Gastric Cancer
Conditions
Keywords
gastric cancer, adjuvant chemo-radiotherapy
Brief summary
The purpose of this study is to explore the role of adjuvant chemo-radiotherapy in patients with local advanced gastric cancer.
Interventions
RADIATIONAdjuvant Concurrent Chemo-radiotherapy
Adjuvant concurrent chemo-radiotherapy will be given to the patients in the Experimental group after 4-6 cycles of SOX chemotherapy. Total dose of 45Gy is delivered by IMRT Radiotherapy technique. The concurrent chemotherapy regimen is as follow: S-1 40-60mg Bid, Oral.
DRUGAdjuvant chemotherapy for active comparator group
8 cycles of SOX adjuvant chemotherapy will be given to the patients in the active comparator group. The SOX chemotherapy regimen is as follow: S-1 40-60mg Bid, Oral, D1-14, Q21D; Oxaliplatin 130mg/m2, ivgtt, D1, Q21d.
DRUGAdjuvant chemotherapy for experimental group
6 cycles of SOX adjuvant chemotherapy will be given to the patients in the experimental group. The SOX chemotherapy regimen is as follow: S-1 40-60mg Bid, Oral, D1-14, Q21D; Oxaliplatin 130mg/m2, ivgtt, D1, Q21d.
Sponsors
Chinese Academy of Medical Sciences
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Disease-free survival | 3 years |
Secondary
| Measure | Time frame |
|---|---|
| Local recurrence free survival | 3 years |
| Distant metastasis free survival | 3 years |
| Over all survival | 3 years |
| Adverse Event | 3 years |
Countries
China
Contacts
Primary ContactNing Li
Outcome results
None listed