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

NCT04694404 | Unknown Phase 2

• 1 other identifier: CH-PI-105
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

S-1 Plus Oxaliplatin

Keywords

S-1,Oxaliplatin,Advanced or Recurrent Gastric Cancer

Outcome Measures

Primary Outcomes (1)

• PFS

  Progression-free survival

  6 months

Secondary Outcomes (3)

• ORR

  6 months

• OS

  1 year

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

  1 year

Study Arms (1)

S-1 Plus Oxaliplatin

EXPERIMENTAL

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)

Drug: S-1,Oxaliplatin

Interventions

S-1,Oxaliplatin 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)

S-1 Plus Oxaliplatin

Eligibility Criteria

• Age: 60 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Aiping Zhou: lead

Study Sites (1)

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

Beijing, 100021, China

RECRUITING

Related Publications (1)

• 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.

  PMID: 35264150 DERIVED

MeSH Terms

Conditions

Stomach Neoplasms

Condition Hierarchy (Ancestors)

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

Study Officials

• Aiping Zhou, Doctor

  Chinese Academy of Medical Sciences

  STUDY DIRECTOR

Central Study Contacts

Aiping Zhou, Doctor

CONTACT

+86 13691161998; zhouap1825@126.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: UNKNOWN
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Chief physician

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

Study Record Dates

• First Submitted: November 5, 2017
• First Posted: January 5, 2021
• Study Start: May 11, 2016
• Primary Completion: December 1, 2021
• Study Completion: December 1, 2022
• Last Updated: January 5, 2021

Record last verified: 2021-01

Locations

CN (1)