Gastric CancerPhase 3Neo-CRAGNCT01815853
Neoadjuvant Chemoradiotherapy vs. Chemotherapy Followed by Radical Gastrectomy and Adjuvant Chemotherapy for Advanced Gastric Cancer
A Phase 3 study testing Neoadjuvant Chemoradiotherapy, Neoadjuvant Chemotherapy and R0 D2 Gastrectomy in people with Gastric Cancer, run by Sun Yat-sen University at 1 site in China.
Trial summary
Patients with histologically confirmed gastric adenocarcinoma with locally advanced gastric cancer are randomized in a 1:1 ratio to receive neoadjuvant chemoradiotherapy with DT45Gy/25f plus three cycles of XELOX therapy or neoadjuvant chemotherapy alone using XELOX regimen following D2 gastrectomy and adjuvant… 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?
- Neoadjuvant Chemoradiotherapy, Neoadjuvant Chemotherapy and R0 D2 Gastrectomy
- Type of treatment
- Pill or oral medicine, Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 620 participants
- Where
- 1 siteChina
- Study dates
- Jun 2013to Jun 2025
- 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
- Histologically confirmed gastric cancer with clinical staging determined by endoscopic ultrasound and contrast-enhanced CT or MRI as cT3N2/N3M0, cT4aN+M0, or cT4bNanyM0.
- Good general condition, with Eastern Cooperative Oncology Group (ECOG) performance status <2 and no contraindications to surgery.
- Ambulatory male or female patients aged 18 to 75 years.
- Sufficient physical fitness and organ function to tolerate major abdominal surgery.
- Baseline laboratory parameters meeting the following criteria: WBC > 4.0 × 10⁹/L, ANC > 1.5 × 10⁹/L, Hb ≥ 100 g/L, PLT ≥ 100 × 10⁹/L, total bilirubin ≤ 1.5 × upper limit of normal (ULN), AST and ALT ≤ 2.5 × ULN, and serum creatinine ≤ 1.0 × ULN.
- No prior or concurrent diagnosis of other malignancies.
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- Willing and able to comply with study protocol requirements during the trial period.
- Provided written informed consent prior to screening, with full awareness of the right to withdraw from the study at any time without consequence.
- Estimated life expectancy of at least 3 months.
Who cannot join
- Pregnant or breastfeeding women, or women of childbearing potential not using effective contraception.
- Receipt of any antitumor therapy prior to surgery.
- History of or concurrent malignancies other than gastric cancer.
- Presence of psychiatric disorders, brain metastases, or leptomeningeal metastases.
- Uncontrolled or severe comorbid conditions or active infections.
- Decompensated dysfunction of major organs (e.g., cardiac, pulmonary, hepatic, or renal failure).
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- Concurrent participation in another clinical trial.
- Contraindications to chemotherapy, radiotherapy, or surgery.
- Active hepatitis B or hepatitis C virus infection.
- Grade ≥2 peripheral neuropathy (per NCI-CTCAE).
- Chronic intestinal diseases or short bowel syndrome.
- Known dihydropyrimidine dehydrogenase (DPD) deficiency.
- Known hypersensitivity to capecitabine or any of its excipients.
- Ongoing treatment with sorivudine or related analogs.
- Deemed unsuitable for participation in this clinical trial by the investigator.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Randomized, Open-Label, Multicenter, Controlled Phase III Trial Comparing Neoadjuvant Chemoradiotherapy Followed by Surgery and Adjuvant Chemotherapy Versus Neoadjuvant Chemotherapy Followed by Surgery and Adjuvant Chemotherapy in Patients With Locally Advanced Gastric Cancer
Patients with histologically confirmed gastric adenocarcinoma with locally advanced gastric cancer are randomized in a 1:1 ratio to receive neoadjuvant chemoradiotherapy with DT45Gy/25f plus three cycles of XELOX therapy or neoadjuvant chemotherapy alone using XELOX regimen following D2 gastrectomy and adjuvant chemotherapy for 3 cycles. The primary end point is 3-year disease free survival (DFS), and secondary end point is 5-year overall survival (OS), R0 resection rate, pathological complete remission (pCR) and treatment safety.
Read the detailed description
Background: Literatures have shown that patients with locally advanced gastric cancer could potentially benefit from neoadjuvant chemoradiotherapy, but whether this can improve patients' outcome is still unclear.
Patients and methods: In this study , patients with histologically confirmed gastric adenocarcinoma with pre-operative staging are cT3N2/N3M0, cT4aN+M0 and cT4bNanyM0, aged between 18-75 years old, with adequate organ function and having an Eastern Cooperative Oncology Group performance status score ≤2, are randomized in a 1:1 ratio to receive neoadjuvant chemoradiotherapy with DT45Gy/25f plus three cycles of XELOX therapy [Oxaliplatin 130 mg/m² IV on Day 1 + Capecitabine 1000 mg/m² orally BID on Days 1-14 of a 21-day cycle (non-concurrent); Oxaliplatin 100 mg/m² IV on Day 1 + Capecitabine 825 mg/m² orally BID on Days 1-14 of a 21-day cycle (concurrent chemoradiotherapy)] or neoadjuvant chemotherapy alone using XELOX regimen (Oxaliplatin 130 mg/m² IV on Day 1 + Capecitabine 1000 mg/m² orally BID on Days 1-14 of a 21-day cycle) following by D2 gastrectomy and adjuvant chemotherapy with same dosage of XELOX therapy for up to 3 cycles. The primary end point is 3-year disease free survival (DFS), and secondary end point is 5-year overall survival (OS), R0 resection rate, pathological complete remission (pCR) and treatment safety. The final study analytics are to be conducted at the end of the 5th year after the last patient's enrollment.
- Conditions
- Gastric Cancer
- Being tested
- Neoadjuvant Chemoradiotherapy, Neoadjuvant Chemotherapy, R0 D2 Gastrectomy, Adjuvant Chemotherapy
- Keywords
- Neoadjuvant, Chemoradiotherapy, Chemotherapy, Locally advanced gastric cancer, Pathological complete response, D2 gastrectomy
- Medical subject headings
- Stomach Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Neoadjuvant ChemoradiotherapyRadiation
Radiotherapy (45Gy/25f) + 3 cycles of XELOX Chemotherapy [Oxaliplatin 130 mg/m² IV on Day 1 + Capecitabine 1000 mg/m² orally BID on Days 1-14 of a 21-day cycle (non-concurrent); Oxaliplatin 100 mg/m² IV on Day 1 + Capecitabine 825 mg/m² orally BID on Days 1-14 of a 21-day cycle (concurrent chemoradiotherapy)]
Neoadjuvant ChemotherapyDrug
3 cycles of XELOX Chemotherapy (Oxaliplatin 130 mg/m² IV on Day 1 + Capecitabine 1000 mg/m² orally BID on Days 1-14 of a 21-day cycle)
R0 D2 GastrectomyProcedure or surgery
Adjuvant ChemotherapyDrug
3 cycles of XELOX Chemotherapy (Oxaliplatin 130 mg/m² IV on Day 1 + Capecitabine 1000 mg/m² orally BID on Days 1-14 of a 21-day cycle)
| Study group | Role | What they receive |
|---|---|---|
| Neoadjuvant Chemoradiotherapy | Experimental | Radiotherapy (45Gy/25f) + 3 cycles of XELOX Chemotherapy [Oxaliplatin 130 mg/m² IV on Day 1 + Capecitabine 1000 mg/m² orally BID on Days 1-14 of a 21-day cycle (non-concurrent); Oxaliplatin 100 mg/m² IV on Day 1 + Capecitabine 825 mg/m² orally BID on Days 1-14 of a 21-day cycle (concurrent chemoradiotherapy) ] following with D2 Gastrectomy and 3 cycles of Adjuvant XELOX Chemotherapy Receives: Radiation: Neoadjuvant Chemoradiotherapy; Procedure: R0 D2 Gastrectomy; Drug: Adjuvant Chemotherapy |
| Neoadjuvant Chemotherapy | Active comparator | 3 cycles of XELOX Chemotherapy (Oxaliplatin 130 mg/m² IV on Day 1 + Capecitabine 1000 mg/m² orally BID on Days 1-14 of a 21-day cycle) following with D2 Gastrectomy and 3 cycles of Adjuvant XELOX Chemotherapy Receives: Drug: Neoadjuvant Chemotherapy; Procedure: R0 D2 Gastrectomy; Drug: Adjuvant Chemotherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Disease-free Survival
3-year DFS
Measured: 3 years
Secondary outcomes (4)
Overall Survival
5-year Overall Survival
Measured: 5 years
Pathological Complete Remission
pCR
Measured: Peri-operative period
Radical Resection Rate
R0 Resection Rate
Measured: Peri-operative period
Adverse effects
Treatment safety
Measured: Peri-operative period
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Mar 2013 (estimated)
- Study startJun 2013
- Primary completionJun 2025
- Study completionJun 2025
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 Sun Yat-sen 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
- Model description
- Neoadjuvant Chemoradiotherapy versus Neoadjuvant Chemotherapy
- Masking
- None (open label)
- Enrolment
- 620 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sun Yat-sen University
- Sponsor type
- University, hospital or other
- Collaborators
- The First Affiliated Hospital of Anhui Medical University, Liaoning Cancer Hospital & Institute, Guangdong Provincial Hospital of Traditional Chinese Medicine, Tianjin Medical University Cancer Institute and Hospital, Zhejiang Cancer Hospital, First Hospital of China Medical University, The Affiliated Tumor Hospital of Guangxi Medical University, First Affiliated Hospital of Zhejiang University, The Affiliated Hospital of Qingdao University, Guangdong Provincial People's Hospital, Sichuan Cancer Hospital and Research Institute, National Clinical Research Center for Cancer/Cancer Hospital
- Responsible party
- Principal investigator, Zhou Zhiwei, Sun Yat-Sen University Cancer Center
- Investigators
- Zhi-wei Zhou, M.D, Ph.D, Principal investigator, Sun Yat-Sen University Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01815853
- Sponsor's protocol ID
- SYSUCCGPS2
- Acronym
- Neo-CRAG
- Status last verified
- Jun 2025
- First submitted
- 19 Mar 2013
- Last updated
- 3 Jul 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Open-Label, Multicenter, Controlled Phase III Trial Comparing Neoadjuvant Chemoradiotherapy Followed by Surgery and Adjuvant Chemotherapy Versus Neoadjuvant Chemotherapy Followed by Surgery and Adjuvant Chemotherapy in Patients With Locally Advanced Gastric Cancer
- ClinicalTrials.gov ID
- NCT01815853
- Acronym / sponsor ID
- Neo-CRAG / SYSUCCGPS2
- Conditions
- Gastric Cancer
- Keywords
- Neoadjuvant, Chemoradiotherapy, Chemotherapy, Locally advanced gastric cancer, Pathological complete response, D2 gastrectomy
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 620 participants (actual)
- Lead sponsor
- Sun Yat-sen UniversityUniversity, hospital or other
- Collaborators
- The First Affiliated Hospital of Anhui Medical University, Liaoning Cancer Hospital & Institute, Guangdong Provincial Hospital of Traditional Chinese Medicine, Tianjin Medical University Cancer Institute and Hospital, Zhejiang Cancer Hospital, First Hospital of China Medical University, The Affiliated Tumor Hospital of Guangxi Medical University, First Affiliated Hospital of Zhejiang University, The Affiliated Hospital of Qingdao University, Guangdong Provincial People's Hospital, Sichuan Cancer Hospital and Research Institute, National Clinical Research Center for Cancer/Cancer Hospital
- Study start
- Jun 2013 (actual)
- Primary completion
- Jun 2025 (actual)
- Study completion
- Jun 2025 (actual)
- First posted
- 21 Mar 2013 (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.
Patients with histologically confirmed gastric adenocarcinoma with locally advanced gastric cancer are randomized in a 1:1 ratio to receive neoadjuvant chemoradiotherapy with DT45Gy/25f plus three cycles of XELOX therapy or neoadjuvant chemotherapy alone using XELOX regimen following D2 gastrectomy and adjuvant chemotherapy for 3 cycles. The primary end point is 3-year disease free survival (DFS), and secondary end point is 5-year overall survival (OS), R0 resection rate, pathological complete remission (pCR) and treatment safety.
Detailed description
Background: Literatures have shown that patients with locally advanced gastric cancer could potentially benefit from neoadjuvant chemoradiotherapy, but whether this can improve patients' outcome is still unclear.
Patients and methods: In this study , patients with histologically confirmed gastric adenocarcinoma with pre-operative staging are cT3N2/N3M0, cT4aN+M0 and cT4bNanyM0, aged between 18-75 years old, with adequate organ function and having an Eastern Cooperative Oncology Group performance status score ≤2, are randomized in a 1:1 ratio to receive neoadjuvant chemoradiotherapy with DT45Gy/25f plus three cycles of XELOX therapy [Oxaliplatin 130 mg/m² IV on Day 1 + Capecitabine 1000 mg/m² orally BID on Days 1-14 of a 21-day cycle (non-concurrent); Oxaliplatin 100 mg/m² IV on Day 1 + Capecitabine 825 mg/m² orally BID on Days 1-14 of a 21-day cycle (concurrent chemoradiotherapy)] or neoadjuvant chemotherapy alone using XELOX regimen (Oxaliplatin 130 mg/m² IV on Day 1 + Capecitabine 1000 mg/m² orally BID on Days 1-14 of a 21-day cycle) following by D2 gastrectomy and adjuvant chemotherapy with same dosage of XELOX therapy for up to 3 cycles. The primary end point is 3-year disease free survival (DFS), and secondary end point is 5-year overall survival (OS), R0 resection rate, pathological complete remission (pCR) and treatment safety. The final study analytics are to be conducted at the end of the 5th year after the last patient's enrollment.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Neoadjuvant Chemoradiotherapy versus Neoadjuvant Chemotherapy
| Arm | Type | Receives |
|---|---|---|
| Neoadjuvant Chemoradiotherapy | Experimental | Radiation: Neoadjuvant Chemoradiotherapy, Procedure: R0 D2 Gastrectomy, Drug: Adjuvant ChemotherapyRadiotherapy (45Gy/25f) + 3 cycles of XELOX Chemotherapy [Oxaliplatin 130 mg/m² IV on Day 1 + Capecitabine 1000 mg/m² orally BID on Days 1-14 of a 21-day cycle (non-concurrent); Oxaliplatin 100 mg/m² IV on Day 1 + Capecitabine 825 mg/m² orally BID on Days 1-14 of a 21-day cycle (concurrent chemoradiotherapy) ] following with D2 Gastrectomy and 3 cycles of Adjuvant XELOX Chemotherapy |
| Neoadjuvant Chemotherapy | Active comparator | Drug: Neoadjuvant Chemotherapy, Procedure: R0 D2 Gastrectomy, Drug: Adjuvant Chemotherapy3 cycles of XELOX Chemotherapy (Oxaliplatin 130 mg/m² IV on Day 1 + Capecitabine 1000 mg/m² orally BID on Days 1-14 of a 21-day cycle) following with D2 Gastrectomy and 3 cycles of Adjuvant XELOX Chemotherapy |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Histologically confirmed gastric cancer with clinical staging determined by endoscopic ultrasound and contrast-enhanced CT or MRI as cT3N2/N3M0, cT4aN+M0, or cT4bNanyM0.
- Good general condition, with Eastern Cooperative Oncology Group (ECOG) performance status <2 and no contraindications to surgery.
- Ambulatory male or female patients aged 18 to 75 years.
- Sufficient physical fitness and organ function to tolerate major abdominal surgery.
- Baseline laboratory parameters meeting the following criteria: WBC > 4.0 × 10⁹/L, ANC > 1.5 × 10⁹/L, Hb ≥ 100 g/L, PLT ≥ 100 × 10⁹/L, total bilirubin ≤ 1.5 × upper limit of normal (ULN), AST and ALT ≤ 2.5 × ULN, and serum creatinine ≤ 1.0 × ULN.
Key exclusion criteria (15 listed)
- Pregnant or breastfeeding women, or women of childbearing potential not using effective contraception.
- Receipt of any antitumor therapy prior to surgery.
- History of or concurrent malignancies other than gastric cancer.
- Presence of psychiatric disorders, brain metastases, or leptomeningeal metastases.
- Uncontrolled or severe comorbid conditions or active infections.
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 |
|---|---|---|
| Neoadjuvant ChemoradiotherapyRadiotherapy (45Gy/25f) + 3 cycles of XELOX Chemotherapy [Oxaliplatin 130 mg/m² IV on Day 1 + Capecitabine 1000 mg/m² orally BID on Days 1-14 of a 21-day cycle (non-concurrent); Oxaliplatin 100 mg/m² IV on Day 1 + Capecitabine 825 mg/m² orally BID on Days 1-14 of a 21-day cycle (concurrent chemoradiotherapy)] | Radiation | Neoadjuvant Chemoradiotherapy |
| Neoadjuvant Chemotherapy3 cycles of XELOX Chemotherapy (Oxaliplatin 130 mg/m² IV on Day 1 + Capecitabine 1000 mg/m² orally BID on Days 1-14 of a 21-day cycle) | Drug | Neoadjuvant Chemotherapy |
| R0 D2 Gastrectomy | Procedure or surgery | Neoadjuvant Chemoradiotherapy, Neoadjuvant Chemotherapy |
| Adjuvant Chemotherapy3 cycles of XELOX Chemotherapy (Oxaliplatin 130 mg/m² IV on Day 1 + Capecitabine 1000 mg/m² orally BID on Days 1-14 of a 21-day cycle) | Drug | Neoadjuvant Chemoradiotherapy, Neoadjuvant Chemotherapy |
Primary outcome
Disease-free Survival
Time frame: 3 years
3-year DFS
4 secondary outcomes
Overall Survival
Time frame: 5 years
Pathological Complete Remission
Time frame: Peri-operative period
Radical Resection Rate
Time frame: Peri-operative period
Adverse effects
Time frame: Peri-operative period
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 3 Jul 2025.
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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.
Zhi-wei Zhou, M.D, Ph.D principal investigator
Sun Yat-Sen University Cancer Center
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 Neoadjuvant Chemoradiotherapy, Neoadjuvant Chemotherapy and R0 D2 Gastrectomy in people with Gastric Cancer, run by Sun Yat-sen 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?
The sponsor lists 9 inclusion and 15 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 3 Jul 2025. 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?
Disease-free Survival (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 3 Jul 2025.