A Randomized Phase III Study of Adjuvant Chemotherapy With or Without Chemo-radiotherapy in Patients With Local Advanced Gastric Cancer After D2 Resection.
Overview
- Phase
- Phase 3
- Intervention
- Adjuvant chemotherapy for active comparator group
- Conditions
- Gastric Cancer
- Sponsor
- Chinese Academy of Medical Sciences
- Enrollment
- 588
- Locations
- 1
- Primary Endpoint
- Disease-free survival
- Last Updated
- 10 years ago
Overview
Brief Summary
The purpose of this study is to explore the role of adjuvant chemo-radiotherapy in patients with local advanced gastric cancer.
Investigators
Jing Jin, M.D.
M.D.
Chinese Academy of Medical Sciences
Eligibility 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.
Arms & Interventions
Adjuvant Chemotherapy
The interventions of adjuvant chemotherapy group is 8 cycles of SOX(S-1+Oxaliplatin) chemotherapy to be given. The SOX chemotherapy regimen is as follow: S-1 40-60mg Bid, Oral, D1-14, Q21D; Oxaliplatin 130mg/m2, ivgtt, D1, Q21d.
Intervention: Adjuvant chemotherapy for active comparator group
Adjuvant Chemo-radiotherapy
The interventions of adjuvant chemo-radiotherapy group is concurrent chemo-radiotherapy to be give after 4-6 cycles of chemotherapy. Total dose of 45Gy is delivered by IMRT Radiotherapy technique. The concurrent chemotherapy regimen is as follow: S-1 40-60mg Bid, Oral. Six cycles of SOX chemotherapy to be given. The SOX chemotherapy regimen is as follow: S-1 40-60mg Bid, Oral, D1-14, Q21D; Oxaliplatin 130mg/m2, ivgtt, D1, Q21d.
Intervention: Adjuvant Concurrent Chemo-radiotherapy
Adjuvant Chemo-radiotherapy
The interventions of adjuvant chemo-radiotherapy group is concurrent chemo-radiotherapy to be give after 4-6 cycles of chemotherapy. Total dose of 45Gy is delivered by IMRT Radiotherapy technique. The concurrent chemotherapy regimen is as follow: S-1 40-60mg Bid, Oral. Six cycles of SOX chemotherapy to be given. The SOX chemotherapy regimen is as follow: S-1 40-60mg Bid, Oral, D1-14, Q21D; Oxaliplatin 130mg/m2, ivgtt, D1, Q21d.
Intervention: Adjuvant chemotherapy for experimental group
Outcomes
Primary Outcomes
Disease-free survival
Time Frame: 3 years
Secondary Outcomes
- Over all survival(3 years)
- Local recurrence free survival(3 years)
- Distant metastasis free survival(3 years)
- Adverse Event(3 years)