Docetaxel-based Chemoradiotherapy Plus Periradiation Chemotherapy Compared With INT 0116 Adjuvant Arm in Gastric Cancer

Although the intergroup 0116 trial was the first to demonstrate that adjuvant chemoradiotherapy offers a significant survival benefit in completely resected gastric cancer,it is more toxic and less effective. It is reasonable to optimize this regimen.

Sex

All

Minimum age

20 Years

Maximum age

75 Years

Inclusion Criteria:

* Patients with microscopically confirmed stages IB through IIIB adenocarcinoma of the stomach or gastroesophageal junction, who underwent a potentially curative resection (ie, R0 resection);
* Zubrod performance status 0 to 1;
* No prior chemotherapy or prior radiation therapy to the treatment field;
* Age 20-75;
* Absolute granulocyte count (AGC) ≥2 × 109 cells/L, platelets ≥ 100× 109 cells/L, hemoglobin ≥ 10.0 g/dl (Note: The use of transfusion or other intervention to achieve Hgb ≥ 10.0 g/dl is acceptable)
* Adequate renal and hepatic function (serum creatinine ≤1.5 × upper limit of normal \[ULN\], bilirubin and AST ≤1.5 × ULN).

Exclusion Criteria:

* A history of prior upper abdominal radiotherapy or chemotherapy;
* Evidence of metastatic disease to distant organs, peritoneal carcinoma by computed tomography or positive cytology of peritoneal effusion;
* Prior malignancies (except cured cervical carcinoma in situ, non-melanoma skin cancer, or other curatively treated cancer with no evidence of disease for ≥5 years);
* active inflammatory bowel disease;
* Unstable angina and/or congestive heart failure requiring hospitalization within the last 6 months;
* Transmural myocardial infarction within the last 6 months;
* uncontrolled hypertension;
* Chronic Obstructive Pulmonary Disease(COPD) exacerbation or other respiratory illness requiring hospitalization or precluding study therapy within 60 days before registration;
* Hepatic insufficiency resulting in clinical jaundice and/or coagulation defects;
* Patients with Acquired Immune Deficiency Syndrome were excluded from the study because the treatments involved in this protocol may be significantly immunosuppressive.
* Hypersensitivity reaction to docetaxel;
* Uncontrolled neuropathy grade 2 or greater regardless of cause;
* Conditions precluding medical follow-up and protocol compliance;
* Pregnant or lactating women are excluded from study entry due to the embryotoxic effects of the protocol treatment.

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