A Randomized Phase III Study of Adjuvant Chemotherapy With or Without Chemo-radiotherapy in Patients With Local Advanced Gastric Cancer After D2 Resection.

• Status: Recruiting
• Trial end date: 2022-06-01
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this study is to explore the role of adjuvant chemo-radiotherapy in patients with local advanced gastric cancer.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Chinese Academy of Medical Sciences
• Treatments: Oxaliplatin

Criteria

Inclusion Criteria:

• Gastric cancer;

• D2 and R0 resection;

• Pathologically confirmed stage anyT, N+, M0 (AJCC Cancer Staging);

• Karnofsky performance score (KPS) >= 70 or Eastern Cooperative Oncology Group(ECOG) score 0-1;

• Adequate blood counts: White blood cell count ≥3.5 x 109/L Haemoglobin levels ≥100g/L Platelet count ≥100 x 109/L Creatinine levels ≤1.0× upper normal limit（UNL） Urea nitrogen levels ≤1.0× upper normal limit（UNL） Alanine aminotransferase(ALT) ≤1.5× upper normal limit（UNL） Aspartate aminotransferase(AST) ≤1.5× upper normal limit（UNL） Alkaline phosphatase(ALP) ≤1.5× upper normal limit（UNL） Total bilirubin(TBIL) ≤1.5× upper normal limit（UNL）

• No allergic history of 5-Fu or Platinum drugs;

• No history of chemotherapy or other anti-cancer therapy;

• Informed consent should be signed.

Exclusion Criteria:

• GEJ adenocarcinoma

• Concomitant malignancies;(except basocellular carcinoma or in-situ cervical carcinoma)

• Allergic to Fluorouracil or Platinum drugs;

• Concurrent uncontrolled medical condition;

• Known malabsorption syndromes or lack of physical integrity of upper gastrointestinal tract;

• Severe postoperative complications such as anastomotic leakage, etc.;

• Symptoms or history of peripheral neuropathy.