Efficacy and Safety of S-1 Plus Oxaliplatin in First-line Treatment of Ederly Patients With Advanced Gastric Cancer

NCT ID: NCT04694404

Last Updated: 2021-01-05

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE2
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-05-11
• Study Completion Date: 2022-12-01

Brief Summary

Elderly patients have poor tolerance and physical condition, we will prove 2-week schedule of oxaliplatin plus S-1 have a good efficacy and a better safety for elderly patients with advanced or recurrent gastric cancer.

Detailed Description

3-week plan of S-1 plus Oxaliplatin has been widely used,but it also has cumulative toxicity.Meanwhile elderly patients have poor tolerance and physical condition, we will prove 2-weeks schedule of oxaliplatin plus S-1 have a good efficacy and a better safety for elderly patients with advanced or recurrent gastric cancer.Untreated elderly patients with advanced or recurrent gastric cancer will receive Oxaliplatin 85 mg/m2 (D1, q2w) and S-1(40mg BID for body surface area < 1.25 m2; 50mg BID for body surface area of 1.25-1.5m2; and 60mg BID for body surface area >1.5 m2; D1-10, q2w) as the first-line treatment. We will investigate the efficacy and safety of the combination treatment, and expect to provide a good effective treatment plan and a better safety for elderly patients with advanced or recurrent gastric cancer in China.The primary endpoint is progression-free survival(PFS), and the secondary endpoints are objective response rate(ORR), overall survival(OS) and the safety.

Conditions

S-1 Plus Oxaliplatin

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

S-1 Plus Oxaliplatin

Oxaliplatin 85 mg/m2 (D1, q2w) and S-1 (40mg BID for body surface area \< 1.25 m2; 50mg BID for body surface area of 1.25-1.5 m2; and 60mg BID for body surface area \>1.5 m2; D1-10, q2w)

Group Type: EXPERIMENTAL

S-1,Oxaliplatin

Intervention Type: DRUG

Oxaliplatin 85 mg/m2 (D1, q2w) and S-1 (40mg BID for body surface area \< 1.25 m2; 50mg BID for body surface area of 1.25-1.5 m2; and 60mg BID for body surface area \>1.5 m2; D1-10, q2w)

Interventions

S-1,Oxaliplatin

Oxaliplatin 85 mg/m2 (D1, q2w) and S-1 (40mg BID for body surface area \< 1.25 m2; 50mg BID for body surface area of 1.25-1.5 m2; and 60mg BID for body surface area \>1.5 m2; D1-10, q2w)

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• Histologically confirmed unresectable or recurrent gastric or gastroesophageal junction adenocarcinoma;
• Aged≥60
• ability of oral administration;
• CT or MRI can be used to assess measurable or non-measurable lesions according to the criteria of Response Evaluation Criteria In Solid Tumours (RECIST 1.1);
• Untreated
• more than 12 months after the last adjuvant/neoadjuvant chemotherapy;
• ECOG=0-2;
• Available organ function: ALT≤2.5xULN;AST≤2.5xULN;If patients have hepaticmetastasis,ALT≤2.5xULN,AST≤2.5xULN;ALP≤2xULN;TBIL≤1.0xULN;NEUT≥1.5×109/L;PLT≥100×109/L;Hb≥90g/L;Creatinine≤1.0xULN;Creatinine Clearance≥60ml/min
• Informed consent;
• Expected survival more than 3 months;More than 3 weeks after major surgery.

Exclusion Criteria

• Neoadjuvant and/or adjuvant have been treated with more than two plans;
• In the past two years, the total dose of oxaliplatin≥800mg/m2;
• Other cancers in the past 5 years,except for cervical carcinoma in situ or non-melanoma skin cancer;
• Symptomatic brain metastases or soft meningeal metastasis;
• Myocardial infarction (in the last 6 months), severe instability angina, congestive heart failure;
• Serious complications (including intestinal paralysis, gastrointestinal obstruction, interstitial pneumonia, pulmonary fibrosis, uncontrolled diabetes, renal insufficiency and cirrhosis); Chronic nausea, vomiting or diarrhea (more than 4 times per day, or watery);Gastrointestinal bleeding requires regular blood transfusion;HIV or AIDS; Mental illness; Neuropathy grade≥2;Infectious diseases or inflammation, temperature≥38℃;
• Known allergy to drugs in the study;
• Pregnant or lactating women;
• Both male and female subjects of potential fertility have to agree effective birth control during the entire study;
• Experimental drugs used no more than 4 weeks;
• Other conditions the researchers considered ineligible for the study.

• Minimum Eligible Age: 60 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Aiping Zhou

UNKNOWN

Sponsor Role: lead

Responsible Party

Aiping Zhou

Chief physician

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Aiping Zhou, Doctor

Role: STUDY_DIRECTOR

Chinese Academy of Medical Sciences

Locations

National Cancer Center/Cancer Hospital, Chinese ACademy of Medical Sciences and Peking Union Medical College

Beijing, , China

Site Status: RECRUITING

Countries

China

Central Contacts

Aiping Zhou, Doctor

Role: CONTACT

zhouap1825@126.com

+86 13691161998

Facility Contacts

Aiping Zhou, Doctor

Role: primary

zhouap1825@126.com

+86 13691161998

References

Jiang Z, Zhou A, Sun Y, Zhang W. Biweekly oxaliplatin plus S1 for Chinese elderly patients with advanced gastric or gastroesophageal junction cancer as the first-line therapy: a single-arm, phase 2 study. BMC Cancer. 2022 Mar 9;22(1):253. doi: 10.1186/s12885-022-09332-7.

Reference Type: DERIVED

PMID: 35264150 (View on PubMed)

Other Identifiers

CH-PI-105

Identifier Type: -

Identifier Source: org_study_id