Clinical trial NCT01679340: 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
Overall status: UNKNOWN
Phase: PHASE2
Conditions: Gastric Cancer
Keywords: Gastric cancer
D2 surgery
S-1
Oxaliplatin
cisplatin
Lead sponsor: Peking University
Sponsor class: OTHER
Collaborators: name: Taiho Pharmaceutical Co., Ltd.
First posted: 2012-09-06
Enrollment: 160
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.


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.

Primary outcomes:
measure: replase free survival
timeFrame: 3 months
Secondary outcomes:
measure: overall survival
timeFrame: 6 months
measure: Number of Participants with Adverse Events as a Measure of Safety and Tolerability
timeFrame: 3 months
Other outcomes:
Locations:
city: Beijing
country: China
facility: Beijing Cancer Hospital
state: Beijing
Study officials:
References: