XELOX With Capecitabine Maintenance or XELOX in Elderly Metastatic Adenocarcinoma of Stomach

Gastric Cancer Clinical Trial

Official title:

A Randomized Single Center Phase II Study Comparing XELOX With Capecitabine Maintenance or XELOX Treatment in Elderly Metastatic Adenocarcinoma of Stomach

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01798251
• Other study ID #: CGOG20120101009
• Status: Recruiting
• Phase: Phase 2
• First received: December 13, 2012
• Last updated: May 3, 2013
• Start date: December 2012
• Est. completion date: December 2015

Study information

• Verified date: May 2013
• Source: Harbin Medical University
• Contact: Yuxian BAI, PhD
• Phone: 86 451 86298265
• Email: bai_yuxian[@]126.com
• Is FDA regulated: No
• Health authority: China: Ethics Committee
• Study type: Interventional

Clinical Trial Summary

To confirm the efficacy and safety of XELOX with capecitabine maintenance in treatment of elderly advanced gastric cancer (AGC) by comparing it with that of XELOX regimen.

Description:

To investigate whether XELOX with capecitabine maintenance treatment as 1st line treatment in the elderly advanced gastric cancer is as effective and safe as XELOX regimen.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 40
• Est. completion date: December 2015
• Est. primary completion date: December 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 65 Years and older

Eligibility

Inclusion Criteria:

• Ages Eligible for Study: 65 Years or older

• Genders Eligible for Study: Both

• The Eastern Cooperative Oncology Group (ECOG) status = 2

• Histologically confirmed gastric adenocarcinoma(including LAUREN type).

• Measurable disease(according to the Response Evaluation Criteria in Solid Tumors (RECIST) criteria 1.1).

• chemotherapy naive after recurrence or metastasis. Previous neo-adjuvant or adjuvant treatment for gastric cancer, if applicable, more than 6 months.

• Hb > 90g/L, neutrophil count > or = 1.5*10^9/L, platelet > or = 100*10^9/L, alanine transaminase (ALT) and aspartate aminotransferase (AST) < or = 2.5 times upper limit of nominal (ULN), alkaline phosphatase (ALP) < or = 2.5 times ULN, total bilirubin (TBIL) < 1.5 times ULN, serum albumin level > or = 30g/L, serum creatinine < 1 times ULN.

• No serious concomitant diseases which could lead to death within 5 years. At least 5 years from the last Biological/Immunotherapy/Hormone treatment for Malignancy excluding gastric cancer.

• Able to accept oral medication

• Compliance with protocol

Exclusion Criteria:

• Had received cytotoxic chemotherapy, radiotherapy or immunotherapy for this gastric cancer, excluding Corticosteroids.

• Other previous malignancy within 5 year, except curative skin cancer or carcinoma in situ of uterine cervix.

• Uncontrolled epilepsy, central nervous system disorders, or a history of mental disorders.

• clinically significant(i.e. active)cardiac disease e.g. symptomatic coronary artery disease, New York Heart Association (NYHA) II or more serious congestive heart failure or severe requiring medication intervention arrhythmia, or history of myocardial infarction within the last 12 months.

• Upper gastrointestinal obstruction or physiological dysfunction or suffering from malabsorption syndrome, which could affect the absorption of capecitabine.

• Organ transplantation requires immunosuppressive treatment.

• Severe uncontrolled recurrent infections, or Other serious uncontrolled concomitant diseases.

• Moderate or severe renal impairment(creatinine clearance (CCr) = or < 50 ml/min), or serum creatinine > ULN.

• Known enzyme deficiency of dihydropyrimidine dehydrogenase(DPD).

• Allergy to Oxaliplatin or any study medication ingredients.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Adenocarcinoma
• Gastric Cancer
• Stomach Neoplasms

Intervention

Drug:
• Oxaliplatin
Oxaliplatin 100mg/m2 d1 Intravenous infusion every 3 weeks
• Capecitabine
capecitabine 850mg/m2 bid, d1-14, every 3 weeks

Locations

Country	Name	City	State
China	The tumor hospital of Harbin medical university	Harbin	Heilongjiang

Sponsors (1)

Lead Sponsor	Collaborator
Harbin Medical University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	health-related quality of life (HRQOL)		evaluate every 6 weeks from the date of randomization until 28 days after the last chemo dosage	Yes
Other	excision repair cross-complementing 1(ERCC1) expression	quantitative real-time reverse transcriptase polymerase chain reaction (PCR) assays were performed to determine ERCC1 mRNA expression in tumor tissue.	assays messager ribonucleic acid (mRNA) of ERCC1 expression in tumor tissue after randomization and before the first treatment	No
Other	K-ras gene type	Genomic Deoxyribonucleic acid (DNA) is extracted from tumor tissue, direct sequencing technique is used to test K-ras gene type(mutation or wild).	assess after randomization and before the first treatment	No
Primary	Progression Free Survival (PFS)		From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 12 months	No
Secondary	overall survival (OS)		from the date of randomization until death from any cause or up to 1 year	No
Secondary	Response Rate (RR)		evaluate every 6 weeks after the date of randomization until diease progress or up to 12 weeks	No
Secondary	adverse events (AE)		from date of randomization to 28 days after the last chemo dosage	Yes