Clinical Trial of Adjuvant Chemotherapy Followed by Concurrent Chemoradiotherapy Compared With Adjuvant Chemotherapy Alone in Patients With Gallbladder Carcinoma and Extrahepatic Cholangiocarcinoma

• Status: Unknown status
• Trial end date: 1969-12-31
• Target enrollment: 0
• Participant gender: All

Summary

The present study is designed to determine whether adjuvant concurrent chemoradiotherapy improves overall survivals.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Fudan University
• Treatments: Capecitabine; Gemcitabine

Criteria

Inclusion Criteria:

• The patients with pathologic diagnosis of gallbladder carcinoma (GBCA) or extrahepatic cholangiocarcinoma (EHCC) after radical resection.

• The patients with pathologic stage T2-4 or N1 in R0 resection or positive resection margins (R1).

• Aged 18 to 70 years old, male or female, body condition score generally ECOG 0～2, expected survival ≥ 6 months.

• Subjects were no major organ dysfunction, blood, liver, kidney and heart function was normal, the specific requirements of laboratory indicators:

• Blood: Absolute neutrophil count > 1.5 × 109 / L, Platelet count > 100 × 109 / L, Hb > 8.0g/dl.

• Liver function: serum bilirubin less than 1.5 times the upper limit of normal; ALT and AST less than 2.5 times the upper limit of normal.

• Renal function: creatinine less than 1.5 times the upper limit of normal.

• Patients who can understand the circumstances of this study and signed informed consent.

Exclusion Criteria:

• Pregnancy, breast-feeding patients；

• Patients received prior anticancer therapy for the current malignancy or upper abdominal radiotherapy or chemotherapy at any time.

• Patients with malignant ascites.

• Patients with purulent and chronic infected wounds which delayed healing.

• Patients with liver, kidney and heart failure and coronary heart disease, angina, myocardial infarction, arrhythmia, cerebral thrombosis, stroke and other serious cardiovascular and cerebrovascular disease;

• Patients has a history of mental illness and difficult to control;

• Patients who was considered inappropriate to participate in the trials by the researchers.