Locally Advanced Gastric Carcinoma
Conditions
Brief summary
Based upon RTOG 9904, this study is to investigate the role of preoperative chemo and chemoradiation for locally advanced gastric cancer.
Interventions
OTHERArm 1 pre-operative chemoradiation
Chemotherapy 1: First 2 courses of chemotherapy with the Capacitabine /cisplatin/ combination.Capacitabine1 g/me2 day 1 to 14. Cisplatin will be given at 20 mg/m2 as a one-hour bolus on day1-5. Chemoradiotherapy: At the end of the second 21 days of chemotherapy and one week of rest (day 57), a total of 45 Gy(1.8 Gyfx/d) of radiotherapy will be given with concurrent capacitabine 625 mg/m2 and weekly Taxol 45mg/m2 over 3 hours for 5 weeks. Chemotherapy2: Four to five weeks after chemoradiotherapy, Restaged and surgical resection, a D2 resection is encouraged. Peritoneal cytology will be obtained. The J-tube will be left in for at least 8 weeks after surgery to supplement patient's nutrition. 2nd courses of chemotherapy with the Capacitabine. Capacitabine1 g/me2 day 1 to 14. Chemotherapy will be repeated beginning on Day 29.
OTHERArm 2 post operative chemoradiation
Surgical resection, a D2 resection is encouraged. Chemotherapy 1: All patients will first receive two courses of chemotherapy with the Capacitabin /cisplatin/ combination.Capacitabine1 g/me2 day 1 to 14. Cisplatin will be given at 20 mg/m2 as a bolus on day1-5. Chemotherapywill be repeated beginning on Day 22. Chemoradiotherapy: At the end of the second 21 days of chemotherapy and one week of rest (day 57), a total of 45 Gy(1.8 Gyfx/d) of radiotherapy will be given with concurrent capacitabine 625 mg/m2 and weekly Taxol 45mg/m2 over 3 hours for 5 weeks. Chemotherapy2: 2nd courses of chemotherapy with the Capacitabin. Capacitabine 1g/me2 day 1 to 14. Chemotherapy will be repeated beginning on Day 29
Sponsors
Xijing Hospital
Sichuan Provincial People's Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
* Patients with potentially resectable adenocarcinoma of the stomach with histologic proof. * EUS or MRI stage T3-4, any N, M0. * Adequate bone marrow (defined as peripheral absolute granulocyte count of \> 2,000/μL, and platelet count of\>100,000/μL), liver (bilirubin \< 1.5 mg/dl), and renal functions (creatinine \< 1.5 mg/dl). * Absence of peritoneal disease by laparoscopic staging; no positive cytology of pleural, or pericardial effusion. * No prior major surgery or radiotherapy to the stomach, or immunotherapy or chemotherapy for any reason. * Patients must have a life expectancy of at least 16 weeks. * Performance status of \< 2 (Zubrod scale). * No biopsy proof of lymph node metastases outside the study field. * No evidence of metastatic disease to distant organs. * No presence of concurrent or previous malignancies \< 5 years, other than noninvasive skin cancer. * No uncontrolled or severe cardiac disease, diabetes or hypertension. * Signed study-specific consent form prior to study entry.
Exclusion criteria
* Evidence of metastatic disease * Prior chemotherapy or radiotherapy * Patients with a past history of cancer * Patients with other significant underlying medical conditions that may be aggravated by the study treatment or are not controlled * Pregnant or lactating females or female patients of childbearing potential who have not been surgically sterilized or are without adequate contraceptive measures * Cardiac failure or Sever Pulmonary disease * Patients with impaired gastrointestinal absorption for whatever reason * Patients medically unfit for cisplatin or taxol chemotherapy
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Progression Free Survival | up to 5 year |
Secondary
| Measure | Time frame |
|---|---|
| Overall Survival | up to 5 year |
| R0 Resection Rate | At time of surgery |
Countries
China
Contacts
Primary ContactQian Peng, MD PhD
Outcome results
None listed