search
Back to results

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
Peking University
About
Eligibility
Locations
Arms
Outcomes
Full info

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

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

First Posted
June 13, 2012
Last Updated
May 17, 2015
Sponsor
Peking University
Collaborators
Taiho Pharmaceutical Co., Ltd.
search

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

Learn more about this trial

A PhaseⅡ Study: SOX vs SP in Adjuvant Chemotherapy After D2 Surgery

We'll reach out to this number within 24 hrs