UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	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.
Title of the study (Brief title)	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	Masahiro Hiraoka
Organization	Kyoto University Hospital
Division name	Therapeutic Radiology
Address	54 Shogoin Kawaharacho Sakyo-ku, Kyoto
TEL	075-751-3762
Email

Public contact
Name of contact person	Keiko SHibuya
Organization	Kyoto University Hospital
Division name	Therapeutic Radiology
Address	54 Shogoin Kawaharacho Sakyo-ku, Kyoto
TEL	075-751-3762
Homepage URL
Email	kei@kuhp.kyoto-u.ac.jp

Sponsor
Institute	Department of Therapeutic Radiology, Kyoto University Hospital
Institute
Department

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)

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

Progress
Recruitment status	No longer recruiting
Date of protocol fixation	2010 Year 09 Month 08 Day
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

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
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
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000005477