Gastric CancerPhase 3NCT02395640
The Comparison of XELOX and EOX in the First-line Treatment of Advanced Gastric Cancer
A Phase 3 study testing Epirubicin, Oxaliplatin and Capecitabine in people with Gastric Cancer, run by Fudan University at 1 site in China.
Trial summary
This study is designed to compare the efficacy and safety of XELOX regimen with EOX regimen in the first-line treatment of advanced gastric cancer patients. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Gastric Cancer
- What is being tested?
- Epirubicin, Oxaliplatin and Capecitabine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 438 participants
- Where
- 1 siteChina
- Study dates
- Mar 2015to 23 Feb 2021
- 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 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Major inclusion criteria
- had a histologically proven adenocarcinoma of the gastroesophageal junction, or stomach that was locally advanced (inoperable) or metastatic
- measurable disease, according to the Response Evaluation Criteria in Solid Tumors (RECIST)1.1
- an Eastern Cooperative Oncology Group performance status of 0 to 2
- adequate renal, hepatic, and hematologic function
Major exclusion criteria
- previous chemotherapy or radiotherapy (unless in the adjuvant setting)
- uncontrolled cardiac disease, or other clinically significant, uncontrolled coexisting illness or previous or concurrent cancer
- accumulated dose of Epirubicin exceeds 300mg/m2
- HER2 positive and willing to use trastuzumab
Trial locations and contacts
1 site in 1 country.
China1 site
Fudan University Cancer Hospital
Shanghai, Shanghai Municipality, 200032
About this study
Official title: The Comparison of XELOX and EOX in the First-line Treatment of Advanced Gastric Cancer: An Open-label, Multi-center, Prospective and Randomised Study
This study is designed to compare the efficacy and safety of XELOX regimen with EOX regimen in the first-line treatment of advanced gastric cancer patients.
Read the detailed description
This study is designed to compare the efficacy and safety of XELOX regimen with EOX regimen in the first-line treatment of advanced gastric cancer patients.
- Conditions
- Gastric Cancer
- Being tested
- Epirubicin, Oxaliplatin, Capecitabine
- Medical subject headings
- Stomach Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EpirubicinDrug
50mg/m2 ivgtt d1
OxaliplatinDrug
Also called 130mg/m2 ivgtt d1
CapecitabineDrug
Also called Xeloda
1000mg/m2 po d1-14
| Study group | Role | What they receive |
|---|---|---|
| XELOX | Experimental | oxaliplatin 130mg/m2 d1； capecitabine 1000mg/m2 Bid po，d1-14； Receives: Drug: Oxaliplatin; Drug: Capecitabine |
| EOX | Active comparator | Epirubicin 50mg/m2 d1； oxaliplatin 130mg/m2 d1； capecitabine 1000mg/m2 Bid po，d1-14； Receives: Drug: Epirubicin; Drug: Oxaliplatin; Drug: Capecitabine |
What is being measured
The primary outcome is the main question the study is designed to answer.
progression free survival
Measured: 7 months
Secondary outcomes (4)
overall survival
Measured: 10 months
overall response rate
Measured: 2 months
Number of Participants with Adverse Events
Measured: 2 months
quality of life questionnaire
Measured: 2 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Mar 2015 (estimated)
- Study startMar 2015
- Primary completion23 Feb 2021
- Study completion23 Feb 2021
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 Fudan UniversityThe 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
- 438 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Fudan University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Weijian Guo, Fudan University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02395640
- Sponsor's protocol ID
- FDZL-EXELOX
- Status last verified
- Mar 2015
- First submitted
- 10 Mar 2015
- Last updated
- 26 Oct 2021
- Results posted
- No
- Data monitoring committee
- No
Publications
Zhu XD, Huang MZ, Wang YS, Feng WJ, Chen ZY, He YF, Zhang XW, Liu X, Wang CC, Zhang W, Ying JE, Wu J, Yang L, Qin YR, Luo JF, Zhao XY, Li WH, Zhang Z, Qiu LX, Geng QR, Zou JL, Zhang JY, Zheng H, Song XF, Wu SS, Zhang CY, Gong Z, Liu QQ, Wang XF, Xu Q, Wang Q, Ji JM, Zhao J, Guo WJ. XELOX doublet regimen versus EOX triplet regimen as first-line treatment for advanced gastric cancer: An open-labeled, multicenter, randomized, prospective phase III trial (EXELOX). Cancer Commun (Lond). 2022 Apr;42(4):314-326. doi: 10.1002/cac2.12278. Epub 2022 Feb 25.
PubMed 35212487
Study at a glance
From the registry record, last updated by the sponsor on 26 Oct 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Comparison of XELOX and EOX in the First-line Treatment of Advanced Gastric Cancer: An Open-label, Multi-center, Prospective and Randomised Study
- ClinicalTrials.gov ID
- NCT02395640
- Acronym / sponsor ID
- FDZL-EXELOX
- Conditions
- Gastric Cancer
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 438 participants (estimated)
- Lead sponsor
- Fudan UniversityUniversity, hospital or other
- Study start
- Mar 2015
- Primary completion
- 23 Feb 2021 (actual)
- Study completion
- 23 Feb 2021 (actual)
- First posted
- 23 Mar 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 is designed to compare the efficacy and safety of XELOX regimen with EOX regimen in the first-line treatment of advanced gastric cancer patients.
Detailed description
This study is designed to compare the efficacy and safety of XELOX regimen with EOX regimen in the first-line treatment of advanced gastric cancer patients.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| XELOX | Experimental | Drug: Oxaliplatin, Drug: Capecitabineoxaliplatin 130mg/m2 d1； capecitabine 1000mg/m2 Bid po，d1-14； |
| EOX | Active comparator | Drug: Epirubicin, Drug: Oxaliplatin, Drug: CapecitabineEpirubicin 50mg/m2 d1； oxaliplatin 130mg/m2 d1； capecitabine 1000mg/m2 Bid po，d1-14； |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
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 |
|---|---|---|
| Epirubicin50mg/m2 ivgtt d1 | Drug | EOX |
| OxaliplatinAlso: 130mg/m2 ivgtt d1 | Drug | EOX, XELOX |
| CapecitabineAlso: Xeloda1000mg/m2 po d1-14 | Drug | EOX, XELOX |
Primary outcome
progression free survival
Time frame: 7 months
4 secondary outcomes
overall survival
Time frame: 10 months
overall response rate
Time frame: 2 months
Number of Participants with Adverse Events
Time frame: 2 months
quality of life questionnaire
Time frame: 2 months
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 26 Oct 2021.
- Derived from this study: PubMed 35212487Zhu XD, Huang MZ, Wang YS, Feng WJ, Chen ZY, He YF, Zhang XW, Liu X, Wang CC, Zhang W, Ying JE, Wu J, Yang L, Qin YR, Luo JF, Zhao XY, Li WH, Zhang Z, Qiu LX, Geng QR, Zou JL, Zhang JY, Zheng H, Song XF, Wu SS, Zhang CY, Gong Z, Liu QQ, Wang XF, Xu Q, Wang Q, Ji JM, Zhao J, Guo WJ. XELOX doublet regimen versus EOX triplet regimen as first-line treatment for advanced gastric cancer: An open-labeled, multicenter, randomized, prospective phase III trial (EXELOX). Cancer Commun (Lond). 2022 Apr;42(4):314-326. doi: 10.1002/cac2.12278. Epub 2022 Feb 25.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Epirubicin, Oxaliplatin and Capecitabine in people with Gastric Cancer, run by Fudan University at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
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 26 Oct 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. 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?
progression free survival (time frame: 7 months). 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 NCT02395640, 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 26 Oct 2021.