UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000015530 |
|---|---|
| Receipt number | R000018039 |
| Scientific Title | A Phase II trial of preoperative chemoradiation therapy with S-1 for locally-advanced rectal cancer |
| Date of disclosure of the study information | 2014/12/01 |
| Last modified on | 2018/11/21 14:02:59 |
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Basic information
Public title
A Phase II trial of preoperative chemoradiation therapy with S-1 for locally-advanced rectal cancer
Acronym
Preoperative chemoradiation therapy with S-1 for locally-advanced rectal cancer
Scientific Title
A Phase II trial of preoperative chemoradiation therapy with S-1 for locally-advanced rectal cancer
Scientific Title:Acronym
Preoperative chemoradiation therapy with S-1 for locally-advanced rectal cancer
Region
| Japan |
Condition
Condition
locally advanced rectal cancer (T3-4, N0-2, M0)
Classification by specialty
| Gastroenterology | Surgery in general | Gastrointestinal surgery |
| Radiology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To evaluate safet and efficacy of preoperative chemoradiation therapy with S-1 (2 weeks administration and 1 week withdrawal) for locally advanced rectal cancer
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
safety (incidence and grades of adverse events for preoperative chemoradiation therapy)
Key secondary outcomes
RFS, OS, accumulated local recurrence rate, treatment completion rate, R0 resection rate, down-stagingrate, pathological response rate, response rate (RECIST version1.1), pCR, nutritional assessment, immunohistochemical assessment, safety (operative complications, late adverse events).
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 |
Interventions/Control_1
S-1: 80mg/m2/day, 2 weeks administration followed by 1 week withdrawl and 2 weeks administration, for a total of 5 weeks.
Radiationa therapy: 1.8 Gy/day, 5 days/week (through Monday to Friday), a total of 45 Gy/5 weeks.
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) Pathologically diagnosed as adenocarcinoma.
2) Patients who satisfy the following criteria within 28 days before registration:
* Patients with tumors in T3-4 and N0-2 according to the Japanese Classification of Colorectal Carcinoma, the 2nd edition and resectable.
* The tumor is mainly located in Ra, Rb or P according to the Japanese Classification of Colorectal Carcinoma, the 2nd edition.
* The anal margin of the tumor is lower than the level of peritoneal inversion.
* The tumor is not macroscopically classified into type 4.
* Diagnosed with colonoscopy, barium enema, contrast CT and contrast MRI. If the patient is allergic to contrast, plain CT and MRI are allowed.
* The distance between anal verge and the lower margin of the tumor should be recorded.
3) patients should be free from liver metastasis, peritoneal dissemination or distant metastasis.
4) Between 20 years old and 80 years old when registered.
5) Performance Status (ECOG) is 0-1.
6) No prior radiotherapy, chemotherapy or hormone therapy.
7) No severe disorder of bone marrow, heart, lung, liver or kidney. The data of blood test within 14 days before registration should be within the following range:
WBC counts: 12,000/mm3 > and > 3,000 /mm3
Neutrophil counts: > 1,500 / mm3
Platelet counts: > 75,000 /mm3
Hemoglobin: > 9.0 g/dl
Total bilirubin: 1.5 mg/dl >
AST (GOT), ALT (GPT): 80 IU/L >
Serum creatinine: 1.5 mg/dL >
Creatinine clearance: > 50 ml/min (with Cockcroft-Gault's formula)
8) No clinically abnormal finding of ECG within 28 days before registration
9) Patients who can eat food and can be orally administered.
10) Informed consent has been acquired.
Key exclusion criteria
1) Patients with past history of severe drug allergy.
2) Patients with active cancers in other organs or multicentric cancers in colorectum.
3) Contraindication of S-1 administration.
4) Patients who suffered from infection with fever higher than 38 degree.
5) Patients with severe complications such as bowel obstruction, ileus, intestinal pneumonitis or pulmonary fibrosis, uncontrolled diabetes, uncontrolled hypertension, heart failure, renal failure, liver dysfunction and others.
6) Patients with past history of intestinal pneumonitis.
7) Patients with pleural or ascites retention which should be treated.
8) Patients with fresh bleeding from intestinal tract.
9) Patients with watery diarrhea.
10) Women who are willing to pregnancy or possible to be pregnant. Patients who do not intend to prevent pregnancy.
11) Patients who are continuing steroid administration orally or intravenously.
12) Patients with HBs positive.
13) Patients whom doctors consider not to be eligible for this study for some other reasons.
Target sample size
15
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Koh Miura |
Organization
Miyagi Cancer Center
Division name
Department of Surgery
Zip code
Address
47-1 Nodayama, Natori, Miyagi 981-1293, Japan
TEL
+81-22-384-3151
kou-miura@miyagi-pho.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Koh Miura |
Organization
Miyagi Cancer Center
Division name
Department of Surgery
Zip code
Address
47-1 Nodayama, Natori, Miyagi 981-1293, Japan
TEL
+81-22-384-3151
Homepage URL
kou-miura@miyagi-pho.jp
Sponsor or person
Institute
Department of Surgery, Miyagi Cancer Center
Institute
Department
Personal name
Funding Source
Organization
None.
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
None.
Other related organizations
Co-sponsor
Name of secondary funder(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
宮城県立がんセンター
Other administrative information
Date of disclosure of the study information
| 2014 | Year | 12 | Month | 01 | 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
Completed
Date of protocol fixation
| 2014 | Year | 08 | Month | 22 | Day |
Date of IRB
Anticipated trial start date
| 2014 | Year | 11 | Month | 01 | Day |
Last follow-up date
| 2018 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
| 2018 | Year | 12 | Month | 31 | Day |
Date trial data considered complete
| 2018 | Year | 12 | Month | 31 | Day |
Date analysis concluded
| 2018 | Year | 12 | Month | 31 | Day |
Other
Other related information
Management information
Registered date
| 2014 | Year | 10 | Month | 26 | Day |
Last modified on
| 2018 | Year | 11 | Month | 21 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000018039
