Chemoradiation, Gastric Cancer
Conditions
Keywords
Gastric cancer, Chemo-radiotherapy, Phase I study, Hypo-fractionated radiotherapy
Brief summary
Gastric cancer is one of the most common malignant tumors in China, and the incidence and mortality rate are second in malignant tumors. The treatment of gastric cancer need integrated multidisciplinary treatment, and surgery is the only possible curative method for gastric cancer at present. Previous studies have reported that neoadjuvant chemoradiotherapy can downstage primary tumor to increase radical resection rate in order to improve the long-term prognosis of advanced gastric cancer. However, there is no study on the application of hypo-radiotherapy to neoadjuvant radiotherapy in gastric cancer. The aim of this study was to observe the maximum tolerated dose (MTD) and dose limited toxicity (DLT) of hypo-fractionated radiotherapy for locally advanced gastric cancer.
Detailed description
After enrolled in this study, the patient was first treated with radiotherapy, concurrent with oral S-1 80mg/m2/day, on radiotherapy days. 3 weeks after the end of radiotherapy, patients treated with neoadjuvant chemotherapy with oxaliplatin and S-1. Oxaliplatin is given on dose of 130mg/m2 iv on day 1; S-1 on 40-60mg po BID on day 1-14, oral. Imaging evaluation was performed 3 weeks after neoadjuvant treatment. The radical operation and surgical procedure were determined on MDT discussion. Non-operable patients continue with 3 cycles of chemotherapy, and the chemotherapy regimen can be changed. A 3 cycle of SOX adjuvant chemotherapy was performed after surgery.
Interventions
RADIATIONHypo-fractionated radiotherapy
Hypo-fractionated radiotherapy with fraction \>2Gy .
DRUGS1
S-1 80mg/m2/day, orally intake on radiotherapy days.
Sponsors
Chinese Academy of Medical Sciences
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
* Clinical stage T3-4N+M0 * Gastric cancer or Siewert II/III esophagogastric junction carcinoma; * Pathologically confirmed adenocarcinoma; * 18-75 years old, male or female; * Karnofsky score \>= 70; * White blood cell count \>= 4 x 109 / L; platelet count \>= 100 x109/L; serum creatinine =\< 1 x upper limit of normal, total bilirubin =\< 1 x upper limit of normal, alanine aminotransferase and aspartate aminotransferase =\< 2.5 x upper limit of normal, alkaline phosphatase =\< 5 x upper limit of normal.
Exclusion criteria
* Any chemotherapy or radiotherapy history before enrollment * Siewert I EGJ cancer
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Maximum tolerated dose AND Dose limited toxicity | From date of enrollment until one month after chemo-radiotherapy | To assess maximum tolerated dose and dose limited toxicity of hypo-fractionated neoadjuvant radiotherapy |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Response rate | From date of enrollment until surgery, assessed up to 2 months | To evaluate the pathological response rate of gastric cancer after hypo-fractionated neoadjuvant radiotherapy |
| 2-year disease-free survival | From date of enrollment until the date of first documented progression or date of relapse, whichever came first, assessed up to 24 months | To evaluate the 2-year disease-free survival of gastric cancer after hypo-fractionated neoadjuvant radiotherapy |
Countries
China
Contacts
Primary ContactJing Jin, MD
Backup ContactNing Li, MD
Outcome results
None listed