UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000063428 |
|---|---|
| Receipt number | R000072585 |
| Scientific Title | S-1-concurrent proton therapy for locally advanced pancreatic cancer: A single-institution prospective phase II clinical trial |
| Date of disclosure of the study information | 2026/10/27 |
| Last modified on | 2026/10/27 16:10:09 |
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Basic information
Public title
Evaluation of efficacy and safety of proton therapy for locally advanced pancreatic cancer
Acronym
Proton therapy for locally advanced pancreatic cancer
Scientific Title
S-1-concurrent proton therapy for locally advanced pancreatic cancer: A single-institution prospective phase II clinical trial
Scientific Title:Acronym
S-1-concurrent proton therapy for locally advanced pancreatic cancer: A single-institution prospective phase II clinical trial
Region
| Japan |
Condition
Condition
Locally advanced pancreatic cancer
Classification by specialty
| Hepato-biliary-pancreatic medicine | Radiology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the efficacy and safety of definitive proton beam therapy with concurrent S-1 in patients with locally advanced pancreatic cancer.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Overall survival
Key secondary outcomes
Distant metastasis-free survival (DMFS); progression-free survival (PFS); local control rate (LCR); carbohydrate antigen 19-9 (CA19-9) response rate; incidence of adverse events (AEs); incidence of late adverse events; incidence of treatment-related death / Grade 4 non-hematologic toxicity.
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Historical
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Maneuver |
Interventions/Control_1
S-1-concurrent moderately hypofractionated proton therapy
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) adenocarcinoma confirmed on histology or cytology
2) absence of distant metastasis
3) T4, according to the 7th edition of the TNM staging system of the Union for International Cancer Control
4) age >= 20 and <= 80 years
5) no visible pleural effusion or ascites by computed tomography (CT)
6) no active gastroduodenal ulcer
7) no evidence of direct invasion of gastrointestinal (GI) tracts by upper GI endoscopy and CT
8) Eastern Cooperative Oncology Group performance status of 0-1
9) no history of surgery for pancreatic cancer (PC)
10) no history of chemotherapy and radiotherapy for PC
11) satisfactory hematological functions (leukocyte count, >= 3500/mm3; hemoglobin concentration, >= 9.0 g/dl; platelet count, >= 100,000/mm3); adequate hepatic function (serum albumin >= 3.0 g/dl; total bilirubin, <= 2.0 [3.0 in patients with biliary drainage] mg/dL; AST, <= 100 [150 in patients with biliary drainage] IU/L; ALT, <= 100 [150 in patients with biliary drainage] IU/L); and normal renal function (serum creatinine, <= 1.2 mg/dL or creatinine clearance, >= 50 mL/min)
12) written informed consent
Key exclusion criteria
1) apparent interstitial pneumonitis or pulmonary fibrosis detectable by chest X-ray radiography
2) severe watery diarrhea
3) severe comorbidities, such as renal or cardiac disease
4) flucytosine, phenytoin, or warfarin potassium treatment
5) active concomitant malignancy
6) active infection
7) pregnant and lactating women or women of childbearing age, or men with a partner who wishes to become pregnant
8) severe psychological disorder
9) requiring continuous systemic steroid medication
10) allergy to the iodine and gadolinium agents used in contrast-enhanced imaging
11) presence of a metallic stent in the common bile duct
12) other causes judged as unsuitable for participation by the investigators
Target sample size
22
Research contact person
Name of lead principal investigator
| 1st name | Hiroyuki |
| Middle name | |
| Last name | Ogino |
Organization
Nagoya City University West Medical Center
Division name
Nagoya Proton Therapy Center
Zip code
462-8508
Address
1-1-1, Hirate-cho, Kita-ku, Nagoya, Aichi
TEL
052-991-8577
oginogio@gmail.com
Public contact
Name of contact person
| 1st name | Koichiro |
| Middle name | |
| Last name | Nakajima |
Organization
Nagoya City University West Medical Center
Division name
Nagoya Proton Therapy Center
Zip code
462-8508
Address
1-1-1, Hirate-cho, Kita-ku, Nagoya, Aichi
TEL
052-991-8577
Homepage URL
k.nakajima.ncu@gmail.com
Sponsor or person
Institute
Nagoya City University West Medical Center
Institute
Department
Personal name
Funding Source
Organization
None
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Clinical Study Committees of the Nagoya City Hospital
Address
1-2-23 Wakamizu, Chikusa-ku, Nagoya-city, Aichi
Tel
052-721-7171
westirb@med.nagoya-cu.ac.jp
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
Other administrative information
Date of disclosure of the study information
| 2026 | Year | 10 | Month | 27 | Day |
Related information
URL releasing protocol
Under review
Publication of results
Unpublished
Result
URL related to results and publications
Under review
Number of participants that the trial has enrolled
22
Results
Median follow-up was 18 months (range, 6-45). Median OS and PFS were 18 months (95% CI, 13-25) and 8.5 months (95% CI, 4-15), respectively. The 1- and 2-year OS rates were 77% and 36%, respectively, and the 1-year PFS rate was 41%. No patients underwent surgery for the primary tumor. No grade >=3 hematologic toxicity occurred during CCPT. After CCPT, grade 3 anemia and grade >=3 GI ulcers occurred in 7 (32%) and 2 patients (10%), respectively.
Results date posted
| 2026 | Year | 10 | Month | 27 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
A total of 22 patients were enrolled. The median age was 72 years (range, 50-79 years), and 10 patients (45%) were male. Eastern Cooperative Oncology Group performance status was 0 in 20 patients (91%) and 1 in 2 patients (9%). Tumors were located in the pancreatic head in 11 patients (50%) and in the body or tail in 11 patients (50%). The median tumor size was 37.5 mm (range, 23-79 mm), and the median serum CA19-9 level was 420 U/mL (range, 0-16,574 U/mL). Nodal status was N0 in 19 patients (86%) and N1 in 3 patients (14%).
Bile duct invasion, venous invasion, gastroduodenal invasion, anterior peripancreatic invasion, and posterior peripancreatic invasion were observed in 4 (18%), 12 (55%), 8 (36%), 18 (82%), and 22 patients (100%), respectively. Four patients (18%) had biliary stents. The median gross tumor volume and clinical target volume were 47 cm3 (range, 18-89 cm3) and 155 cm3 (range, 47-307 cm3), respectively.
Participant flow
A total of 22 eligible patients with LAPC were registered between February 2015 and March 2018.
Adverse events
During the CCPT period, grade 3 or higher hematologic toxicity was not observed. Regarding non-hematological toxicity, grade 3 anorexia occurred in one patient (5%), who was hospitalized for three days. After CCPT, grade 3 anemia occurred in seven patients (32%) during S-1 maintenance chemotherapy. Grade 3 or higher GI ulcer occurred in two patients (10%). Both patients received blood transfusion, and one patient, who was diagnosed with a grade 4 duodenal ulcer, received transarterial embolization. Grade 3 duodenal obstruction occurred in one patient (5%), who received endoscopic metallic stent placement.
Outcome measures
The primary endpoint was OS. Secondary endpoints included distant metastasis-free survival (DMFS), progression-free survival (PFS), LC, serum carbohydrate antigen 19-9 (CA19-9) level response, and incidence of adverse events (AEs).
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
No longer recruiting
Date of protocol fixation
| 2014 | Year | 12 | Month | 01 | Day |
Date of IRB
| 2014 | Year | 12 | Month | 03 | Day |
Anticipated trial start date
| 2014 | Year | 12 | Month | 15 | Day |
Last follow-up date
| 2021 | Year | 11 | Month | 30 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2026 | Year | 10 | Month | 27 | Day |
Last modified on
| 2026 | Year | 10 | Month | 27 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000072585
