A PhaseⅡ Study: SOX vs SP in Adjuvant Chemotherapy After D2 Surgery
Primary Purpose
Gastric Cancer
Status
Unknown status
Phase
Phase 2
Locations
China
Study Type
Interventional
Intervention
S-1
oxaliplatin
cisplatin
Sponsored by
About this trial
This is an interventional prevention trial for Gastric Cancer focused on measuring Gastric cancer, D2 surgery, S-1, Oxaliplatin, cisplatin
Eligibility Criteria
Inclusion Criteria:
- histologically confirmed Phase III adenocarcinoma of gastric and esophageal-gastric junction ( AJCC 7th)
- without previous treatment, including radiotherapy, chemotherapy and immunotherapy
- Hb≥90g/L,WBC 4×109/L-10×109/L,ANC≥2×109/L,Platelet≥100×109/L
- creatinine≤1 UNL
- total bilirubin≤1.5 UNL,AST(SGOT),ALT(SGPT) and ALP≤2.5 UNL
- ECOG score 0 - 2
- take chemotherapy for 8 weeks after surgery
- older than 18 years
- can be followed up, good compliance
- can take medicine orally
- having signed informed consent
Exclusion Criteria:
- combined disease lead to Life Expectancy less than 3 years
- any evidence to show metastasis,including cancer cells in peritoneal fluid
- inability to take oral medication for difficult to swallow, intestinal obstruction,active intestinal blooding or perforation
- previous treatment,including cytotoxic chemotherapy, radio chemotherapy or immunotherapy ( except corticosteroid hormone)
- operation within 4 weeks, or not recovered from last major operation
- allergy with fluorouracil
- allergy with Platinum or any composition in research drugs
- uncontrollable seizure disorder,central nervous system disease or mental disorders, and has clinical significance by judgement of researchers, or can influnce understanding of informed consent or compliance to take orally drugs
- in the past 12 months, has clinical significant heart disease(active),such as symptomatic coronary heart disease, > =Stage II congestive cardiac failure;congestive heart failure as NYHA standard, or serious arrhythmias need take medicine( as Appendix 10th),or myocardical infarction.
- pregnancy, lactation, women in child-bearing period and her spouses reject to take effictive method to conraception
- other previous malignancy within 5 years, except healed skin basal cell carcinoma and carcinoma in cervix
- peripheral neuropathy> grade 1 of CTCAEv3, except the neural abnormality patients who only lose deep tendon reflex(DTRs).
- serious complicated infection or other complicated diseases and hard to controll.
- As one of belowing:
- ANC < 2×109/L
- Platelet<100×109/L
- total bilirubin>1.5 UNL
- ALAT、ASAT > 2.5 x ULN
- ALP> 2.5 x ULN
- Any investigational agent within the past 28 days. That is the patient had jioned another trial.
Sites / Locations
- Beijing Cancer HospitalRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
S-1+oxaliplatin
S-1+cisplatin
Arm Description
S-1: 80mg/m2, 3weeks/cycle(take for 14d, rest for 7d oxaliplatin: 65mg/m2, D1,D8, 3weeks/cycle after 6 cycles, then mono S-1 for 2-4 cycles, total 8-10 cycles.
S-1: 80mg/m2, 3weeks/cycle(take for 14d, rest for 7d) cisplatin: 75mg/m2, D1, every 3 weeks After 6 cycles, then mono S-1 for 2-4 cycles, total 8-10 cycles.
Outcomes
Primary Outcome Measures
replase free survival
Secondary Outcome Measures
overall survival
Number of Participants with Adverse Events as a Measure of Safety and Tolerability
Full Information
NCT ID
NCT01679340
First Posted
June 13, 2012
Last Updated
May 17, 2015
Sponsor
Peking University
Collaborators
Taiho Pharmaceutical Co., Ltd.
1. Study Identification
Unique Protocol Identification Number
NCT01679340
Brief Title
A PhaseⅡ Study: SOX vs SP in Adjuvant Chemotherapy After D2 Surgery
Official Title
Phase Ⅱ Study of S-1 Combined With Oxaliplatin (SOX)Verse S-1 Combined With Cisplatin(SP) in Adjuvant Chemotherapy After D2 Surgery
Study Type
Interventional
2. Study Status
Record Verification Date
May 2015
Overall Recruitment Status
Unknown status
Study Start Date
April 2011 (undefined)
Primary Completion Date
March 2018 (Anticipated)
Study Completion Date
June 2018 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Peking University
Collaborators
Taiho Pharmaceutical Co., Ltd.
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
To investigate the efficiency and safety of SOX or SP adjuvant chemotherapy to phase II and III gastric cancer patients after D2 surgery. If SOX is equal to SP in efficiency and less toxicity.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Gastric Cancer
Keywords
Gastric cancer, D2 surgery, S-1, Oxaliplatin, cisplatin
7. Study Design
Primary Purpose
Prevention
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
160 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
S-1+oxaliplatin
Arm Type
Experimental
Arm Description
S-1: 80mg/m2, 3weeks/cycle(take for 14d, rest for 7d oxaliplatin: 65mg/m2, D1,D8, 3weeks/cycle after 6 cycles, then mono S-1 for 2-4 cycles, total 8-10 cycles.
Arm Title
S-1+cisplatin
Arm Type
Active Comparator
Arm Description
S-1: 80mg/m2, 3weeks/cycle(take for 14d, rest for 7d) cisplatin: 75mg/m2, D1, every 3 weeks After 6 cycles, then mono S-1 for 2-4 cycles, total 8-10 cycles.
Intervention Type
Drug
Intervention Name(s)
S-1
Other Intervention Name(s)
TS-1, Aisiwan
Intervention Description
Mode of administration: orally (capsules) Dosing schedule:80mg/m2, Bid,D1-14,every 3 week,for 8-10cycles
Intervention Type
Drug
Intervention Name(s)
oxaliplatin
Intervention Description
Mode of administration: intravenously Doseing schedule: 65 mg/m2 D1,D8,every 3 week, for 6 cycles
Intervention Type
Drug
Intervention Name(s)
cisplatin
Intervention Description
Mode of administration: intravenously Dosing schedule: 75mg/m2 D1,every 3 week,for 6 cycle
Primary Outcome Measure Information:
Title
replase free survival
Time Frame
3 months
Secondary Outcome Measure Information:
Title
overall survival
Time Frame
6 months
Title
Number of Participants with Adverse Events as a Measure of Safety and Tolerability
Time Frame
3 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
histologically confirmed Phase III adenocarcinoma of gastric and esophageal-gastric junction ( AJCC 7th)
without previous treatment, including radiotherapy, chemotherapy and immunotherapy
Hb≥90g/L,WBC 4×109/L-10×109/L,ANC≥2×109/L,Platelet≥100×109/L
creatinine≤1 UNL
total bilirubin≤1.5 UNL,AST(SGOT),ALT(SGPT) and ALP≤2.5 UNL
ECOG score 0 - 2
take chemotherapy for 8 weeks after surgery
older than 18 years
can be followed up, good compliance
can take medicine orally
having signed informed consent
Exclusion Criteria:
combined disease lead to Life Expectancy less than 3 years
any evidence to show metastasis,including cancer cells in peritoneal fluid
inability to take oral medication for difficult to swallow, intestinal obstruction,active intestinal blooding or perforation
previous treatment,including cytotoxic chemotherapy, radio chemotherapy or immunotherapy ( except corticosteroid hormone)
operation within 4 weeks, or not recovered from last major operation
allergy with fluorouracil
allergy with Platinum or any composition in research drugs
uncontrollable seizure disorder,central nervous system disease or mental disorders, and has clinical significance by judgement of researchers, or can influnce understanding of informed consent or compliance to take orally drugs
in the past 12 months, has clinical significant heart disease(active),such as symptomatic coronary heart disease, > =Stage II congestive cardiac failure;congestive heart failure as NYHA standard, or serious arrhythmias need take medicine( as Appendix 10th),or myocardical infarction.
pregnancy, lactation, women in child-bearing period and her spouses reject to take effictive method to conraception
other previous malignancy within 5 years, except healed skin basal cell carcinoma and carcinoma in cervix
peripheral neuropathy> grade 1 of CTCAEv3, except the neural abnormality patients who only lose deep tendon reflex(DTRs).
serious complicated infection or other complicated diseases and hard to controll.
As one of belowing:
ANC < 2×109/L
Platelet<100×109/L
total bilirubin>1.5 UNL
ALAT、ASAT > 2.5 x ULN
ALP> 2.5 x ULN
Any investigational agent within the past 28 days. That is the patient had jioned another trial.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Shen Lin, professor
Phone
010-88196561
Email
xiaotong10241@sina.com
Facility Information:
Facility Name
Beijing Cancer Hospital
City
Beijing
State/Province
Beijing
ZIP/Postal Code
100142
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Shen Lin, Professor
Phone
010-88196561
Email
xiaotong10241@sina.com
First Name & Middle Initial & Last Name & Degree
Shen Lin, professor
12. IPD Sharing Statement
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A PhaseⅡ Study: SOX vs SP in Adjuvant Chemotherapy After D2 Surgery
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