Trial of Adjuvant Chemotherapy for High Risk Gastric Cancer Patients

• Status: Unknown status
• Trial end date: 2016-12-01
• Target enrollment: 0
• Participant gender: All

Summary

This trial is going to evaluate the efficacy and safety of two regimens of DX (docetaxel plus capecitabine)and XELOX (oxaliplatin plus capecitabine)as adjuvant chemotherapy for stage IIIb-IIIc gastric cancer patients after curative D2/D2+ operation, and to investigate the optimal adjuvant regimen for such extremely high risk patients.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Tianjin Medical University Cancer Institute and Hospital
• Treatments: Capecitabine; Docetaxel

Criteria

Inclusion Criteria:

• a post operation histologically confirmed gastric or esophagogastric junction adenocarcinoma;

• curative D2 or D2+ operation had been performed, and the pathological stage post operation was verified as IIIb or IIIc;

• no adjuvant chemotherapy before or after operation;

• Karnofsky performance status scale ≥ 70;

• prior adjuvant chemotherapy that did not include taxanes and S-1;

• white blood count ≥ 3,500/mm3, absolute neutrophil count ≥ 1,500/mm3, platelet count ≥ 100,000/mm3, hemoglobin count ≥ 90 g/dL, serum bilirubin level < 1.5 of the upper limit of normal (ULN) for the institution, aspartate aminotransferase, alanine aminotransferase and alkaline phosphatase ≤ 2.5 ULN, serum albumin ≥ 30g/L, serum creatinine ≤ 1.5 ULN; and

• normal cardiac function with no severe heart disease.

Exclusion Criteria:

Major exclusion criteria were as follows:

• pregnancy or breast feeding;

• past history of allergy to taxanes, platinum and 5-fluorouracil or their analogues;

• radiotherapy for all measurable target lesions;

• obstructive bowel disease;

• past history of other cancers except for cured non-melanoma skin cancer or cervical cancer; and

• concomitant treatment with other anticancer drugs.