Preoperative Stomach Cancer Induction Chemotherapy and Radiation Therapy

Study Overview
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Brief Summary
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Based upon RTOG 9904, this study is to investigate the role of preoperative chemo and chemoradiation for locally advanced gastric cancer.

Official Title
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A Phase III Trial of Preoperative or Postoperative Chemoradiation Therapy for Potentially Resectable Adenocarcinoma of Stomach Cancer

Conditions
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Locally Advanced Gastric Carcinoma

Intervention / Treatment
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* Other: Arm 1 pre-operative chemoradiation
* Other: Arm 2 post operative chemoradiation


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Arm 1 pre-operative chemoradiation<br>Chemo1 x 2 followed by ChemRT followed by Surgery followed by Chemo2 x 2 | Other: Arm 1 pre-operative chemoradiation<br>* 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.<br>|
| Active Comparator: Arm 2 post operative chemoradiation<br>Surgery followed by Chemo1 x 2 followed by ChemRT followed by Chemo2 x 2 | Other: Arm 2 post operative chemoradiation<br>* 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<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Progression Free Survival |  | up to 5 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Overall Survival |  | up to 5 year | 
| R0 Resection Rate |  | At time of surgery |