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

Primary Purpose

S-1 Plus Oxaliplatin

Status

Unknown status

Phase

Phase 2

Locations

China

Study Type

Interventional

Intervention

S-1,Oxaliplatin

About this trial

This is an interventional treatment trial for S-1 Plus Oxaliplatin focused on measuring S-1,Oxaliplatin,Advanced or Recurrent Gastric Cancer

Eligibility Criteria

60 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

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

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

S-1 Plus Oxaliplatin

Arm Description

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)

Outcomes

Primary Outcome Measures

PFS

Progression-free survival

Secondary Outcome Measures

ORR

Objective response rate

Overall survival

The number of participants with treatment-related adverse events as assessed by CTCAE v4.0

Safety

Full Information

NCT ID

NCT04694404

First Posted

November 5, 2017

Last Updated

January 4, 2021

Sponsor

Aiping Zhou

1. Study Identification

Unique Protocol Identification Number

NCT04694404

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

January 2021

Overall Recruitment Status

Unknown status

Study Start Date

May 11, 2016 (Actual)

Primary Completion Date

December 1, 2021 (Anticipated)

Study Completion Date

December 1, 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor-Investigator

Name of the Sponsor

Aiping Zhou

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

S-1 Plus Oxaliplatin

Keywords

S-1,Oxaliplatin,Advanced or Recurrent Gastric Cancer

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Single Group Assignment

Model Description

Single Group Assignment Eledrly Patients with Untreated Advanced or Recurrent Gastric Cancer

Masking

None (Open Label)

Allocation

N/A

Enrollment

60 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

S-1 Plus Oxaliplatin

Arm Type

Experimental

Arm Description

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

Intervention Name(s)

S-1,Oxaliplatin

Intervention Description

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)

Primary Outcome Measure Information:

Title

PFS

Description

Progression-free survival

Time Frame

6 months

Secondary Outcome Measure Information:

Title

ORR

Description

Objective response rate

Time Frame

6 months

Title

Description

Overall survival

Time Frame

1 year

Title

The number of participants with treatment-related adverse events as assessed by CTCAE v4.0

Description

Safety

Time Frame

1 year

10. Eligibility

Sex

All

Minimum Age & Unit of Time

60 Years

Accepts Healthy Volunteers

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.

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Aiping Zhou, Doctor

Phone

+86 13691161998

zhouap1825@126.com

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Aiping Zhou, Doctor

Organizational Affiliation

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

Official's Role

Study Director

Facility Information:

Facility Name

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

City

Beijing

ZIP/Postal Code

100021

Country

China

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Aiping Zhou, Doctor

Phone

+86 13691161998

zhouap1825@126.com

First Name & Middle Initial & Last Name & Degree

Aiping Zhou, Doctor

12. IPD Sharing Statement

Citations:

PubMed Identifier

35264150

Citation

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.

Results Reference

derived

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

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