Gastric CancerPhase 3NCT03399110
XELOX for 4 Months Versus 6 Months in Gastric Cancer (LOMAC)
A Phase 3 study testing Oxaliplatin and Capecitabine in people with Gastric Cancer, run by Fudan University at 10 sites in China.
Trial summary
Our study aims to compare 4 months versus 6 months of adjuvant capecitabine plus oxaliplatin after D2 gastrectomy in patients with gastric cancer. Hypothesis: We hypothesize that a 4-month regimen of capecitabine plus oxaliplatin is noninferior to a 6-month regimen with respect to DFS and is associated with lower… Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Gastric Cancer
- What is being tested?
- Oxaliplatin and Capecitabine
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,024 participants
- Where
- 10 sitesChina
- Study dates
- 14 Jan 2018to 15 Aug 2026
- 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 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age between 18 and 80 years.
- Histologically confirmed adenocarcinoma of the stomach or gastroesophageal junction, staged as II, IIIA, or IIIB according to the American Joint Committee on Cancer classification system, eighth edition.
- Underwent R0 gastrectomy with D2 lymphadenectomy.
- No other concurrent malignancies.
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
- No contraindications to chemotherapy.
Who cannot join
- Receipt of preoperative treatment, including radiation therapy, chemotherapy, or immunotherapy.
- Patients with stage I, IIIC, or IV gastric cancer.
- Severe cardiac, pulmonary, neurologic, hepatic, or other major organ dysfunction.
- Known or suspected drug allergies.
- Pregnant or lactating women.
Trial locations and contacts
10 sites in 1 country.
10 sites in 1 country
China10 sites
Sun Yat-sen University Cancer Center
Guangzhou
The First Affiliated Hospital of Anhui Medical University
Hefei
The First Affiliated Hospital of University of Science and Technology of China
Hefei
Jiangsu Cancer Hospital
Nanjing
Changhai Hospital
Shanghai
Fudan University Shanghai Cancer Center
Shanghai
Second Affiliated Hospital (Changzheng Hospital) of Naval Medical University
Shanghai
Shanghai East Hospital
Shanghai
Liaoning Cancer Hospital
Shenyang
The First Affiliated Hospital of Wannan Medical College
Wuhu
About this study
Official title: XELOX for 4 Months Versus 6 Months as Adjuvant Chemotherapy in Gastric Cancer After D2 Resection (LOMAC)
Our study aims to compare 4 months versus 6 months of adjuvant capecitabine plus oxaliplatin after D2 gastrectomy in patients with gastric cancer.
Hypothesis: We hypothesize that a 4-month regimen of capecitabine plus oxaliplatin is noninferior to a 6-month regimen with respect to DFS and is associated with lower treatment-related toxicity.
Read the detailed description
Surgical resection is the cornerstone of treatment for patients with localized gastric cancer. In the CLASSIC trial, capecitabine plus oxaliplatin for 6 months following D2 gastrectomy has been established as a standard postoperative adjuvant treatment for patients with operable stage II or III gastric cancer. However, due to adverse events, chemotherapy was discontinued in 50 patients (10%), primarily due to nausea, neutropenia, decreased appetite, peripheral neuropathy, diarrhea, and vomiting. At the 2017 ASCO Annual Meeting, Grothey et al. reported the results of the IDEA trial. For patients with lymph node-positive colon cancer (stage III), some patients may benefit from a shorter duration of postoperative chemotherapy. An analysis of six clinical trials involving over 12,800 patients showed that 3 months of chemotherapy was nearly as effective as 6 months for patients with a lower recurrence risk, while also causing fewer side effects, particularly nerve damage. Based on the findings from the IDEA trial, we hypothesize that a 4-month regimen of capecitabine plus oxaliplatin may also benefit patients following D2 gastrectomy while reducing adverse events compared with the standard 6-month regimen.
- Conditions
- Gastric Cancer
- Being tested
- Oxaliplatin, Capecitabine
- Keywords
- Adjuvant chemotherapy, Gastric Cancer, Non-inferiority, 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.
OxaliplatinDrug
Also called Eloxatin
Oxaliplatin 130 mg/m2
CapecitabineDrug
Also called Xeloda
Capecitabine 1000 mg/m2
| Study group | Role | What they receive |
|---|---|---|
| XELOX for 4 months | Experimental | Adjuvant chemotherapy with capecitabine and oxaliplatin after surgery consists of 6 cycles (A minimum of 5 cycles was permitted only for patients who could not tolerate full-dose therapy due to unacceptable toxicity), each lasting 3 weeks: oral capecitabine at 1000 mg/m² twice daily on days 1-14, combined with intravenous oxaliplatin at 130 mg/m² on day 1, administered for approximately 4 months. Receives: Drug: Oxaliplatin; Drug: Capecitabine |
| XELOX for 6 months | Active comparator | Adjuvant chemotherapy with capecitabine and oxaliplatin after surgery consists of eight 3-week cycles: oral capecitabine at 1000 mg/m² twice daily on days 1-14, combined with intravenous oxaliplatin at 130 mg/m² on day 1, administered for 6 months. Receives: Drug: Oxaliplatin; Drug: Capecitabine |
What is being measured
The primary outcome is the main question the study is designed to answer.
DFS
Disease-free survival, defined as the time from randomization to the first occurrence of disease recurrence or death from any cause.
Measured: 3 years
Secondary outcomes (2)
Adverse Events
Adverse Events of Chemotherapy
Measured: 6 months
OS
Overall survival, defined as the time from randomization to death from any cause.
Measured: 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jan 2018
- Study start14 Jan 2018
- Primary completion15 Aug 2026
- Study completion15 Aug 2026
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 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
- 1,024 participants (actual)
Sponsor and investigators
- Lead sponsor
- Fudan University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dazhi Xu, Fudan University
- Investigators
- Dazhi Xu, PHD, MD, Principal investigator, Fudan University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03399110
- Sponsor's protocol ID
- LOMAC
- Status last verified
- Aug 2026
- First submitted
- 8 Jan 2018
- Last updated
- 24 Aug 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Deidentified individual participant data underlying the results reported in the primary publication will be made available to qualified researchers upon reasonable request and approval by the study investigators.
Study at a glance
From the registry record, last updated by the sponsor on 24 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- XELOX for 4 Months Versus 6 Months as Adjuvant Chemotherapy in Gastric Cancer After D2 Resection (LOMAC)
- ClinicalTrials.gov ID
- NCT03399110
- Acronym / sponsor ID
- LOMAC
- Conditions
- Gastric Cancer
- Keywords
- Adjuvant chemotherapy, Gastric Cancer, Non-inferiority, Oxaliplatin, Capecitabine
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1,024 participants (actual)
- Lead sponsor
- Fudan UniversityUniversity, hospital or other
- Study start
- 14 Jan 2018 (actual)
- Primary completion
- 15 Aug 2026 (actual)
- Study completion
- 15 Aug 2026 (actual)
- First posted
- 16 Jan 2018 (actual)
- 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.
Our study aims to compare 4 months versus 6 months of adjuvant capecitabine plus oxaliplatin after D2 gastrectomy in patients with gastric cancer.
Hypothesis: We hypothesize that a 4-month regimen of capecitabine plus oxaliplatin is noninferior to a 6-month regimen with respect to DFS and is associated with lower treatment-related toxicity.
Detailed description
Surgical resection is the cornerstone of treatment for patients with localized gastric cancer. In the CLASSIC trial, capecitabine plus oxaliplatin for 6 months following D2 gastrectomy has been established as a standard postoperative adjuvant treatment for patients with operable stage II or III gastric cancer. However, due to adverse events, chemotherapy was discontinued in 50 patients (10%), primarily due to nausea, neutropenia, decreased appetite, peripheral neuropathy, diarrhea, and vomiting. At the 2017 ASCO Annual Meeting, Grothey et al. reported the results of the IDEA trial. For patients with lymph node-positive colon cancer (stage III), some patients may benefit from a shorter duration of postoperative chemotherapy. An analysis of six clinical trials involving over 12,800 patients showed that 3 months of chemotherapy was nearly as effective as 6 months for patients with a lower recurrence risk, while also causing fewer side effects, particularly nerve damage. Based on the findings from the IDEA trial, we hypothesize that a 4-month regimen of capecitabine plus oxaliplatin may also benefit patients following D2 gastrectomy while reducing adverse events compared with the standard 6-month regimen.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| XELOX for 4 months | Experimental | Drug: Oxaliplatin, Drug: CapecitabineAdjuvant chemotherapy with capecitabine and oxaliplatin after surgery consists of 6 cycles (A minimum of 5 cycles was permitted only for patients who could not tolerate full-dose therapy due to unacceptable toxicity), each lasting 3 weeks: oral capecitabine at 1000 mg/m² twice daily on days 1-14, combined with intravenous oxaliplatin at 130 mg/m² on day 1, administered for approximately 4 months. |
| XELOX for 6 months | Active comparator | Drug: Oxaliplatin, Drug: CapecitabineAdjuvant chemotherapy with capecitabine and oxaliplatin after surgery consists of eight 3-week cycles: oral capecitabine at 1000 mg/m² twice daily on days 1-14, combined with intravenous oxaliplatin at 130 mg/m² on day 1, administered for 6 months. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Age between 18 and 80 years.
- Histologically confirmed adenocarcinoma of the stomach or gastroesophageal junction, staged as II, IIIA, or IIIB according to the American Joint Committee on Cancer classification system, eighth edition.
- Underwent R0 gastrectomy with D2 lymphadenectomy.
- No other concurrent malignancies.
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
Key exclusion criteria (5 listed)
- Receipt of preoperative treatment, including radiation therapy, chemotherapy, or immunotherapy.
- Patients with stage I, IIIC, or IV gastric cancer.
- Severe cardiac, pulmonary, neurologic, hepatic, or other major organ dysfunction.
- Known or suspected drug allergies.
- Pregnant or lactating women.
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 |
|---|---|---|
| OxaliplatinAlso: EloxatinOxaliplatin 130 mg/m2 | Drug | XELOX for 4 months, XELOX for 6 months |
| CapecitabineAlso: XelodaCapecitabine 1000 mg/m2 | Drug | XELOX for 4 months, XELOX for 6 months |
Primary outcome
DFS
Time frame: 3 years
Disease-free survival, defined as the time from randomization to the first occurrence of disease recurrence or death from any cause.
2 secondary outcomes
Adverse Events
Time frame: 6 months
OS
Time frame: 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 24 Aug 2026.
- Individual participant dataSharing planned: Yes. Deidentified individual participant data underlying the results reported in the primary publication will be made available to qualified researchers upon reasonable request and approval by the study investigators.
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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.
Dazhi Xu, PHD, MD principal investigator
Fudan University
10 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Oxaliplatin and Capecitabine in people with Gastric Cancer, run by Fudan University at 10 sites in China.
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 6 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 24 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 10 sites 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?
DFS (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 24 Aug 2026.