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

S-1 Plus Oxaliplatin Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04694404
• Other study ID #: CH-PI-105
• Status: Recruiting
• Phase: Phase 2
• Start date: May 11, 2016
• Est. completion date: December 1, 2022

Study information

• Verified date: January 2021
• Source: Chinese Academy of Medical Sciences
• Contact: Aiping Zhou, Doctor
• Phone: +86 13691161998
• Email: zhouap1825[@]126.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 60
• Est. completion date: December 1, 2022
• Est. primary completion date: December 1, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 60 Years and older

Eligibility

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=10 0×109/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.

Related Conditions & MeSH terms

• S-1 Plus Oxaliplatin
• Stomach Neoplasms

Intervention

Drug:
• 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)

Locations

Country	Name	City	State
China	National Cancer Center/Cancer Hospital, Chinese ACademy of Medical Sciences and Peking Union Medical College	Beijing

Sponsors (1)

Lead Sponsor	Collaborator
Aiping Zhou

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	PFS	Progression-free survival	6 months
Secondary	ORR	Objective response rate	6 months
Secondary	OS	Overall survival	1 year
Secondary	The number of participants with treatment-related adverse events as assessed by CTCAE v4.0	Safety	1 year