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UMIN ID:

Recruitment status Main results already published
Unique ID issued by UMIN UMIN000010337
Receipt No. 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

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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
Email 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
Email gc07.dc@jaccro.or.jp

Sponsor
Institute Japan Clinical Cancer Reseach Organization (JACCRO)
Institute
Department

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
Email

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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000012099

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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