S-1+Oxaliplatin vs.S-1+Cisplatin First-line Treatment of Advanced or Recurrent Non-intestinal Type Gastric Adenocarcinoma Patients

NCT01824459 | Completed Phase 3

• 1 other identifier: SOX-DGCA
• Study Type: interventional
• Target: 576
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to evaluate the effectiveness and safety of S-1+Oxaliplatin vs.S-1+Cisplatin First-line Treatment in Advanced or Recurrent Non-intestinal Gastric Adenocarcinoma or Gastroesophageal Junction Adenocarcinoma Patients.

Conditions

Gastric Cancer

Keywords

Non-intestinal type gastric cancer; Advance Gastric Cancer; Recurrent Gastric Cancer; Gastroesophageal Junction Adenocarcinoma; SOX, S-1+Oxaliplatin; OS,; ORR,; PFS,; TTF,; safety

Outcome Measures

Primary Outcomes (1)

• Overall Survival

  OS means that from the first dose of treatment drug to death or lost, the follow-up visit will be performed every 12 weeks till death or lost

  1-1.5 year

Secondary Outcomes (4)

• Objective response rate

  1 year

• time to treatment failure (TTF)

  6 months

• progression-free survival (PFS)

  6 months

• Adverse events (AE)

  1-1.5 years

Study Arms (2)

S-1 + cisplatin(SP)

ACTIVE COMPARATOR

S-1：40\~60mg bid，d1\~14 q3W cisplatin：60mg/m2，iv drip ，d1,q3W Number of Cycles: until progression or unacceptable toxicity develops.

Drug: S-1; Drug: Cisplatin

S-1+Oxaliplatin（SOX）

EXPERIMENTAL

S-1：40\~60mg bid，d1\~14 q3W oxaliplatin：130mg/m2，iv drip for 2h，d1,q3W Number of Cycles: until progression or unacceptable toxicity develops.

Drug: S-1; Drug: Oxaliplatin

Interventions

S-1 DRUG

S-1：40\~60mg bid，d1\~14 q3W

S-1 + cisplatin(SP); S-1+Oxaliplatin（SOX）

Oxaliplatin DRUG

oxaliplatin：130mg/m2，iv drip for 2h，d1,q3W

S-1+Oxaliplatin（SOX）

Cisplatin DRUG

cisplatin：60mg/m2，iv drip ，d1,q3W

S-1 + cisplatin(SP)

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• histologically confirmed unresectable advanced or recurrent diffuse-type or mixed-type gastric adenocarcinoma or gastroesophageal junction adenocarcinoma.
• years old to 75 years old, able to conduct oral administration.
• Measurable disease or non-measurable but evaluable disease, according to the Response Evaluation Criteria in Solid Tumours(RECIST 1.1)
• No palliative chemotherapy and radiotherapy. Previous adjuvant or neoadjuvant chemotherapy , if applicable, more than 12 months.
• ECOG systemic status score of 0 to 2.
• normal organ function, that meet the following criteria:
• ALT and AST(≤2.5 times ULN (≤5 times ULN in patients with liver metastases)
• ALP ≤ 2 times ULN ; (for patients with liver metastases can be no limit to the ALP).
• Total bilirubin ≤ 1 times ULN.
• Absolute neutrophil count ≥ 2.0 × 10\^9 / L.
• Platelet count ≥ 100 × 10\^9 / L.
• Hemoglobin ≥ 80g / L.
• Creatinine ≤ 1.25 times ULN.
• The estimated creatinine clearance ≥ 60 mL/min (Cockcroft-Gault formula).
• Signed informed consent, treatment, follow-up and inspection in accordance with the study protocol.

You may not qualify if:

• Previous adjuvant or neoadjuvant chemotherapy within the prescribed time
• the investigator determines that the patient is not suitable for participation in this study, and specifically includes (but is not limited to):
• The past five years there have been other malignancies, but after appropriate treatment of cervical carcinoma in situ and non-melanoma skin cancer.
• brain metastases or leptomeningeal metastasis.
• myocardial infarction (within the past six months), severe unstable angina, congestive heart failure.
• Serious complications (including paralytic ileus, intestinal obstruction, interstitial pneumonia, lung fibrosis, beyond the control of diabetes, renal insufficiency and cirrhosis of the liver, etc.).
• Chronic nausea, vomiting, or diarrhea (per day greater than or equal to 4 times or watery stools).
• Gastrointestinal bleeding, and need for frequent blood transfusions.
• human immunodeficiency virus (HIV) carrier or suffering from AIDS (AIDS).
• Suffering from a mental illness.
• neuropathy severity ≥grade 2 .
• Infectious disease or inflammation, body temperature ≥ 38 ℃.
• Cisplatin, oxaliplatin, or S-1 allergy.
• Pregnancy or breast-feeding women.
• refused to take appropriate contraceptive measures (including male patients).

Sponsors & Collaborators

• Sun Yat-sen University: lead
• Taiho Pharmaceutical Co., Ltd.: collaborator

Study Sites (1)

Sun Yat-sen University Cancer Center

Guangzhou, Guangdong, 510060, China

Location

MeSH Terms

Conditions

Stomach Neoplasms

Interventions

S 1 (combination); Oxaliplatin; Cisplatin

Condition Hierarchy (Ancestors)

Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Stomach Diseases

Intervention Hierarchy (Ancestors)

Coordination Complexes; Organic Chemicals; Chlorine Compounds; Inorganic Chemicals; Nitrogen Compounds; Platinum Compounds

Study Officials

• ruihua xu, Professor

  SunYat-sen University Cancer Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: vice president of SunYat-sen University Cancer Center,head of medical oncology department

Study Record Dates

• First Submitted: April 1, 2013
• First Posted: April 4, 2013
• Study Start: April 1, 2013
• Primary Completion: December 1, 2018
• Study Completion: December 1, 2018
• Last Updated: January 23, 2019

Record last verified: 2019-01

Locations

CN (1)