ID

45880

Description

CombiCaRe Protocol of a prospective, monocentric phase I/II feasibility study investigating the safety of multimodality treatment with a combination of intraoperative chemotherapy and surgical resection in locally confined or borderline resectable pancreatic cancer: the combiCaRe study. Roth S, Springfeld C, Diener MK, Tjaden C, Knebel P, Klaiber U, Michalski CW, Mieth M, Jäger D, Büchler MW, Hackert T.

Mots-clés

Versions (1)
  1. 10/11/2023 10/11/2023 - Nelly Zental
Détendeur de droits

Roth S, Springfeld C, Diener MK, Tjaden C, Knebel P, Klaiber U, Michalski CW, Mieth M, Jäger D, Büchler MW, Hackert T.

Téléchargé le

10 novembre 2023

DOI

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Licence

Creative Commons BY 4.0
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CombiCaRe study

Anglais

Intervention

12 Formulaires  
  1. StudyEvent: combicare trial
    1. Screening
    2. Intervention
    3. POD 3
    4. POD 7
    5. POD 14 / Discharge
    6. POD 30
    7. POD 60/Discontinuation
    8. Signature
  2. StudyEvent: Readmission To Hospital
    1. Readmission To Hospital
  3. StudyEvent: Adverse Events
    1. Adverse Events
  4. StudyEvent: Concomitant Medication
    1. Concomitant Medication
  5. StudyEvent: Protocol Violation
    1. Protocol violation
5-FU treatment
Description

5-FU treatment

Alias
UMLS CUI [1,1]
C0016360
UMLS CUI [1,2]
C1533734
Start of 5-FU chemotherapy (date)
Description

Start 5-FU date

Type de données

date

Alias
UMLS CUI [1,1]
C0808070
UMLS CUI [1,2]
C0016360
UMLS CUI [1,3]
C0392920
Start of 5-FU chemotherapy (time)
Description

Start 5-FU time

Type de données

time

Alias
UMLS CUI [1,1]
C1301880
UMLS CUI [1,2]
C0016360
UMLS CUI [1,3]
C0392920
Planned dose of 5-FU chemotherapy
Description

Planned dose 5-FU

Type de données

float

Unités de mesure
  • mg
Alias
UMLS CUI [1,1]
C2826283
mg
Modification of planned 5-FU dose?
Description

Modification 5-FU dose

Type de données

boolean

Alias
UMLS CUI [1,1]
C1707811
Reason for 5-FU dose modification
Description

Reason modification

Type de données

text

Alias
UMLS CUI [1,1]
C0392360
If other, please specify
Description

specify reason

Type de données

text

Alias
UMLS CUI [1,1]
C0205394
UMLS CUI [1,2]
C1521902
Dose administered
Description

Dose administered

Type de données

float

Unités de mesure
  • mg
Alias
UMLS CUI [1,1]
C2348343
mg
End of 5-FU chemotherapy (date)
Description

End 5-FU date

Type de données

date

Alias
UMLS CUI [1,1]
C0806020
UMLS CUI [1,2]
C0016360
UMLS CUI [1,3]
C0392920
End of 5-FU chemotherapy (time)
Description

End 5-FU time

Type de données

time

Alias
UMLS CUI [1,1]
C1522314
UMLS CUI [1,2]
C0016360
UMLS CUI [1,3]
C0392920
Calcium folinate and Granisetron treatment
Description

Calcium folinate and Granisetron treatment

Alias
UMLS CUI [1,1]
C0061863
UMLS CUI [2,1]
C0023413
Modification of planned Calcium folinate treatment?
Description

Modification Calcium folinate

Type de données

boolean

Alias
UMLS CUI [1,1]
C1299575
UMLS CUI [1,2]
C0023413
Reason for Calcium folinate dose modification
Description

Reason modification

Type de données

text

Alias
UMLS CUI [1,1]
C0392360
If other, please specify
Description

specify reason

Type de données

text

Alias
UMLS CUI [1,1]
C0205394
UMLS CUI [1,2]
C1521902
Modification of planned Granisetron treatment?
Description

Modification Granisetron

Type de données

boolean

Alias
UMLS CUI [1,1]
C1299575
UMLS CUI [1,2]
C0061863
If yes, please specify discrepancy
Description

specify discrepancy

Type de données

text

Alias
UMLS CUI [1,1]
C1521902
UMLS CUI [1,2]
C3840684)
Surgery
Description

Surgery

Alias
UMLS CUI [1,1]
C0543467
Date of surgery
Description

Date of surgery

Type de données

date

Alias
UMLS CUI [1,1]
C0011008
UMLS CUI [1,2]
C0543467
Intraoperative re-evaluation of resectability
Description

Intraoperative re-evaluation of resectability

Alias
UMLS CUI [1,1]
C0456904
UMLS CUI [1,2]
C0681840
UMLS CUI [1,3]
C5396338
Result of intraoperative re-evaluation of resectability
Description

Result re-evaluation

Type de données

text

Alias
UMLS CUI [1,1]
C1274040
UMLS CUI [1,2]
C0456904
UMLS CUI [1,3]
C0681840
UMLS CUI [1,4]
C5396338
Exclusion of liver metastasis
Description

Exclusion of liver metastasis

Type de données

boolean

Alias
UMLS CUI [1,1]
C2828389
UMLS CUI [1,2]
C0494165
Exclusion of peritoneal carcinomatosis
Description

Exclusion of peritoneal carcinomatosis

Type de données

boolean

Alias
UMLS CUI [1,1]
C2828389
UMLS CUI [1,2]
C0346990
Exclusion of superior mesenteric / hepatic artery encasement
Description

Exclusion of superior mesenteric / hepatic artery encasement

Type de données

boolean

Alias
UMLS CUI [1,1]
C2828389
UMLS CUI [1,2]
C4524504
UMLS CUI [1,3]
C0019145
UMLS CUI [1,4]
C0162861
Tumor location (pancreas)
Description

Tumor location (pancreas)

Alias
UMLS CUI [1,1]
C2063875
uncinate process
Description

uncinate process

Type de données

boolean

Alias
UMLS CUI [1,1]
C0227580
head
Description

head

Type de données

boolean

Alias
UMLS CUI [1,1]
C0227579
body
Description

body

Type de données

boolean

Alias
UMLS CUI [1,1]
C0227582
tail
Description

tail

Type de données

boolean

Alias
UMLS CUI [1,1]
C0227590
Surgery Details
Description

Surgery Details

Alias
UMLS CUI [1,1]
C5204320
Start skin incision (time)
Description

Start

Type de données

time

Alias
UMLS CUI [1,1]
C0191279
UMLS CUI [1,2]
C1301880
End of surgery (time)
Description

End

Type de données

time

Alias
UMLS CUI [1,1]
C1522314
UMLS CUI [1,2]
C0543467
Performed surgical intervention
Description

surgical intervention

Type de données

text

Alias
UMLS CUI [1,1]
C4035998
If other, please specify
Description

specify surgical intervention

Type de données

text

Alias
UMLS CUI [1,1]
C1521902
Additional resections
Description

Additional resections

Alias
UMLS CUI [1,1]
C1524062
UMLS CUI [1,2]
C0015252
Vascular (venous) resections and reconstructions
Description

Vascular resections

Type de données

boolean

Alias
UMLS CUI [1,1]
C0189617
Vascular (venous) resections and reconstructions
Description

Vascular (venous) resections and reconstructions

Alias
UMLS CUI [1,1]
C0189617
portal venous resection
Description

portal venous resection

Type de données

boolean

Alias
UMLS CUI [1,1]
C0226727
UMLS CUI [1,2]
C00152526
VMS resection
Description

VMS resection

Type de données

boolean

Alias
UMLS CUI [1,1]
C0226742
UMLS CUI [1,2]
C0015252
other
Description

other

Type de données

boolean

Alias
UMLS CUI [1,1]
C0205394
If other vascular resection, please specify
Description

specify vascular resections

Type de données

text

Alias
UMLS CUI [1,1]
C1521902
Additional resections
Description

Additional resections

Alias
UMLS CUI [1,1]
C1524062
UMLS CUI [1,2]
C0015252
Additional resections
Description

Additional resections

Type de données

boolean

Alias
UMLS CUI [1,1]
C1706712
UMLS CUI [1,2]
C0015252
If yes, please specify additional resections
Description

If yes, please specify additional resections

Alias
UMLS CUI [1,1]
C1521902
lymphadenectomy
Description

lymphadenectomy

Type de données

boolean

Alias
UMLS CUI [1,1]
C0024203
extrapancreatic resections
Description

extrapancreatic resections

Type de données

boolean

Alias
UMLS CUI [1,1]
C0015252
UMLS CUI [1,2]
C0332300
UMLS CUI [1,3]
C0030274
other
Description

other

Type de données

boolean

Alias
UMLS CUI [1,1]
C0205394
If extrapancreatic resection, please specify
Description

specify extrapancreatic resection

Type de données

text

Alias
UMLS CUI [1,1]
C1521902
If other, please specify
Description

specify other

Type de données

text

Alias
UMLS CUI [1,1]
C1521902
Blood loss and Transfusion
Description

Blood loss and Transfusion

Alias
UMLS CUI [1,1]
C3163616
UMLS CUI [1,2]
C0005841
Intraoperative blood loss (as estimated from the anesthesia protocol)
Description

Intraoperative blood loss

Type de données

boolean

Alias
UMLS CUI [1,1]
C5208110
If yes, please specify
Description

specify blood loss

Type de données

float

Unités de mesure
  • ml
Alias
UMLS CUI [1,1]
C1521902
ml
Blood transfusion
Description

Blood transfusion

Type de données

boolean

Alias
UMLS CUI [1,1]
C0005841
Type of blood transfusion
Description

Type of blood transfusion

Alias
UMLS CUI [1,1]
C5420007
red blood cell concentrates
Description

red blood cell concentrates

Type de données

boolean

Alias
UMLS CUI [1,1]
C0086252
Volume of red blood cell concentrates
Description

Volume red blood cell concentrates

Type de données

float

Unités de mesure
  • ml
Alias
UMLS CUI [1,1]
C0086252
UMLS CUI [1,2]
C1264726
ml
fresh frozen plasma (FFP)
Description

fresh frozen plasma (FFP)

Type de données

boolean

Alias
UMLS CUI [1,1]
C1293883
Volume of fresh frozen plasma (FFP)
Description

Volume FFPs

Type de données

float

Unités de mesure
  • ml
Alias
UMLS CUI [1,1]
C1293883
UMLS CUI [1,2]
C1264726
ml
thrombocyte concentrates
Description

thrombocyte concentrates

Type de données

boolean

Alias
UMLS CUI [1,1]
C1293886
Volume of thrombocyte concentrates
Description

Volume thrombocyte concentrates

Type de données

float

Unités de mesure
  • ml
Alias
UMLS CUI [1,1]
C1293886
UMLS CUI [1,2]
C1264726
ml
Translational Studies
Description

Translational Studies

Alias
UMLS CUI [1,1]
C1519620
Blood sample taken (portal vein and peripheral vein)
Description

Blood sample

Type de données

boolean

Alias
UMLS CUI [1,1]
C1277698
UMLS CUI [1,2]
C2324289
UMLS CUI [1,3]
C5401001
Bone marrow sample taken
Description

Bone marrow

Type de données

boolean

Alias
UMLS CUI [1,1]
C0005954
Tumor tissue sample taken
Description

Tumor tissue

Type de données

boolean

Alias
UMLS CUI [1,1]
C0475358
Concomitant Medication
Description

Concomitant Medication

Alias
UMLS CUI [1,1]
C2347852
Any changes in Concomitant Medication (since last visit)?
Description

changes in Concomitant Medication

Type de données

boolean

Alias
UMLS CUI [1,1]
C3872643
UMLS CUI [1,2]
C0392747
If yes, please fill out eForm 'Concomitant Medication'
Description

If yes, please fill out eForm 'Concomitant Medication'

Alias
UMLS CUI [1,1]
C3273494
UMLS CUI [1,2]
C2347852
Adverse Events
Description

Adverse Events

Alias
UMLS CUI [1,1]
C0877248
Any Adverse Events occurred since last visit?
Description

Adverse Events occurred

Type de données

boolean

Alias
UMLS CUI [1,1]
C3872643
If yes, please fill out eForm 'Adverse Events'
Description

If yes, please fill out eForm 'Adverse Events'

Alias
UMLS CUI [1,1]
C0877248
UMLS CUI [1,2]
C3273494
Protocol violations
Description

Protocol violations

Alias
UMLS CUI [1,1]
C1709750
Any protocol violations occurred since last visit?
Description

protocol violations occurred

Type de données

boolean

Alias
UMLS CUI [1,1]
C3872643
If yes, please fill out eForm 'Protocol Violation'
Description

If yes, please fill out eForm 'Protocol Violation'

Alias
UMLS CUI [1,1]
C3273494
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Intervention

12 Formulaires
  1. StudyEvent: combicare trial
    1. Screening
    2. Intervention
    3. POD 3
    4. POD 7
    5. POD 14 / Discharge
    6. POD 30
    7. POD 60/Discontinuation
    8. Signature
  2. StudyEvent: Readmission To Hospital
    1. Readmission To Hospital
  3. StudyEvent: Adverse Events
    1. Adverse Events
  4. StudyEvent: Concomitant Medication
    1. Concomitant Medication
  5. StudyEvent: Protocol Violation
    1. Protocol violation
Name
Type
Description | Question | Decode (Coded Value)
Type de données
Alias
Item Group
5-FU treatment
C0016360 (UMLS CUI [1,1])
C1533734 (UMLS CUI [1,2])
Start 5-FU date
Item
Start of 5-FU chemotherapy (date)
date
C0808070 (UMLS CUI [1,1])
C0016360 (UMLS CUI [1,2])
C0392920 (UMLS CUI [1,3])
Start 5-FU time
Item
Start of 5-FU chemotherapy (time)
time
C1301880 (UMLS CUI [1,1])
C0016360 (UMLS CUI [1,2])
C0392920 (UMLS CUI [1,3])
Planned dose 5-FU
Item
Planned dose of 5-FU chemotherapy
float
C2826283 (UMLS CUI [1,1])
Modification 5-FU dose
Item
Modification of planned 5-FU dose?
boolean
C1707811 (UMLS CUI [1,1])
Item
Reason for 5-FU dose modification
text
C0392360 (UMLS CUI [1,1])
CL.10
Code List
Reason for 5-FU dose modification
CL Item
toxicity (1)
C0013221 (UMLS CUI [1,1])
CL Item
allergy (2)
C0013182 (UMLS CUI [1,1])
CL Item
other (3)
C0205394 (UMLS CUI [1,1])
specify reason
Item
If other, please specify
text
C0205394 (UMLS CUI [1,1])
C1521902 (UMLS CUI [1,2])
Dose administered
Item
Dose administered
float
C2348343 (UMLS CUI [1,1])
End 5-FU date
Item
End of 5-FU chemotherapy (date)
date
C0806020 (UMLS CUI [1,1])
C0016360 (UMLS CUI [1,2])
C0392920 (UMLS CUI [1,3])
End 5-FU time
Item
End of 5-FU chemotherapy (time)
time
C1522314 (UMLS CUI [1,1])
C0016360 (UMLS CUI [1,2])
C0392920 (UMLS CUI [1,3])
Item Group
Calcium folinate and Granisetron treatment
C0061863 (UMLS CUI [1,1])
C0023413 (UMLS CUI [2,1])
Modification Calcium folinate
Item
Modification of planned Calcium folinate treatment?
boolean
C1299575 (UMLS CUI [1,1])
C0023413 (UMLS CUI [1,2])
Item
Reason for Calcium folinate dose modification
text
C0392360 (UMLS CUI [1,1])
CL.10
Code List
Reason for Calcium folinate dose modification
CL Item
toxicity (1)
C0013221 (UMLS CUI [1,1])
CL Item
allergy (2)
C0013182 (UMLS CUI [1,1])
CL Item
other (3)
C0205394 (UMLS CUI [1,1])
specify reason
Item
If other, please specify
text
C0205394 (UMLS CUI [1,1])
C1521902 (UMLS CUI [1,2])
Modification Granisetron
Item
Modification of planned Granisetron treatment?
boolean
C1299575 (UMLS CUI [1,1])
C0061863 (UMLS CUI [1,2])
specify discrepancy
Item
If yes, please specify discrepancy
text
C1521902 (UMLS CUI [1,1])
C3840684) (UMLS CUI [1,2])
Item Group
Surgery
C0543467 (UMLS CUI [1,1])
Date of surgery
Item
Date of surgery
date
C0011008 (UMLS CUI [1,1])
C0543467 (UMLS CUI [1,2])
Item Group
Intraoperative re-evaluation of resectability
C0456904 (UMLS CUI [1,1])
C0681840 (UMLS CUI [1,2])
C5396338 (UMLS CUI [1,3])
Item
Result of intraoperative re-evaluation of resectability
text
C1274040 (UMLS CUI [1,1])
C0456904 (UMLS CUI [1,2])
C0681840 (UMLS CUI [1,3])
C5396338 (UMLS CUI [1,4])
CL.11
Code List
Result of intraoperative re-evaluation of resectability
CL Item
intraoperative eligibility (1)
C0013893 (UMLS CUI [1,1])
C0456904 (UMLS CUI [1,2])
CL Item
violation of intraoperative eligibility (2)
C1709750 (UMLS CUI [1,1])
C0456904 (UMLS CUI [1,2])
C0013893 (UMLS CUI [1,3])
Exclusion of liver metastasis
Item
Exclusion of liver metastasis
boolean
C2828389 (UMLS CUI [1,1])
C0494165 (UMLS CUI [1,2])
Exclusion of peritoneal carcinomatosis
Item
Exclusion of peritoneal carcinomatosis
boolean
C2828389 (UMLS CUI [1,1])
C0346990 (UMLS CUI [1,2])
Exclusion of superior mesenteric / hepatic artery encasement
Item
Exclusion of superior mesenteric / hepatic artery encasement
boolean
C2828389 (UMLS CUI [1,1])
C4524504 (UMLS CUI [1,2])
C0019145 (UMLS CUI [1,3])
C0162861 (UMLS CUI [1,4])
Item Group
Tumor location (pancreas)
C2063875 (UMLS CUI [1,1])
uncinate process
Item
uncinate process
boolean
C0227580 (UMLS CUI [1,1])
head
Item
head
boolean
C0227579 (UMLS CUI [1,1])
body
Item
body
boolean
C0227582 (UMLS CUI [1,1])
tail
Item
tail
boolean
C0227590 (UMLS CUI [1,1])
Item Group
Surgery Details
C5204320 (UMLS CUI [1,1])
Start
Item
Start skin incision (time)
time
C0191279 (UMLS CUI [1,1])
C1301880 (UMLS CUI [1,2])
End
Item
End of surgery (time)
time
C1522314 (UMLS CUI [1,1])
C0543467 (UMLS CUI [1,2])
Item
Performed surgical intervention
text
C4035998 (UMLS CUI [1,1])
CL.12
Code List
Performed surgical intervention
CL Item
partial pancreaticoduodenectomy (1)
C0728938 (UMLS CUI [1,1])
C0085162 (UMLS CUI [1,2])
CL Item
total pancreaticoduodenectomy (2)
C2945589 (UMLS CUI [1,1])
CL Item
pancreatic left resection (3)
C0400472 (UMLS CUI [1,1])
CL Item
other (4)
C0205394 (UMLS CUI [1,1])
specify surgical intervention
Item
If other, please specify
text
C1521902 (UMLS CUI [1,1])
Item Group
Additional resections
C1524062 (UMLS CUI [1,1])
C0015252 (UMLS CUI [1,2])
Vascular resections
Item
Vascular (venous) resections and reconstructions
boolean
C0189617 (UMLS CUI [1,1])
Item Group
Vascular (venous) resections and reconstructions
C0189617 (UMLS CUI [1,1])
portal venous resection
Item
portal venous resection
boolean
C0226727 (UMLS CUI [1,1])
C00152526 (UMLS CUI [1,2])
VMS resection
Item
VMS resection
boolean
C0226742 (UMLS CUI [1,1])
C0015252 (UMLS CUI [1,2])
other
Item
other
boolean
C0205394 (UMLS CUI [1,1])
specify vascular resections
Item
If other vascular resection, please specify
text
C1521902 (UMLS CUI [1,1])
Item Group
Additional resections
C1524062 (UMLS CUI [1,1])
C0015252 (UMLS CUI [1,2])
Additional resections
Item
Additional resections
boolean
C1706712 (UMLS CUI [1,1])
C0015252 (UMLS CUI [1,2])
Item Group
If yes, please specify additional resections
C1521902 (UMLS CUI [1,1])
lymphadenectomy
Item
lymphadenectomy
boolean
C0024203 (UMLS CUI [1,1])
extrapancreatic resections
Item
extrapancreatic resections
boolean
C0015252 (UMLS CUI [1,1])
C0332300 (UMLS CUI [1,2])
C0030274 (UMLS CUI [1,3])
other
Item
other
boolean
C0205394 (UMLS CUI [1,1])
specify extrapancreatic resection
Item
If extrapancreatic resection, please specify
text
C1521902 (UMLS CUI [1,1])
specify other
Item
If other, please specify
text
C1521902 (UMLS CUI [1,1])
Item Group
Blood loss and Transfusion
C3163616 (UMLS CUI [1,1])
C0005841 (UMLS CUI [1,2])
Intraoperative blood loss
Item
Intraoperative blood loss (as estimated from the anesthesia protocol)
boolean
C5208110 (UMLS CUI [1,1])
specify blood loss
Item
If yes, please specify
float
C1521902 (UMLS CUI [1,1])
Blood transfusion
Item
Blood transfusion
boolean
C0005841 (UMLS CUI [1,1])
Item Group
Type of blood transfusion
C5420007 (UMLS CUI [1,1])
red blood cell concentrates
Item
red blood cell concentrates
boolean
C0086252 (UMLS CUI [1,1])
Volume red blood cell concentrates
Item
Volume of red blood cell concentrates
float
C0086252 (UMLS CUI [1,1])
C1264726 (UMLS CUI [1,2])
fresh frozen plasma (FFP)
Item
fresh frozen plasma (FFP)
boolean
C1293883 (UMLS CUI [1,1])
Volume FFPs
Item
Volume of fresh frozen plasma (FFP)
float
C1293883 (UMLS CUI [1,1])
C1264726 (UMLS CUI [1,2])
thrombocyte concentrates
Item
thrombocyte concentrates
boolean
C1293886 (UMLS CUI [1,1])
Volume thrombocyte concentrates
Item
Volume of thrombocyte concentrates
float
C1293886 (UMLS CUI [1,1])
C1264726 (UMLS CUI [1,2])
Item Group
Translational Studies
C1519620 (UMLS CUI [1,1])
Blood sample
Item
Blood sample taken (portal vein and peripheral vein)
boolean
C1277698 (UMLS CUI [1,1])
C2324289 (UMLS CUI [1,2])
C5401001 (UMLS CUI [1,3])
Bone marrow
Item
Bone marrow sample taken
boolean
C0005954 (UMLS CUI [1,1])
Tumor tissue
Item
Tumor tissue sample taken
boolean
C0475358 (UMLS CUI [1,1])
Item Group
Concomitant Medication
C2347852 (UMLS CUI [1,1])
changes in Concomitant Medication
Item
Any changes in Concomitant Medication (since last visit)?
boolean
C3872643 (UMLS CUI [1,1])
C0392747 (UMLS CUI [1,2])
Item Group
If yes, please fill out eForm 'Concomitant Medication'
C3273494 (UMLS CUI [1,1])
C2347852 (UMLS CUI [1,2])
Item Group
Adverse Events
C0877248 (UMLS CUI [1,1])
Adverse Events occurred
Item
Any Adverse Events occurred since last visit?
boolean
C3872643 (UMLS CUI [1,1])
Item Group
If yes, please fill out eForm 'Adverse Events'
C0877248 (UMLS CUI [1,1])
C3273494 (UMLS CUI [1,2])
Item Group
Protocol violations
C1709750 (UMLS CUI [1,1])
protocol violations occurred
Item
Any protocol violations occurred since last visit?
boolean
C3872643 (UMLS CUI [1,1])
Item Group
If yes, please fill out eForm 'Protocol Violation'
C3273494 (UMLS CUI [1,1])
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