A PhaseⅡ Study: SOX vs SP in Adjuvant Chemotherapy After D2 Surgery
This study is currently recruiting participants.
Verified September 2012 by Peking University
Sponsor:
Peking University
Collaborator:
Taiho Pharmaceutical Co., Ltd.
Information provided by (Responsible Party):
Shen Lin, Peking University
ClinicalTrials.gov Identifier:
NCT01679340
First received: June 13, 2012
Last updated: September 2, 2012
Last verified: September 2012
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Gastric Cancer |
Drug: S-1 Drug: oxaliplatin Drug: cisplatin |
Phase 2 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Prevention |
| 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 |
Resource links provided by NLM:
Further study details as provided by Peking University:
Primary Outcome Measures:
- replase free survival [ Time Frame: 3 months ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- overall survival [ Time Frame: 6 months ] [ Designated as safety issue: No ]
- Number of Participants with Adverse Events as a Measure of Safety and Tolerability [ Time Frame: 3 months ] [ Designated as safety issue: Yes ]
| Estimated Enrollment: | 160 |
| Study Start Date: | April 2011 |
| Estimated Study Completion Date: | June 2018 |
| Estimated Primary Completion Date: | March 2018 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: S-1+oxaliplatin
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.
|
Drug: S-1
Mode of administration: orally (capsules) Dosing schedule:80mg/m2, Bid,D1-14,every 3 week,for 8-10cycles
Other Names:
Drug: oxaliplatin
Mode of administration: intravenously Doseing schedule: 65 mg/m2 D1,D8,every 3 week, for 6 cycles
|
|
Active Comparator: S-1+cisplatin
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.
|
Drug: S-1
Mode of administration: orally (capsules) Dosing schedule:80mg/m2, Bid,D1-14,every 3 week,for 8-10cycles
Other Names:
Drug: cisplatin
Mode of administration: intravenously Dosing schedule: 75mg/m2 D1,every 3 week,for 6 cycle
|
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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.
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01679340
Contacts
| Contact: Shen Lin, professor | 010-88196561 | xiaotong10241@sina.com |
Locations
| China, Bejing | |
| Beijing Cancer Hospital | Recruiting |
| Beijing, Bejing, China, 100142 | |
| Contact: Shen Lin, Professor 010-88196561 xiaotong10241@sina.com | |
| Principal Investigator: Shen Lin, professor | |
Sponsors and Collaborators
Peking University
Taiho Pharmaceutical Co., Ltd.
More Information
No publications provided
| Responsible Party: | Shen Lin, Director of GI oncology, Peking University |
| ClinicalTrials.gov Identifier: | NCT01679340 History of Changes |
| Other Study ID Numbers: | SOXSP |
| Study First Received: | June 13, 2012 |
| Last Updated: | September 2, 2012 |
| Health Authority: | China: Food and Drug Administration |
Keywords provided by Peking University:
|
Gastric cancer D2 surgery S-1 Oxaliplatin cisplatin |
Additional relevant MeSH terms:
|
Stomach Neoplasms Gastrointestinal Neoplasms Digestive System Neoplasms Neoplasms by Site Neoplasms Digestive System Diseases Gastrointestinal Diseases Stomach Diseases |
Oxaliplatin Cisplatin Antineoplastic Agents Therapeutic Uses Pharmacologic Actions Radiation-Sensitizing Agents Physiological Effects of Drugs |
ClinicalTrials.gov processed this record on June 17, 2013