Gastric CancerPhase 3NCT02560974
A Study of Capecitabine (Xeloda) in Combination Chemotherapy Versus Surgery Alone in Participants With Gastric Cancer
A Phase 3 study testing Capecitabine and Oxaliplatin in people with Gastric Cancer, run by Hoffmann-La Roche at 36 sites in 3 countries.
Trial summary
This study will compare capecitabine/oxaliplatin as adjuvant chemotherapy versus observation alone in chemotherapy-naive participants who have undergone potentially curative resection for gastric cancer. Participants will be randomized to either the chemotherapy arm or the observation arm. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Gastric Cancer
- What is being tested?
- Capecitabine and Oxaliplatin
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,035 participants
- Where
- 36 sitesin 3 countries
- Study dates
- Jun 2006to Nov 2012
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adult participants greater than or equal to (>=) 18 years of age
- Gastric adenocarcinoma, Stage II, IIIa or IIIb
- Potentially curative resection of tumor within 6 weeks prior to randomization
- Previously untreated with chemotherapy or radiotherapy
Who cannot join
- Serious concomitant medical illnesses that would limit life expectancy to less than (<) 5 years
- Sexually active males and females (of childbearing potential) unwilling to practice contraception during the study
- Any evidence of metastatic disease (including presence of tumor cells in the ascites)
Trial locations and contacts
36 sites in 3 countries.
36 sites in 3 countries
South Korea21 sites
Study site
Bundang City, 463-802
Study site
Busan, 49267
Study site
Daegu, 700-712
Study site
Daegu, 702-210
Study site
Daegu
Study site
Gyeonggi-do, 10408
Study site
Gyeonggi-do, 443-380
Study site
Incheon, 405-760
Study site
Jeollabuk-do, 561-712
Study site
Jeollanam-do, 58128
Study site
Seoul, 03080
Study site
Seoul, 120-752
Study site
Seoul, 130-872
Study site
Seoul, 134-791
Study site
Seoul, 135-720
Study site
Seoul, 139-709
Study site
Seoul, 140-743
Study site
Seoul, 152-703
Study site
Seoul, 158-710
Study site
Seoul
Study site
Suwon
China9 sites
Study site
Beijing, 100044
Study site
Beijing, 100142
Study site
Fujian, 350001
Study site
Guangzhou, 510060
Study site
Guangzhou, 510080
Study site
Shanghai, 200025
Study site
Shanghai, 200032
Study site
Shenyang, 110001
Study site
Tianjin, 300060
Taiwan6 sites
Study site
Changhua, 500
Study site
Tainan, 704
Study site
Taipei, 00112
Study site
Taipei, 104
Study site
Taipei
Study site
Taoyuan, 333
About this study
Official title: A Phase III Study Comparing Adjuvant Chemotherapy Consisting of Capecitabine/Oxaliplatin Versus Surgery Alone in Patients With Stage II (T1N2, T2N1, T3N0), IIIa (T2N2, T3N1, T4N0) and IIIb (T3N2) Gastric Adenocarcinoma
This study will compare capecitabine/oxaliplatin as adjuvant chemotherapy versus observation alone in chemotherapy-naive participants who have undergone potentially curative resection for gastric cancer. Participants will be randomized to either the chemotherapy arm or the observation arm. Capecitabine will be administered orally, 1000 milligrams per meter-squared (mg/m^2) twice daily (BID) on Days 1 to 15 of a 3-week cycle, for 8 cycles, and oxaliplatin will be administered as an intravenous (IV) infusion, 130 mg/m^2 every 3 weeks for 8 cycles. The anticipated time on study treatment in 6 months and the target sample size is 1024 individuals.
- Conditions
- Gastric Cancer
- Being tested
- Capecitabine, Oxaliplatin
- Medical subject headings
- Stomach Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CapecitabineDrug
Also called Xeloda
Capecitabine will be administered orally at 1000 mg/m^2 BID on Days 1 to 15 of a 3-week cycle, for 8 cycles.
OxaliplatinDrug
Oxaliplatin will be administered as an IV infusion, 130 mg/m^2 on Day 1 of each 3-week cycle for 8 cycles.
| Study group | Role | What they receive |
|---|---|---|
| Capecitabine + Oxaliplatin | Experimental | Patients will receive oral capecitabine (1000 mg/m^2 BID on Days 1 to 15 ) plus IV oxaliplatin (130 mg/m^2 on Day 1) during each 3-week cycle for up to 8 cycles (6 months). Receives: Drug: Capecitabine; Drug: Oxaliplatin |
| Observation | No intervention | Participants will not receive any treatment but will be seen regularly by a physician. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Disease-free survival rate
Measured: 3 years
Secondary outcomes (2)
Overall survival
Measured: 5 years
Incidence of adverse events
Measured: 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Sep 2015 (estimated)
- Study startJun 2006
- Primary completionNov 2012
- Study completionNov 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 1,035 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
- NCT02560974
- Sponsor's protocol ID
- MO17527
- Status last verified
- Nov 2016
- First submitted
- 24 Sep 2015
- Last updated
- 2 Nov 2016
- Results posted
- No
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
- A Phase III Study Comparing Adjuvant Chemotherapy Consisting of Capecitabine/Oxaliplatin Versus Surgery Alone in Patients With Stage II (T1N2, T2N1, T3N0), IIIa (T2N2, T3N1, T4N0) and IIIb (T3N2) Gastric Adenocarcinoma
- ClinicalTrials.gov ID
- NCT02560974
- Acronym / sponsor ID
- MO17527
- Conditions
- Gastric Cancer
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1,035 participants (actual)
- Lead sponsor
- Hoffmann-La RocheIndustry (pharma, biotech, devices)
- Study start
- Jun 2006
- Primary completion
- Nov 2012 (actual)
- Study completion
- Nov 2012 (actual)
- First posted
- 25 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 compare capecitabine/oxaliplatin as adjuvant chemotherapy versus observation alone in chemotherapy-naive participants who have undergone potentially curative resection for gastric cancer. Participants will be randomized to either the chemotherapy arm or the observation arm. Capecitabine will be administered orally, 1000 milligrams per meter-squared (mg/m^2) twice daily (BID) on Days 1 to 15 of a 3-week cycle, for 8 cycles, and oxaliplatin will be administered as an intravenous (IV) infusion, 130 mg/m^2 every 3 weeks for 8 cycles. The anticipated time on study treatment in 6 months and the target sample size is 1024 individuals.
Study design
- Primary purpose
- Treatment
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Capecitabine + Oxaliplatin | Experimental | Drug: Capecitabine, Drug: OxaliplatinPatients will receive oral capecitabine (1000 mg/m^2 BID on Days 1 to 15 ) plus IV oxaliplatin (130 mg/m^2 on Day 1) during each 3-week cycle for up to 8 cycles (6 months). |
| Observation | No intervention | –Participants will not receive any treatment but will be seen regularly by a physician. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Adult participants greater than or equal to (>=) 18 years of age
- Gastric adenocarcinoma, Stage II, IIIa or IIIb
- Potentially curative resection of tumor within 6 weeks prior to randomization
- Previously untreated with chemotherapy or radiotherapy
Key exclusion criteria (3 listed)
- Serious concomitant medical illnesses that would limit life expectancy to less than (<) 5 years
- Sexually active males and females (of childbearing potential) unwilling to practice contraception during the study
- Any evidence of metastatic disease (including presence of tumor cells in the ascites)
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 |
|---|---|---|
| CapecitabineAlso: XelodaCapecitabine will be administered orally at 1000 mg/m^2 BID on Days 1 to 15 of a 3-week cycle, for 8 cycles. | Drug | Capecitabine + Oxaliplatin |
| OxaliplatinOxaliplatin will be administered as an IV infusion, 130 mg/m^2 on Day 1 of each 3-week cycle for 8 cycles. | Drug | Capecitabine + Oxaliplatin |
Primary outcome
Disease-free survival rate
Time frame: 3 years
2 secondary outcomes
Overall survival
Time frame: 5 years
Incidence of adverse events
Time frame: 5 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.
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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
36 sites in 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Capecitabine and Oxaliplatin in people with Gastric Cancer, run by Hoffmann-La Roche at 36 sites in 3 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 4 inclusion and 3 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 36 sites in South Korea, China, Taiwan. 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?
Disease-free survival rate (time frame: 3 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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.