Neoadjuvant Chemoradiotherapy vs. Chemotherapy Followed by Radical Gastrectomy and Adjuvant Chemotherapy for Advanced Gastric Cancer

NCT01815853 | Completed Phase 3 DMC

• 1 other identifier: SYSUCCGPS2
• Study Type: interventional
• Target: 620
• Locations: 1 country
• Sites: 1

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 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.

Conditions

Gastric Cancer

Keywords

Neoadjuvant; Chemoradiotherapy; Chemotherapy; Locally advanced gastric cancer; Pathological complete response; D2 gastrectomy

Outcome Measures

Primary Outcomes (1)

• Disease-free Survival

  3-year DFS

  3 years

Secondary Outcomes (4)

• Overall Survival

  5 years

• Pathological Complete Remission

  Peri-operative period

• Radical Resection Rate

  Peri-operative period

• Adverse effects

  Peri-operative period

Study Arms (2)

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

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

Drug: Neoadjuvant Chemotherapy; Procedure: R0 D2 Gastrectomy; Drug: Adjuvant Chemotherapy

Interventions

Neoadjuvant Chemoradiotherapy RADIATION

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 Chemoradiotherapy

Neoadjuvant Chemotherapy DRUG

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)

Neoadjuvant Chemotherapy

R0 D2 Gastrectomy PROCEDURE

Neoadjuvant Chemoradiotherapy; Neoadjuvant Chemotherapy

Adjuvant Chemotherapy DRUG

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)

Neoadjuvant Chemoradiotherapy; Neoadjuvant Chemotherapy

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Sun Yat-sen University: lead
• The First Affiliated Hospital of Anhui Medical University: collaborator
• Liaoning Cancer Hospital & Institute: collaborator
• Guangdong Provincial Hospital of Traditional Chinese Medicine: collaborator
• Tianjin Medical University Cancer Institute and Hospital: collaborator
• Zhejiang Cancer Hospital: collaborator
• First Hospital of China Medical University: collaborator
• The Affiliated Tumor Hospital of Guangxi Medical University: collaborator
• Hangzhou First People's Hospital, School of Medicine, Zhejiang Universiry: collaborator
• The Affiliated Hospital of Qingdao University: collaborator
• Guangdong Provincial People's Hospital: collaborator
• Sichuan Cancer Hospital and Research Institute: collaborator
• National Clinical Research Center for Cancer/Cancer Hospital: collaborator

Study Sites (1)

Sun Yat-sen University Cancer Center

Guangzhou, Guangdong, 510060, China

Location

MeSH Terms

Conditions

Stomach Neoplasms

Interventions

Neoadjuvant Therapy; Chemotherapy, Adjuvant

Condition Hierarchy (Ancestors)

Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Stomach Diseases

Intervention Hierarchy (Ancestors)

Combined Modality Therapy; Therapeutics; Drug Therapy

Study Officials

• Zhi-wei Zhou, M.D, Ph.D

  Sun Yat-sen University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director of Gastric Surgery

Model Details: Neoadjuvant Chemoradiotherapy versus Neoadjuvant Chemotherapy

Study Record Dates

• First Submitted: March 19, 2013
• First Posted: March 21, 2013
• Study Start: June 1, 2013
• Primary Completion: June 1, 2025
• Study Completion: June 1, 2025
• Last Updated: July 3, 2025

Record last verified: 2025-06

Locations

CN (1)