UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000010337 |
|---|---|
| Receipt number | R000012099 |
| Scientific Title | A Phase III Study of Docetaxel plus S-1 versus S-1 Alone in the Treatment of Curatively Resected Stage III Gastric Cancer |
| Date of disclosure of the study information | 2013/04/01 |
| Last modified on | 2019/03/08 09:56:37 |
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Basic information
Public title
A Phase III Study of Docetaxel plus S-1 versus S-1 Alone in the Treatment of Curatively Resected Stage III Gastric Cancer
Acronym
JACCRO GC-07 (START-2)
Scientific Title
A Phase III Study of Docetaxel plus S-1 versus S-1 Alone in the Treatment of Curatively Resected Stage III Gastric Cancer
Scientific Title:Acronym
JACCRO GC-07 (START-2)
Region
| Japan |
Condition
Condition
Gastric Cancer
Classification by specialty
| Gastroenterology | Hematology and clinical oncology | Gastrointestinal surgery |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To compare the 3-years recurrence free survival, 5-year overall survival, 5-year recurrence free survival and safety of the test arm (docetaxel and S-1) to the control arm (S-1 only) in patients with curatively resected stage III gastric cancer.
Basic objectives2
Safety
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
3-years recurrence free survival rate
Key secondary outcomes
3-years and 5-years overall survival
5-years recurrence free survival
time to treatment failure
adverse events
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
Active
Stratification
YES
Dynamic allocation
YES
Institution consideration
Institution is considered as adjustment factor in dynamic allocation.
Blocking
NO
Concealment
Central registration
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
1st Course (S-1 alone): S-1 80mg/m2 d1-14, q3w
2nd to 7th Course (S-1 plus docetaxel):Docetaxel: 40 mg/m2 (1 hour IV infusion) on Day 1 of each cycle
S-1: S-1 dosage is dependent upon BSA calculation on Days 1-14 of each cycle. No treatment on Days 15 through 21 of each cycle.Cycles repeated every 3weeks.
After 7th Course, S-1 alone continued until 1 year.
Interventions/Control_2
S-1: S-1 dosage is dependent upon BSA calculation on Days 1 through 28 of each cycle,no treatment on Days 29 through 42 of each cycle, cycles repeated until 1 year.
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. Histologically proven gastric cancer of IIIA, IIIB or IIIC (Histologically Common Type)
2. D2 lymph-node dissection with R0 surgery (with the result of no residual tumor)
3. No hepatic, peritoneal, or distant metastasis; no tumor cells in peritoneal fluid on cytologic analysis
4. Age 20 to 80 years.
5. No previous treatment for cancer except for the initial gastric resection for the primary lesion.
6. ECOG performance status 0 or 1.
7. Within 42 days after gastric resection and adequate self-supported nutritional intake.
8. Hgb>9.0 g/dL, WBC 4000-12,000/mm3, ANC> 1500/mm3, platelets> 100,000/mm3
9. Creatinine< 1.2 mg/dL, Creatinine clearance> 50mL/min
10. Total bilirubin< 1.5 X UNL
11. AST (SGOT) and ALT (SGPT)< 100 IU/L
12. Subjects must have fully recovered from surgical damage
13. Written informed consent
Key exclusion criteria
1. Active double cancer (except focal cancer in adenoma of colorectal cancer and carcinoma in situ of cervical cancer) and/or past history of other cancer.
2. Patients with severe postoperative complication (severe postoperative infections, anastomotic leakage, gastrointestinal bleeding).
3. Patients with severe complication (intestinal paralysis, intestinal obstruction, interstitial pneumonitis, pulmonary fibrosis, severe diabetes, uncontrolled hypertension, heart failure, renal failure, liver cirrhosis, liver failure, etc.).
4. Patient with active infectious desease.
5. Patient with positive HBs antigen or positive HCV antibody.
6. Definite contraindications for the use of corticosteroids.
7. History of hypersensitivity to fluoropyrimidines, docetaxel, or medications formulated with polysorbate 80, other severe drug induced allergy or .
8. History of allergy of both iodine and gadolinium.
9. Patient is taking flucytosine.
10. Pregnancy or lactation women, women with suspected pregnancy or men with willing to get pregnant.
11. Patient with psychosis or psychotic symptoms and judged to be difficult to determine participating clinical trial.
12. Any subject judged by the investigator to be unfit for any reason to participate in the study.
Target sample size
1100
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Yasuhiro Kodera |
Organization
Nagoya University
Division name
Department of Digestive Surgery
Zip code
Address
65, Tsurumai, Showa-ku, Nagoya, Japan
TEL
052-741-2111
ykodera@med.nagoya-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Masashi Fujii |
Organization
Japan Clinical Cancer Reseach Organization (JACCRO)
Division name
Office
Zip code
Address
7F, 1-14-5, Ginza, Chuoh-ku, Tokyo
TEL
03-5579-9882
Homepage URL
gc07.dc@jaccro.or.jp
Sponsor or person
Institute
Japan Clinical Cancer Reseach Organization (JACCRO)
Institute
Department
Personal name
Funding Source
Organization
Japan Clinical Cancer Reseach Organization (JACCRO)
Organization
Division
Category of Funding Organization
Non profit foundation
Nationality of Funding Organization
Japan
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
名古屋大学医学部附属病院（愛知県）ほか、JACCRO参加施設
Other administrative information
Date of disclosure of the study information
| 2013 | Year | 04 | Month | 01 | Day |
Related information
URL releasing protocol
Publication of results
Partially published
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
Main results already published
Date of protocol fixation
| 2013 | Year | 03 | Month | 30 | Day |
Date of IRB
Anticipated trial start date
| 2013 | Year | 04 | Month | 01 | Day |
Last follow-up date
| 2022 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
| 2023 | Year | 02 | Month | 28 | Day |
Date trial data considered complete
| 2023 | Year | 03 | Month | 31 | Day |
Date analysis concluded
| 2023 | Year | 06 | Month | 30 | Day |
Other
Other related information
Management information
Registered date
| 2013 | Year | 03 | Month | 28 | Day |
Last modified on
| 2019 | Year | 03 | Month | 08 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000012099
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| Registered date | File name |
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