell Carcinoma TNM clinical staging

    Tipo di dati

    boolean

    Alias
    UMLS CUI [1,1]
    C0280313
    UMLS CUI [1,2]
    C3258246
    UMLS CUI [2,1]
    C0280321
    UMLS CUI [2,2]
    C3258246
    UMLS CUI [3,1]
    C0280324
    UMLS CUI [3,2]
    C3258246
    2. age ≥ 18 years.
    Descrizione

    Age

    Tipo di dati

    boolean

    Alias
    UMLS CUI [1]
    C0001779
    3. performance status ecog 0-1
    Descrizione

    ECOG performance status

    Tipo di dati

    boolean

    Alias
    UMLS CUI [1]
    C1520224
    4. adequate organ and marrow function as determined by medical oncology evaluation.
    Descrizione

    Organ function | Bone Marrow function

    Tipo di dati

    boolean

    Alias
    UMLS CUI [1]
    C0678852
    UMLS CUI [2,1]
    C0005953
    UMLS CUI [2,2]
    C0031843
    5. women of child-bearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry, for the duration of study participation, and for 90 days following completion of therapy. should a woman become pregnant or suspect she is pregnant while participating in this study, she should inform her treating physician immediately.
    Descrizione

    Childbearing Potential Contraceptive methods | Gender Contraceptive methods | Hormonal contraception | Contraception, Barrier | Sexual Abstinence

    Tipo di dati

    boolean

    Alias
    UMLS CUI [1,1]
    C3831118
    UMLS CUI [1,2]
    C0700589
    UMLS CUI [2,1]
    C0079399
    UMLS CUI [2,2]
    C0700589
    UMLS CUI [3]
    C2985296
    UMLS CUI [4]
    C0004764
    UMLS CUI [5]
    C0036899
    6. a female of child-bearing potential is any woman (regardless of sexual orientation, having undergone a tubal ligation, or remaining celibate by choice) who meets the following criteria:
    Descrizione

    Childbearing Potential Criteria Fulfill | Independent of Sexual Orientation | Tubal Ligation | Sexual Abstinence

    Tipo di dati

    boolean

    Alias
    UMLS CUI [1,1]
    C3831118
    UMLS CUI [1,2]
    C0243161
    UMLS CUI [1,3]
    C1550543
    UMLS CUI [2,1]
    C0332291
    UMLS CUI [2,2]
    C0205949
    UMLS CUI [3]
    C0520483
    UMLS CUI [4]
    C0036899
    has not undergone a hysterectomy or bilateral oophorectomy; or
    Descrizione

    Hysterectomy Absent | Bilateral oophorectomy Absent

    Tipo di dati

    boolean

    Alias
    UMLS CUI [1,1]
    C0020699
    UMLS CUI [1,2]
    C0332197
    UMLS CUI [2,1]
    C0278321
    UMLS CUI [2,2]
    C0332197
    has not been naturally postmenopausal for at least 12 consecutive months (i.e., has had menses at any time in the preceding 12 consecutive months).
    Descrizione

    Postmenopausal state Absent

    Tipo di dati

    boolean

    Alias
    UMLS CUI [1,1]
    C0232970
    UMLS CUI [1,2]
    C0332197
    7 ability to understand and the willingness to sign a written informed consent.
    Descrizione

    Informed Consent

    Tipo di dati

    boolean

    Alias
    UMLS CUI [1]
    C0021430
    8. creatinine clearance (cc) ≥ 50 ml/min within 4 weeks prior to registration determined by 24-hour collection or estimated by cockcroft-gault formula: ccr male = [(140 - age) x (wt in kg)]/[(serum cr mg/dl) x (72)] (ccr female = 0.85 x (crcl male)).
    Descrizione

    Creatinine clearance measurement | 24 hour renal creatinine clearance | Estimation of creatinine clearance by Cockcroft-Gault formula

    Tipo di dati

    boolean

    Alias
    UMLS CUI [1]
    C0373595
    UMLS CUI [2]
    C4032392
    UMLS CUI [3]
    C2711451
    9. history/physical examination within 4 weeks prior to registration, including assessment of weight and weight loss in past 6 months.
    Descrizione

    Medical History | Physical Examination | Assessment Body Weight | Assessment Weight loss

    Tipo di dati

    boolean

    Alias
    UMLS CUI [1]
    C0262926
    UMLS CUI [2]
    C0031809
    UMLS CUI [3,1]
    C1516048
    UMLS CUI [3,2]
    C0005910
    UMLS CUI [4,1]
    C1516048
    UMLS CUI [4,2]
    C1262477
    10. medical oncology examination to evaluate medical contraindications prior to start chemotherapy 11 dental evaluation with management prior to start of radiation 12 nutrition evaluation with consideration of percutaneous endoscopic gastrostomy (peg) tube placement 13 no distant metastasis by pet/ct
    Descrizione

    Medical oncology Examination | Evaluation Medical contraindication | DENTAL EVALUATION | Nutrition Evaluation | Consideration Percutaneous placement of gastrostomy tube | Distant metastasis Absent PET/CT scan

    Tipo di dati

    boolean

    Alias
    UMLS CUI [1,1]
    C0025098
    UMLS CUI [1,2]
    C0582103
    UMLS CUI [2,1]
    C1261322
    UMLS CUI [2,2]
    C1301624
    UMLS CUI [3]
    C0011356
    UMLS CUI [4]
    C3825905
    UMLS CUI [5,1]
    C0518609
    UMLS CUI [5,2]
    C0192460
    UMLS CUI [6,1]
    C1269798
    UMLS CUI [6,2]
    C0332197
    UMLS CUI [6,3]
    C1699633
    Exclusion Criteria
    Descrizione

    Exclusion Criteria

    Alias
    UMLS CUI
    C0680251
    1. t3/4 or n3
    Descrizione

    Disease TNM clinical staging

    Tipo di dati

    boolean

    Alias
    UMLS CUI [1,1]
    C0012634
    UMLS CUI [1,2]
    C3258246
    2. t1n0 disease
    Descrizione

    Disease TNM clinical staging

    Tipo di dati

    boolean

    Alias
    UMLS CUI [1,1]
    C0012634
    UMLS CUI [1,2]
    C3258246
    3. metastatic disease
    Descrizione

    Neoplasm Metastasis

    Tipo di dati

    boolean

    Alias
    UMLS CUI [1]
    C0027627
    4. prior invasive malignancy (except non-melanomatous skin cancer) unless disease free for a minimum of 3 years
    Descrizione

    Invasive cancer | Exception Skin carcinoma | Exception Disease Free Duration

    Tipo di dati

    boolean

    Alias
    UMLS CUI [1]
    C0677898
    UMLS CUI [2,1]
    C1705847
    UMLS CUI [2,2]
    C0699893
    UMLS CUI [3,1]
    C1705847
    UMLS CUI [3,2]
    C0012634
    UMLS CUI [3,3]
    C0332296
    UMLS CUI [3,4]
    C0449238
    5. prior radiotherapy to the region of the study cancer that would result in overlap of radiation therapy fields
    Descrizione

    Prior radiation therapy Region Clinical Trial Malignant Neoplasm | With result Overlap Radiation Field

    Tipo di dati

    boolean

    Alias
    UMLS CUI [1,1]
    C0279134
    UMLS CUI [1,2]
    C0205147
    UMLS CUI [1,3]
    C0008976
    UMLS CUI [1,4]
    C0006826
    UMLS CUI [2,1]
    C0332294
    UMLS CUI [2,2]
    C1948020
    UMLS CUI [2,3]
    C1882536
    6. primary site of tumor of oral cavity, nasopharynx, sinuses, or salivary glands
    Descrizione

    Primary tumor site Oral cavity | Primary tumor site Nasopharynx | Primary tumor site Sinuses | Primary tumor site Salivary Glands

    Tipo di dati

    boolean

    Alias
    UMLS CUI [1,1]
    C0475447
    UMLS CUI [1,2]
    C0226896
    UMLS CUI [2,1]
    C0475447
    UMLS CUI [2,2]
    C0027442
    UMLS CUI [3,1]
    C0475447
    UMLS CUI [3,2]
    C0030471
    UMLS CUI [4,1]
    C0475447
    UMLS CUI [4,2]
    C0036098
    7. neck adenopathy that involves the overlying skin.
    Descrizione

    Neck Adenopathy Involving Skin

    Tipo di dati

    boolean

    Alias
    UMLS CUI [1,1]
    C0027530
    UMLS CUI [1,2]
    C0497156
    UMLS CUI [1,3]
    C1314939
    UMLS CUI [1,4]
    C1123023
    8. initial surgical treatment including tonsillectomy or neck dissection, but excluding diagnostic biopsy of the primary site or nodal sampling of neck disease
    Descrizione

    Operative Surgical Procedure Initial | Tonsillectomy | Neck Dissection | Exception Biopsy Primary tumor site | Exception Sampling of lymph node Disorder of neck

    Tipo di dati

    boolean

    Alias
    UMLS CUI [1,1]
    C0543467
    UMLS CUI [1,2]
    C0205265
    UMLS CUI [2]
    C0040423
    UMLS CUI [3]
    C0398395
    UMLS CUI [4,1]
    C1705847
    UMLS CUI [4,2]
    C0005558
    UMLS CUI [4,3]
    C0475447
    UMLS CUI [5,1]
    C1705847
    UMLS CUI [5,2]
    C0398417
    UMLS CUI [5,3]
    C0558385
    9. pre-existing grade > 2 peripheral sensory neuropathy
    Descrizione

    Sensory neuropathy Pre-existing CTCAE Grades

    Tipo di dati

    boolean

    Alias
    UMLS CUI [1,1]
    C0151313
    UMLS CUI [1,2]
    C2347662
    UMLS CUI [1,3]
    C1516728
    10. subjects may not be receiving any other investigational agents.
    Descrizione

    Investigational New Drugs

    Tipo di dati

    boolean

    Alias
    UMLS CUI [1]
    C0013230
    11. uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements.
    Descrizione

    Comorbidity Uncontrolled | Communicable Disease | Symptomatic congestive heart failure | Angina, Unstable | Cardiac Arrhythmia | Mental disorders Limiting Protocol Compliance | Social situation Limiting Protocol Compliance

    Tipo di dati

    boolean

    Alias
    UMLS CUI [1,1]
    C0009488
    UMLS CUI [1,2]
    C0205318
    UMLS CUI [2]
    C0009450
    UMLS CUI [3]
    C0742758
    UMLS CUI [4]
    C0002965
    UMLS CUI [5]
    C0003811
    UMLS CUI [6,1]
    C0004936
    UMLS CUI [6,2]
    C0439801
    UMLS CUI [6,3]
    C0525058
    UMLS CUI [7,1]
    C0748872
    UMLS CUI [7,2]
    C0439801
    UMLS CUI [7,3]
    C0525058
    12. subjects must not be pregnant or nursing due to the potential for congenital abnormalities and the potential of this regimen to harm nursing infants.
    Descrizione

    Pregnancy | Breast Feeding

    Tipo di dati

    boolean

    Alias
    UMLS CUI [1]
    C0032961
    UMLS CUI [2]
    C0006147
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    Similar models

    Eligibility T1/2N0-2 Squamous Cell Carcinoma of the Head and Neck NCT02201355

    1 moduli
    Name
    genere
    Description | Question | Decode (Coded Value)
    Tipo di dati
    Alias
    Item Group
    C1512693 (UMLS CUI)
    Squamous cell carcinoma of oropharynx TNM clinical staging | Squamous cell carcinoma of the hypopharynx TNM clinical staging | Laryngeal Squamous Cell Carcinoma TNM clinical staging
    Item
    1. t1/2n0-2m0 scc of the oropharynx, hypopharynx or larynx
    boolean
    C0280313 (UMLS CUI [1,1])
    C3258246 (UMLS CUI [1,2])
    C0280321 (UMLS CUI [2,1])
    C3258246 (UMLS CUI [2,2])
    C0280324 (UMLS CUI [3,1])
    C3258246 (UMLS CUI [3,2])
    Age
    Item
    2. age ≥ 18 years.
    boolean
    C0001779 (UMLS CUI [1])
    ECOG performance status
    Item
    3. performance status ecog 0-1
    boolean
    C1520224 (UMLS CUI [1])
    Organ function | Bone Marrow function
    Item
    4. adequate organ and marrow function as determined by medical oncology evaluation.
    boolean
    C0678852 (UMLS CUI [1])
    C0005953 (UMLS CUI [2,1])
    C0031843 (UMLS CUI [2,2])
    Childbearing Potential Contraceptive methods | Gender Contraceptive methods | Hormonal contraception | Contraception, Barrier | Sexual Abstinence
    Item
    5. women of child-bearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry, for the duration of study participation, and for 90 days following completion of therapy. should a woman become pregnant or suspect she is pregnant while participating in this study, she should inform her treating physician immediately.
    boolean
    C3831118 (UMLS CUI [1,1])
    C0700589 (UMLS CUI [1,2])
    C0079399 (UMLS CUI [2,1])
    C0700589 (UMLS CUI [2,2])
    C2985296 (UMLS CUI [3])
    C0004764 (UMLS CUI [4])
    C0036899 (UMLS CUI [5])
    Childbearing Potential Criteria Fulfill | Independent of Sexual Orientation | Tubal Ligation | Sexual Abstinence
    Item
    6. a female of child-bearing potential is any woman (regardless of sexual orientation, having undergone a tubal ligation, or remaining celibate by choice) who meets the following criteria:
    boolean
    C3831118 (UMLS CUI [1,1])
    C0243161 (UMLS CUI [1,2])
    C1550543 (UMLS CUI [1,3])
    C0332291 (UMLS CUI [2,1])
    C0205949 (UMLS CUI [2,2])
    C0520483 (UMLS CUI [3])
    C0036899 (UMLS CUI [4])
    Hysterectomy Absent | Bilateral oophorectomy Absent
    Item
    has not undergone a hysterectomy or bilateral oophorectomy; or
    boolean
    C0020699 (UMLS CUI [1,1])
    C0332197 (UMLS CUI [1,2])
    C0278321 (UMLS CUI [2,1])
    C0332197 (UMLS CUI [2,2])
    Postmenopausal state Absent
    Item
    has not been naturally postmenopausal for at least 12 consecutive months (i.e., has had menses at any time in the preceding 12 consecutive months).
    boolean
    C0232970 (UMLS CUI [1,1])
    C0332197 (UMLS CUI [1,2])
    Informed Consent
    Item
    7 ability to understand and the willingness to sign a written informed consent.
    boolean
    C0021430 (UMLS CUI [1])
    Creatinine clearance measurement | 24 hour renal creatinine clearance | Estimation of creatinine clearance by Cockcroft-Gault formula
    Item
    8. creatinine clearance (cc) ≥ 50 ml/min within 4 weeks prior to registration determined by 24-hour collection or estimated by cockcroft-gault formula: ccr male = [(140 - age) x (wt in kg)]/[(serum cr mg/dl) x (72)] (ccr female = 0.85 x (crcl male)).
    boolean
    C0373595 (UMLS CUI [1])
    C4032392 (UMLS CUI [2])
    C2711451 (UMLS CUI [3])
    Medical History | Physical Examination | Assessment Body Weight | Assessment Weight loss
    Item
    9. history/physical examination within 4 weeks prior to registration, including assessment of weight and weight loss in past 6 months.
    boolean
    C0262926 (UMLS CUI [1])
    C0031809 (UMLS CUI [2])
    C1516048 (UMLS CUI [3,1])
    C0005910 (UMLS CUI [3,2])
    C1516048 (UMLS CUI [4,1])
    C1262477 (UMLS CUI [4,2])
    Medical oncology Examination | Evaluation Medical contraindication | DENTAL EVALUATION | Nutrition Evaluation | Consideration Percutaneous placement of gastrostomy tube | Distant metastasis Absent PET/CT scan
    Item
    10. medical oncology examination to evaluate medical contraindications prior to start chemotherapy 11 dental evaluation with management prior to start of radiation 12 nutrition evaluation with consideration of percutaneous endoscopic gastrostomy (peg) tube placement 13 no distant metastasis by pet/ct
    boolean
    C0025098 (UMLS CUI [1,1])
    C0582103 (UMLS CUI [1,2])
    C1261322 (UMLS CUI [2,1])
    C1301624 (UMLS CUI [2,2])
    C0011356 (UMLS CUI [3])
    C3825905 (UMLS CUI [4])
    C0518609 (UMLS CUI [5,1])
    C0192460 (UMLS CUI [5,2])
    C1269798 (UMLS CUI [6,1])
    C0332197 (UMLS CUI [6,2])
    C1699633 (UMLS CUI [6,3])
    Item Group
    C0680251 (UMLS CUI)
    Disease TNM clinical staging
    Item
    1. t3/4 or n3
    boolean
    C0012634 (UMLS CUI [1,1])
    C3258246 (UMLS CUI [1,2])
    Disease TNM clinical staging
    Item
    2. t1n0 disease
    boolean
    C0012634 (UMLS CUI [1,1])
    C3258246 (UMLS CUI [1,2])
    Neoplasm Metastasis
    Item
    3. metastatic disease
    boolean
    C0027627 (UMLS CUI [1])
    Invasive cancer | Exception Skin carcinoma | Exception Disease Free Duration
    Item
    4. prior invasive malignancy (except non-melanomatous skin cancer) unless disease free for a minimum of 3 years
    boolean
    C0677898 (UMLS CUI [1])
    C1705847 (UMLS CUI [2,1])
    C0699893 (UMLS CUI [2,2])
    C1705847 (UMLS CUI [3,1])
    C0012634 (UMLS CUI [3,2])
    C0332296 (UMLS CUI [3,3])
    C0449238 (UMLS CUI [3,4])
    Prior radiation therapy Region Clinical Trial Malignant Neoplasm | With result Overlap Radiation Field
    Item
    5. prior radiotherapy to the region of the study cancer that would result in overlap of radiation therapy fields
    boolean
    C0279134 (UMLS CUI [1,1])
    C0205147 (UMLS CUI [1,2])
    C0008976 (UMLS CUI [1,3])
    C0006826 (UMLS CUI [1,4])
    C0332294 (UMLS CUI [2,1])
    C1948020 (UMLS CUI [2,2])
    C1882536 (UMLS CUI [2,3])
    Primary tumor site Oral cavity | Primary tumor site Nasopharynx | Primary tumor site Sinuses | Primary tumor site Salivary Glands
    Item
    6. primary site of tumor of oral cavity, nasopharynx, sinuses, or salivary glands
    boolean
    C0475447 (UMLS CUI [1,1])
    C0226896 (UMLS CUI [1,2])
    C0475447 (UMLS CUI [2,1])
    C0027442 (UMLS CUI [2,2])
    C0475447 (UMLS CUI [3,1])
    C0030471 (UMLS CUI [3,2])
    C0475447 (UMLS CUI [4,1])
    C0036098 (UMLS CUI [4,2])
    Neck Adenopathy Involving Skin
    Item
    7. neck adenopathy that involves the overlying skin.
    boolean
    C0027530 (UMLS CUI [1,1])
    C0497156 (UMLS CUI [1,2])
    C1314939 (UMLS CUI [1,3])
    C1123023 (UMLS CUI [1,4])
    Operative Surgical Procedure Initial | Tonsillectomy | Neck Dissection | Exception Biopsy Primary tumor site | Exception Sampling of lymph node Disorder of neck
    Item
    8. initial surgical treatment including tonsillectomy or neck dissection, but excluding diagnostic biopsy of the primary site or nodal sampling of neck disease
    boolean
    C0543467 (UMLS CUI [1,1])
    C0205265 (UMLS CUI [1,2])
    C0040423 (UMLS CUI [2])
    C0398395 (UMLS CUI [3])
    C1705847 (UMLS CUI [4,1])
    C0005558 (UMLS CUI [4,2])
    C0475447 (UMLS CUI [4,3])
    C1705847 (UMLS CUI [5,1])
    C0398417 (UMLS CUI [5,2])
    C0558385 (UMLS CUI [5,3])
    Sensory neuropathy Pre-existing CTCAE Grades
    Item
    9. pre-existing grade > 2 peripheral sensory neuropathy
    boolean
    C0151313 (UMLS CUI [1,1])
    C2347662 (UMLS CUI [1,2])
    C1516728 (UMLS CUI [1,3])
    Investigational New Drugs
    Item
    10. subjects may not be receiving any other investigational agents.
    boolean
    C0013230 (UMLS CUI [1])
    Comorbidity Uncontrolled | Communicable Disease | Symptomatic congestive heart failure | Angina, Unstable | Cardiac Arrhythmia | Mental disorders Limiting Protocol Compliance | Social situation Limiting Protocol Compliance
    Item
    11. uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements.
    boolean
    C0009488 (UMLS CUI [1,1])
    C0205318 (UMLS CUI [1,2])
    C0009450 (UMLS CUI [2])
    C0742758 (UMLS CUI [3])
    C0002965 (UMLS CUI [4])
    C0003811 (UMLS CUI [5])
    C0004936 (UMLS CUI [6,1])
    C0439801 (UMLS CUI [6,2])
    C0525058 (UMLS CUI [6,3])
    C0748872 (UMLS CUI [7,1])
    C0439801 (UMLS CUI [7,2])
    C0525058 (UMLS CUI [7,3])
    Pregnancy | Breast Feeding
    Item
    12. subjects must not be pregnant or nursing due to the potential for congenital abnormalities and the potential of this regimen to harm nursing infants.
    boolean
    C0032961 (UMLS CUI [1])
    C0006147 (UMLS CUI [2])
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