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A Study of Capecitabine (Xeloda) in Participants With Advanced or Metastatic Gastric Cancer

Primary Purpose

Gastric Cancer

Status

Completed

Phase

Phase 3

Locations

International

Study Type

Interventional

Intervention

5-Fluorouracil

Capecitabine

Cisplatin

About this trial

This is an interventional treatment trial for Gastric Cancer

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

Adults 18 to 75 years of age
Advanced and/or metastatic gastric cancer with at least 1 measurable lesion

Exclusion Criteria:

Uncontrolled infection
Evidence of central nervous system (CNS) metastases
History of other malignancy within the last 5 years, except cured basal cell cancer of the skin or cured in-situ cancer of the uterine cervix
Radiation therapy or major surgery within 4 weeks of study drug
Previous chemotherapy

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

5-Fluorouracil + Cisplatin

Capecitabine + Cisplatin

Arm Description

Participants will receive 5-FU in combination with cisplatin upto disease progression.

Participants will receive capecitabine in combination with cisplatin upto disease progression.

Outcomes

Primary Outcome Measures

Time to disease progression

Secondary Outcome Measures

Objective tumor response rate

Overall survival

Duration of response

Time to response

Incidence of adverse events

Full Information

NCT ID

NCT02563054

First Posted

September 28, 2015

Last Updated

November 1, 2016

Sponsor

Hoffmann-La Roche

1. Study Identification

Unique Protocol Identification Number

NCT02563054

Brief Title

A Study of Capecitabine (Xeloda) in Participants With Advanced or Metastatic Gastric Cancer

Official Title

An Open-Label Randomized International Multi-Center Phase III Study of Capecitabine (Xeloda) in Combination With Cisplatin Versus FU/Cisplatin in Patients With Advanced and/or Metastatic Gastric Cancer

Study Type

Interventional

2. Study Status

Record Verification Date

November 2016

Overall Recruitment Status

Completed

Study Start Date

April 2003 (undefined)

Primary Completion Date

August 2010 (Actual)

Study Completion Date

August 2010 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Hoffmann-La Roche

4. Oversight

5. Study Description

Brief Summary

This study will evaluate the efficacy and safety of oral capecitabine (Xeloda) versus 5-fluorouracil (5-FU), in combination with intravenous (IV) cisplatin, in participants with advanced and/or metastatic gastric cancer. The anticipated time on study treatment is at least 6 weeks and continued up to disease progression, and the target sample size is 300 individuals.

6. Conditions and Keywords

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

Gastric Cancer

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 3

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

316 (Actual)

8. Arms, Groups, and Interventions

Arm Title

5-Fluorouracil + Cisplatin

Arm Type

Active Comparator

Arm Description

Participants will receive 5-FU in combination with cisplatin upto disease progression.

Arm Title

Capecitabine + Cisplatin

Arm Type

Experimental

Arm Description

Participants will receive capecitabine in combination with cisplatin upto disease progression.

Intervention Type

Drug

Intervention Name(s)

5-Fluorouracil

Intervention Description

Participants will receive 5-FU, 800 milligrams per meter-squared (mg/m^2) per day via IV infusion during Days 1 to 5 of each 3-week cycle, for a total of 6 cycles in combination with cisplatin or upto disease progression.

Intervention Type

Drug

Intervention Name(s)

Capecitabine

Intervention Description

Participants will receive oral capecitabine, 1000 mg/m^2 twice daily on Days 1 to 14 of each 3-week cycle, for a total of 6 cycles in combination with cisplatin or upto disease progression.

Intervention Type

Drug

Intervention Name(s)

Cisplatin

Intervention Description

Participants will receive cisplastin, 80 mg/m^2 via IV infusion on Day 1 of each 3-week cycle, for a total of 6 cycles or upto disease progression in combination with either capecitabine or 5-FU.

Primary Outcome Measure Information:

Title

Time to disease progression

Time Frame

Up to approximately 7.3 years

Secondary Outcome Measure Information:

Title

Objective tumor response rate

Time Frame

Up to approximately 7.3 years

Title

Overall survival

Time Frame

Up to approximately 7.3 years

Title

Duration of response

Time Frame

Up to approximately 7.3 years

Title

Time to response

Time Frame

Up to approximately 7.3 years

Title

Incidence of adverse events

Time Frame

Up to approximately 7.3 years

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

75 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Adults 18 to 75 years of age Advanced and/or metastatic gastric cancer with at least 1 measurable lesion Exclusion Criteria: Uncontrolled infection Evidence of central nervous system (CNS) metastases History of other malignancy within the last 5 years, except cured basal cell cancer of the skin or cured in-situ cancer of the uterine cervix Radiation therapy or major surgery within 4 weeks of study drug Previous chemotherapy

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Clinical Trials

Organizational Affiliation

Hoffmann-La Roche

Official's Role

Study Chair

Facility Information:

City

Buenos Aires

ZIP/Postal Code

C1264AAA

Country

Argentina

City

Buenos Aires

ZIP/Postal Code

C1270AAE

Country

Argentina

City

Rosario

ZIP/Postal Code

S2000PBJ

Country

Argentina

City

Tegucigalpa

Country

Belize

City

Barretos

ZIP/Postal Code

14780-400

Country

Brazil

City

Curitiba

ZIP/Postal Code

80060-150

Country

Brazil

City

Florianopolis

ZIP/Postal Code

88034-000

Country

Brazil

City

Fortaleza

ZIP/Postal Code

60741-420

Country

Brazil

City

Porto Alegre

ZIP/Postal Code

90020-090

Country

Brazil

City

Sao Paulo

ZIP/Postal Code

05403-010

Country

Brazil

City

Sorocaba

ZIP/Postal Code

18035-300

Country

Brazil

City

Beijing

ZIP/Postal Code

100021

Country

China

City

Beijing

ZIP/Postal Code

100036

Country

China

City

Guangdong

ZIP/Postal Code

510060

Country

China

City

Guangdong

ZIP/Postal Code

510515

Country

China

City

Hubei

ZIP/Postal Code

430030

Country

China

City

Jiangsu

ZIP/Postal Code

210009

Country

China

City

Jiangxi

ZIP/Postal Code

330000

Country

China

City

Shandong

ZIP/Postal Code

250117

Country

China

City

Shanghai

ZIP/Postal Code

200003

Country

China

City

Shanghai

ZIP/Postal Code

200092

Country

China

City

Shanghai

ZIP/Postal Code

200433

Country

China

City

Suzhou

ZIP/Postal Code

215006

Country

China

City

Tianjin

ZIP/Postal Code

300060

Country

China

City

Bogota

Country

Colombia

City

Guatemala City

ZIP/Postal Code

01015

Country

Guatemala

City

Hong Kong

ZIP/Postal Code

852

Country

Hong Kong

City

Hong Kong

Country

Hong Kong

City

Seoul

ZIP/Postal Code

135-170

Country

Korea, Republic of

City

Seoul

ZIP/Postal Code

135-720

Country

Korea, Republic of

City

Seoul

ZIP/Postal Code

138-736

Country

Korea, Republic of

City

Seoul

ZIP/Postal Code

405-760

Country

Korea, Republic of

City

Kuala Lumpur

ZIP/Postal Code

56000

Country

Malaysia

City

Merida

ZIP/Postal Code

97070

Country

Mexico

City

Mexico City

ZIP/Postal Code

14000

Country

Mexico

City

Mexico City

ZIP/Postal Code

14080

Country

Mexico

City

Mexico Df

ZIP/Postal Code

06726

Country

Mexico

City

Panama City

ZIP/Postal Code

83-0669

Country

Panama

City

Callao

Country

Peru

City

Lima

ZIP/Postal Code

Country

Peru

City

Kazan

ZIP/Postal Code

420029

Country

Russian Federation

City

Moscow

ZIP/Postal Code

115478

Country

Russian Federation

City

St Petersburg

ZIP/Postal Code

197758

Country

Russian Federation

City

UFA

ZIP/Postal Code

450054

Country

Russian Federation

City

Montevideo

ZIP/Postal Code

11600

Country

Uruguay

12. IPD Sharing Statement

Citations:

PubMed Identifier

29372626

Citation

Chen J, Xiong J, Wang J, Zheng L, Gao Y, Guan Z. Capecitabine/cisplatin versus 5-fluorouracil/cisplatin in Chinese patients with advanced and metastatic gastric cancer: Re-analysis of efficacy and safety data from the ML17032 phase III clinical trial. Asia Pac J Clin Oncol. 2018 Oct;14(5):e310-e316. doi: 10.1111/ajco.12832. Epub 2018 Jan 26.

Results Reference

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A Study of Capecitabine (Xeloda) in Participants With Advanced or Metastatic Gastric Cancer

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