NCT01815853CompletedPhase 3
Neoadjuvant Chemoradiotherapy vs. Chemotherapy Followed by Radical Gastrectomy and Adjuvant Chemotherapy for Advanced Gastric Cancer
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
Source: ClinicalTrials.gov · Last updated 3 Jul 2025
Brief summary (registry, in English)
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.
- Status (registry)
- Completed
- Phase (registry)
- Phase 3
- Study type
- Interventional
- Enrollment
- 620 (actual)
- First submitted
- 19 Mar 2013
- Start date
- Jun 2013
- Primary completion date
- Jun 2025
- Lead sponsor
- Sun Yat-sen University
- Diseases
- Gastric and esophageal cancer
- NCT number
- NCT01815853
What you commit to
- Study type: Interventional · Phase 3
- Participants enrolled: 620
- From Jun 2013 to the primary completion date, Jun 2025
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Receipt of any antitumor therapy prior to surgery.
- History of or concurrent malignancies other than gastric cancer.
- Concurrent participation in another clinical trial.
- Contraindications to chemotherapy, radiotherapy, or surgery.
- Ongoing treatment with sorivudine or related analogs.
Other illness
- 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).
- Active hepatitis B or hepatitis C virus infection.
- Chronic intestinal diseases or short bowel syndrome.
- Known hypersensitivity to capecitabine or any of its excipients.
Other
- Pregnant or breastfeeding women, or women of childbearing potential not using effective contraception.
- Grade ≥2 peripheral neuropathy (per NCI-CTCAE).
- Known dihydropyrimidine dehydrogenase (DPD) deficiency.
- Deemed unsuitable for participation in this clinical trial by the investigator.
Who the study is looking for
- 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.
- 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.
Age in the registry: 18 years to 75 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Sun Yat-sen University Cancer Center Coordinator of this site? Confirm its status | Guangzhou | China | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.