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

Primary Purpose

Malignant Neoplasm Other Gallbladder/Extrahepatic Bile Duct

Status

Unknown status

Phase

Phase 3

Locations

China

Study Type

Interventional

Intervention

Concurrent Chemoradiotherapy

capecitabine

gemcitabine

About this trial

This is an interventional treatment trial for Malignant Neoplasm Other Gallbladder/Extrahepatic Bile Duct focused on measuring Gallbladder Carcinoma, Extrahepatic Cholangiocarcinoma, Chemoradiotherapy

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

Fudan university cancer hospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Arm 1

Arm 2

Arm Description

Patients in arm 1 will receive adjuvant chemotherapy followed by concurrent chemoradiotherapy. Patients will receive four cycles of gemcitabine (1,000mg/m2 intravenously on days 1 and 8) and capecitabine (1,500mg/m2 per day on days 1 to 14) every 21 days followed by concurrent capecitabine (1,330mg/m2 per day) and radiotherapy (50.4Gy/28fx to regional lymphatics with or without tumor bed)

Patients in arm 2 will receive six cycles chemotherapy of gemcitabine (1,000mg/m2 intravenously on days 1 and 8) and capecitabine (1,500mg/m2 per day on days 1 to 14) every 21 days

Outcomes

Primary Outcome Measures

overall survival

Secondary Outcome Measures

Full Information

NCT ID

NCT02798510

First Posted

June 9, 2016

Last Updated

June 21, 2016

Sponsor

Fudan University

1. Study Identification

Unique Protocol Identification Number

NCT02798510

Brief Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

June 2016

Overall Recruitment Status

Unknown status

Study Start Date

April 2016 (undefined)

Primary Completion Date

April 2019 (Anticipated)

Study Completion Date

undefined (undefined)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Fudan University

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

Brief Summary

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

Detailed 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Malignant Neoplasm Other Gallbladder/Extrahepatic Bile Duct

Keywords

Gallbladder Carcinoma, Extrahepatic Cholangiocarcinoma, Chemoradiotherapy

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 3

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

140 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Arm 1

Arm Type

Experimental

Arm Description

Arm Title

Arm 2

Arm Type

Active Comparator

Arm Description

Patients in arm 2 will receive six cycles chemotherapy of gemcitabine (1,000mg/m2 intravenously on days 1 and 8) and capecitabine (1,500mg/m2 per day on days 1 to 14) every 21 days

Intervention Type

Radiation

Intervention Name(s)

Concurrent Chemoradiotherapy

Intervention Type

Drug

Intervention Name(s)

capecitabine

Intervention Type

Drug

Intervention Name(s)

gemcitabine

Primary Outcome Measure Information:

Title

overall survival

Time Frame

24 months

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

70 Years

Accepts Healthy Volunteers

Eligibility 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.

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

zhigang ren, MD

Phone

64175590

Ext

8627

zhigang-ren@163.com

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

zhigang ren, MD

Organizational Affiliation

Fudan University

Official's Role

Principal Investigator

Facility Information:

Facility Name

Fudan university cancer hospital

City

Shanghai

State/Province

Shanghai

ZIP/Postal Code

200032

Country

China

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

zhigang ren, MD

Phone

64175590

Ext

8627

zhigang-ren@163.com

12. IPD Sharing Statement

Citations:

PubMed Identifier

34515993

Citation

Luvira V, Satitkarnmanee E, Pugkhem A, Kietpeerakool C, Lumbiganon P, Pattanittum P. Postoperative adjuvant chemotherapy for resectable cholangiocarcinoma. Cochrane Database Syst Rev. 2021 Sep 13;9(9):CD012814. doi: 10.1002/14651858.CD012814.pub2.

Results Reference

derived

Learn more about this trial

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

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