ID

37283

Beskrivning

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

Länk

https://clinicaltrials.gov/show/NCT02201355

Nyckelord

Versioner (1)
  1. 2019-07-13 2019-07-13 -
Rättsinnehavare

See clinicaltrials.gov

Uppladdad den

13 juli 2019

DOI

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Licens

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

Engelsk

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

1 Formulär  
Inclusion Criteria
Beskrivning

Inclusion Criteria

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

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

Datatyp

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.
Beskrivning

Age

Datatyp

boolean

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

ECOG performance status

Datatyp

boolean

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

Organ function | Bone Marrow function

Datatyp

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.
Beskrivning

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

Datatyp

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:
Beskrivning

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

Datatyp

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
Beskrivning

Hysterectomy Absent | Bilateral oophorectomy Absent

Datatyp

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).
Beskrivning

Postmenopausal state Absent

Datatyp

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.
Beskrivning

Informed Consent

Datatyp

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)).
Beskrivning

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

Datatyp

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.
Beskrivning

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

Datatyp

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
Beskrivning

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

Datatyp

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
Beskrivning

Exclusion Criteria

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

Disease TNM clinical staging

Datatyp

boolean

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

Disease TNM clinical staging

Datatyp

boolean

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

Neoplasm Metastasis

Datatyp

boolean

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

Invasive cancer | Exception Skin carcinoma | Exception Disease Free Duration

Datatyp

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
Beskrivning

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

Datatyp

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
Beskrivning

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

Datatyp

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.
Beskrivning

Neck Adenopathy Involving Skin

Datatyp

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
Beskrivning

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

Datatyp

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
Beskrivning

Sensory neuropathy Pre-existing CTCAE Grades

Datatyp

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.
Beskrivning

Investigational New Drugs

Datatyp

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.
Beskrivning

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

Datatyp

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.
Beskrivning

Pregnancy | Breast Feeding

Datatyp

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 Formulär
Name
Typ
Description | Question | Decode (Coded Value)
Datatyp
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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