Gastric Cancer, Neoadjuvant Therapy
Conditions
Keywords
gastric cancer, neoadjuvant chemoradiotherapy, neoadjuvant chemotherapy
Brief summary
This prospective, single arm phase II study is designed to evaluate the rate of pathologic complete response of neoadjuvant chemoradiotherapy and neoadjuvant chemotherapy followed by surgery for locally advanced gastric adenocarcinoma
Interventions
RADIATIONSIB-IMRT
45Gy in 25 fractions using intensity-modulated radiotherapy to the radiation target
DRUGS-1
40-60mg/m2(according to patient's body surface area), orally twice daily every weekday concurrently with radiotherapy treatment
DRUGSOX
SOX (S-1: 40\ 60mg, orally twice daily on days 1 to 14, oxaliplatin 130mg/m2 intravenously on day 1, 21 days per cycle)
PROCEDURESurgery
Surgery, preferred D2 lymphadenectomy
Sponsors
Beijing Hope Run
Jing Jin, M.D.
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
* Histologically or cytologically proven locally advanced gastric adenocarcinoma in patients staged as cT3-4N+M0 * No distant metastasis in liver,lung,bone,central nervous system(CNS),no peritoneal transplantation * No prior abdominal or pelvic radiotherapy * Karnofsky performance status(KPS)≥ 70, predictive life span no less than 6 months * Patients must have normal organ and marrow function as defined below: Leukocytes: greater than or equal to 3,000 G/L; Platelets: greater than or equal to 100,000/mm3 .Hemoglobin:greater than or equal to 10g/L .Total bilirubin: within normal institutional limits; AST/ALT: less than or equal to 1.5 times the upper limit; Creatinine within normal upper limits * Informed consent
Exclusion criteria
* Any prior chemotherapy or other cancer treatment prior to this protocol * Patients with other cancer history except cervical carcinoma in situ and non-malignant melanoma skin cancer * With any distant metastasis in liver,lung,bone,CNS,or peritoneal transplantation * History of allergic reactions attributed to similar chemical or biologic complex to S-1 or Xeloda or Oxaliplatin * Uncontrolled illness including, but not limited to, active infection, symptomatic heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness * History of myocardial infarction within the past 6 months or history of ventricular arrhythmia * History of prior radiation to the abdomen * Pregnant or lactating females
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| PCR rate | 6-8 months | Pathological response were classified into three grades.Grade I signifies that there is little shrinkage in the tumor; only mild regression in the tumor cells is observed under telemicroscope. Grade II shows gross reduction in size of the tumor and marked regression in the cancer cells microscopically, yet viable nests of cancer tissue are still visible. Grade III implies complete or almost total resolution of the tumor on exploration, and disappearance of the tumor tissue microscopically; only remnants of degenerated cancer cells can be seen (so-called ghost cancer cells). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Tumor down-staging | 6-8 months | Down-staging was considered as any stage reduction between clinical and pathologic stage. |
| R0 resection rate | 6-8 months | The surgical procedure was total or subtotal gastrectomy with recommended D2 lymphadenectomy 4-6 weeks after total neoadjuvant therapy. |
| Acute chemotherapy/Chemoradiotherapy toxicities | 6-8 months | chemotherapy toxicities are evaluated by NCI-CTC version 4.0 and radiotherapy toxicities are graded using the RTOG/EORTC Radiation Morbidity Scoring Schema. |
| surgery complications | 6-8 months | During hospital stay and within the first 30 days after completion of surgery. |
Countries
China
Contacts
Primary ContactJing Jin, MD
Outcome results
None listed