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

Malignant Neoplasm Other Gallbladder/Extrahepatic Bile Duct Clinical Trial

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02798510
• Other study ID #: FDRT-PG001
• Status: Recruiting
• Phase: Phase 3
• First received: June 9, 2016
• Last updated: June 21, 2016
• Start date: April 2016

Study information

• Verified date: June 2016
• Source: Fudan University
• Contact: zhigang ren, MD
• Phone: 64175590
• Email: zhigang-ren[@]163.com
• Is FDA regulated: No
• Health authority: China: Ethics Committee
• Study type: Interventional

Clinical Trial Summary

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

Description:

The role of adjuvant radiotherapy in gallbladder carcinoma (GBCA) or extrahepatic cholangiocarcinoma (EHCC) is unknown. A retrospective study suggested that chemoradiotherapy provides greater benefit than chemotherapy alone in GBCA patients. SWOG S0809, a phase II study showed that adjuvant chemoradiotherapy has promising efficacy in GBCA or EHCC. The present phase III clinical trial is designed to compare adjuvant concurrent chemoradiotherapy with chemotherapy alone.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 140
• Est. primary completion date: April 2019
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 70 Years

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Cholangiocarcinoma
• Malignant Neoplasm Other Gallbladder/Extrahepatic Bile Duct
• Neoplasms

Intervention

Radiation:
• Concurrent Chemoradiotherapy

Drug:
• capecitabine

• gemcitabine

Locations

Country	Name	City	State
China	Fudan university cancer hospital	Shanghai	Shanghai

Sponsors (1)

Lead Sponsor	Collaborator
Fudan University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	overall survival		24 months	No