UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000004589 |
|---|---|
| Receipt number | R000005477 |
| Scientific Title | Phase I radiaition dose escalation study of intensity-modulated radiotherapy with end-exhalation breath-hold technique, combined with full-dose gemcitabine for patients with locally advanced pancreatic cancer. |
| Date of disclosure of the study information | 2010/11/19 |
| Last modified on | 2017/02/01 18:58:15 |
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Basic information
Public title
Phase I radiaition dose escalation study of intensity-modulated radiotherapy with end-exhalation breath-hold technique, combined with full-dose gemcitabine for patients with locally advanced pancreatic cancer.
Acronym
Breath-hold IMRT for pancreatic cancer: radiation dose escalation study
Scientific Title
Phase I radiaition dose escalation study of intensity-modulated radiotherapy with end-exhalation breath-hold technique, combined with full-dose gemcitabine for patients with locally advanced pancreatic cancer.
Scientific Title:Acronym
Breath-hold IMRT for pancreatic cancer: radiation dose escalation study
Region
| Japan |
Condition
Condition
Pancreatic cancer
Classification by specialty
| Hepato-biliary-pancreatic medicine | Radiology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To determine the maximum-tolerated radiation dose delivered with intensity-modulated radiotherapy under breath-hold technique at end-exhalation and concurrent full-dose gemcitabine, in patients with unresectable locally advanced pancreatic cancer.
Basic objectives2
Safety
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Phase I
Assessment
Primary outcomes
Safety (the incidence of dose limiting toxicity)
Key secondary outcomes
Local control rate, overall survival time, progression-free survival time, completion rate of chemotherapy, incidence of adverse events within 6 months from the start day of treatment, Rate of palliative efficacy (pain relief), rate of CA19-9 regression, The accuracy of the new technique of radiotherapy
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Medicine | Maneuver |
Interventions/Control_1
Intensity-modulated radiotherapy(IMRT)
Concurrent chemotherapy with Gemcitabine
Induction chemotherapy with Gemcitabine
Interventions/Control_2
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10
Eligibility
Age-lower limit
| 20 | years-old | <= |
Age-upper limit
| 80 | years-old | > |
Gender
Male and Female
Key inclusion criteria
1) Pancreatic cancer proven with pathological or cytological examination with diagnostic imaging.
2) Clinical stage (T3-4, N0, M0) (UICC), unresectable pancreatic cancer (medically inoperable T3 patients are also allowed on to this study
3) Patients have tumors measurable by RECIST criteria
4) Tumor size </= 6cm
5) Np apparent bowel invasion of tumors on CT or endscopic findings
6) Patients' age must be >/=18 and <80 years old. ECOG performance status; 0-1
7) Without history of previous chemotherapy, but patients who have received up to one cycle of single agent gemcitabine remain eligible.
8) Without history of previous abdominal radiation therapy
9) Adequate organ functions;
white blood cells >/= 3000/m3
neutrophil >=2000/m3
platelets >/= 100,000/m3
hemoglobin >/= 10.0g/dl
AST </= 3.0 X ULN
ALT </= 3.0 X ULN
total bilirubin </= 2.0mg/dL
10) Patients must be aware of the investigational nature of therapy and provide written informed consent.
Key exclusion criteria
1) Patients with active double cancer (double cancer with no more than 5-year disease-free period. However, carcinoma in situ judged to be cured by local treatment, or intra-mucosal cancer-equivalent lesion are not to be included in active double cancer).
2) Patients with active bacterial infection requiring treatment.
3) Patients with severe cardiac disease
4) Patients with severe drug allergy history
5) Patients with unstable and uncontrollable diabetic mellitus, hypertension, kidney disease, liver disease.
6) Patients with intersitial pneumonia or pulmonary fibrosis detectable on chest radiography
7) Women during pregnancy or breast-feeding, or patients who wish pregnancy
8) Patients that physicians consider inappropriate for this study.
Target sample size
18
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Masahiro Hiraoka |
Organization
Kyoto University Hospital
Division name
Therapeutic Radiology
Zip code
Address
54 Shogoin Kawaharacho Sakyo-ku, Kyoto
TEL
075-751-3762
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Keiko SHibuya |
Organization
Kyoto University Hospital
Division name
Therapeutic Radiology
Zip code
Address
54 Shogoin Kawaharacho Sakyo-ku, Kyoto
TEL
075-751-3762
Homepage URL
kei@kuhp.kyoto-u.ac.jp
Sponsor or person
Institute
Department of Therapeutic Radiology, Kyoto University Hospital
Institute
Department
Personal name
Funding Source
Organization
Ministry of Health, Labor and Welfare, Grant-in Aid for Cancer Research (20S-5)
Organization
Division
Category of Funding Organization
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Name of secondary funder(s)
Japan Society for the Promotion of Science (JSPS), Grant-in-Aid for Scientific Research (S)
IRB Contact (For public release)
Organization
Address
Tel
Secondary IDs
Secondary IDs
NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
京都大学医学部附属病院
Other administrative information
Date of disclosure of the study information
| 2010 | Year | 11 | Month | 19 | Day |
Related information
URL releasing protocol
Publication of results
Unpublished
Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
No longer recruiting
Date of protocol fixation
| 2010 | Year | 09 | Month | 08 | Day |
Date of IRB
Anticipated trial start date
| 2011 | Year | 01 | Month | 01 | Day |
Last follow-up date
| 2013 | Year | 06 | Month | 01 | Day |
Date of closure to data entry
| 2013 | Year | 12 | Month | 01 | Day |
Date trial data considered complete
| 2013 | Year | 12 | Month | 01 | Day |
Date analysis concluded
| 2013 | Year | 12 | Month | 01 | Day |
Other
Other related information
Management information
Registered date
| 2010 | Year | 11 | Month | 19 | Day |
Last modified on
| 2017 | Year | 02 | Month | 01 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000005477
