Status:
COMPLETED
Neoadjuvant Chemoradiotherapy vs. Chemotherapy Followed by Radical Gastrectomy and Adjuvant Chemotherapy for Advanced Gastric Cancer
Lead Sponsor:
Sun Yat-sen University
Collaborating Sponsors:
The First Affiliated Hospital of Anhui Medical University
Liaoning Cancer Hospital & Institute
Conditions:
Gastric Cancer
Eligibility:
All Genders
18-75 years
Phase:
PHASE3
Brief 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 cyc...
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 st...
Eligibility Criteria
Inclusion
- 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.
Exclusion
- 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).
- 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.
Key Trial Info
Start Date :
June 1 2013
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 1 2025
Estimated Enrollment :
620 Patients enrolled
Trial Details
Trial ID
NCT01815853
Start Date
June 1 2013
End Date
June 1 2025
Last Update
July 3 2025
Active Locations (1)
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1
Sun Yat-sen University Cancer Center
Guangzhou, Guangdong, China, 510060