Gastric CancerPhase 3NCT02563054
A Study of Capecitabine (Xeloda) in Participants With Advanced or Metastatic Gastric Cancer
A Phase 3 study testing 5-Fluorouracil, Capecitabine and Cisplatin in people with Gastric Cancer, run by Hoffmann-La Roche at 45 sites in 14 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Gastric Cancer
- What is being tested?
- 5-Fluorouracil, Capecitabine and Cisplatin
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 316 participants
- Where
- 45 sitesin 14 countries
- Study dates
- Apr 2003to Aug 2010
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adults 18 to 75 years of age
- Advanced and/or metastatic gastric cancer with at least 1 measurable lesion
Who cannot join
- 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
Trial locations and contacts
45 sites in 14 countries.
45 sites in 14 countries
China13 sites
Study site
Beijing, 100021
Study site
Beijing, 100036
Study site
Guangdong, 510060
Study site
Guangdong, 510515
Study site
Hubei, 430030
Study site
Jiangsu, 210009
Study site
Jiangxi, 330000
Study site
Shandong, 250117
Study site
Shanghai, 200003
Study site
Shanghai, 200092
Study site
Shanghai, 200433
Study site
Suzhou, 215006
Study site
Tianjin, 300060
Brazil7 sites
Study site
Barretos, 14780-400
Study site
Curitiba, 80060-150
Study site
Florianópolis, 88034-000
Study site
Fortaleza, 60741-420
Study site
Porto Alegre, 90020-090
Study site
São Paulo, 05403-010
Study site
Sorocaba, 18035-300
Mexico4 sites
Study site
Mérida, 97070
Study site
Mexico City, 06726
Study site
Mexico City, 14000
Study site
Mexico City, 14080
Russia4 sites
Study site
Kazan', 420029
Study site
Moscow, 115478
Study site
Saint Petersburg, 197758
Study site
Ufa, 450054
South Korea4 sites
Study site
Seoul, 135-170
Study site
Seoul, 135-720
Study site
Seoul, 138-736
Study site
Seoul, 405-760
Argentina3 sites
Study site
Buenos Aires, C1264AAA
Study site
Buenos Aires, C1270AAE
Study site
Rosario, S2000PBJ
Belize1 site
Study site
Tegucigalpa
About this study
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
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.
- Conditions
- Gastric Cancer
- Being tested
- 5-Fluorouracil, Capecitabine, Cisplatin
- Medical subject headings
- Stomach Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
5-FluorouracilDrug
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.
CapecitabineDrug
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.
CisplatinDrug
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.
| Study group | Role | What they receive |
|---|---|---|
| 5-Fluorouracil + Cisplatin | Active comparator | Participants will receive 5-FU in combination with cisplatin upto disease progression. Receives: Drug: 5-Fluorouracil; Drug: Cisplatin |
| Capecitabine + Cisplatin | Experimental | Participants will receive capecitabine in combination with cisplatin upto disease progression. Receives: Drug: Capecitabine; Drug: Cisplatin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time to disease progression
Measured: Up to approximately 7.3 years
Secondary outcomes (5)
Objective tumor response rate
Measured: Up to approximately 7.3 years
Overall survival
Measured: Up to approximately 7.3 years
Duration of response
Measured: Up to approximately 7.3 years
Time to response
Measured: Up to approximately 7.3 years
Incidence of adverse events
Measured: Up to approximately 7.3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Sep 2015 (estimated)
- Study startApr 2003
- Primary completionAug 2010
- Study completionAug 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Gastric CancerStudies of the same condition, open and under way.
- More trials run by Hoffmann-La RocheThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 316 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hoffmann-La Roche
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Clinical Trials, Study chair, Hoffmann-La Roche
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02563054
- Sponsor's protocol ID
- ML17032
- Status last verified
- Nov 2016
- First submitted
- 28 Sep 2015
- Last updated
- 2 Nov 2016
- Results posted
- No
Publications
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.
PubMed 29372626
Study at a glance
From the registry record, last updated by the sponsor on 2 Nov 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT02563054
- Acronym / sponsor ID
- ML17032
- Conditions
- Gastric Cancer
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 316 participants (actual)
- Lead sponsor
- Hoffmann-La RocheIndustry (pharma, biotech, devices)
- Study start
- Apr 2003
- Primary completion
- Aug 2010 (actual)
- Study completion
- Aug 2010 (actual)
- First posted
- 29 Sep 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 5-Fluorouracil + Cisplatin | Active comparator | Drug: 5-Fluorouracil, Drug: CisplatinParticipants will receive 5-FU in combination with cisplatin upto disease progression. |
| Capecitabine + Cisplatin | Experimental | Drug: Capecitabine, Drug: CisplatinParticipants will receive capecitabine in combination with cisplatin upto disease progression. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Adults 18 to 75 years of age
- Advanced and/or metastatic gastric cancer with at least 1 measurable lesion
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 5-FluorouracilParticipants 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. | Drug | 5-Fluorouracil + Cisplatin |
| CapecitabineParticipants 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. | Drug | Capecitabine + Cisplatin |
| CisplatinParticipants 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. | Drug | 5-Fluorouracil + Cisplatin, Capecitabine + Cisplatin |
Primary outcome
Time to disease progression
Time frame: Up to approximately 7.3 years
5 secondary outcomes
Objective tumor response rate
Time frame: Up to approximately 7.3 years
Overall survival
Time frame: Up to approximately 7.3 years
Duration of response
Time frame: Up to approximately 7.3 years
Time to response
Time frame: Up to approximately 7.3 years
Incidence of adverse events
Time frame: Up to approximately 7.3 years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Nov 2016.
- Derived from this study: PubMed 29372626Chen 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Clinical Trials study chair
Hoffmann-La Roche
45 sites in 14 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing 5-Fluorouracil, Capecitabine and Cisplatin in people with Gastric Cancer, run by Hoffmann-La Roche at 45 sites in 14 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 2 Nov 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 45 sites in China, Brazil, Mexico, Russia, South Korea and 9 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Time to disease progression (time frame: Up to approximately 7.3 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02563054, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Nov 2016.