Back to results

Adjuvant Chemotherapy for Biliary Tract Cancer After Curative Resection (AdBTC-1)

Primary Purpose

Cholangiocarcinoma, Gall Bladder Carcinoma

Status

Recruiting

Phase

Phase 3

Locations

China

Study Type

Interventional

Intervention

Gemcitabine

Capecitabine

About this trial

This is an interventional treatment trial for Cholangiocarcinoma focused on measuring adjuvant chemotherapy, cholangiocarcinoma, invasive gall bladder carcinoma, overall survival, disease free survival, Gemcitabine, Capecitabine

Eligibility Criteria

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

DISEASE CHARACTERISTICS:

Histologically confirmed biliary tract cancer (including intrahepatic, extrahepatic, hilar cholangiocarcinoma or muscle invasive gallbladder cancer or cancer of the distal bile duct)
Must have undergone a radical surgical approach which includes liver resection, pancreatic resection, or less commonly both
Patients with pathological evidence of microscopic involvement of the margins of the excised specimen are eligible as long as resection is macroscopically complete
Must be able to start treatment within 12 weeks of surgery
No pancreatic or periampullary cancer
No mucosal gallbladder cancer

PATIENT CHARACTERISTICS:

ECOG performance status 0-2
Urea < 1.5 times upper limit of normal (ULN)
Creatinine < 1.5 times ULN
Glomerular filtration rate ≥ 60 mL/min (if < 60 mL/min, adequate renal function for capecitabine must be confirmed by isotope EDTA)
Hemoglobin ≥ 10 g/dL
WBC ≥ 3,000/mm³
Absolute neutrophil count ≥ 1,500/mm³
Platelet count ≥ 100,000/mm³
Bilirubin ≤ 3 times ULN
ALT and AST ≤ 5 times ULN
Adequate surgical biliary drainage with no evidence of infection
Not pregnant or nursing
Negative pregnancy test for women of childbearing age and childbearing potential
Fertile patients must use effective contraception during study treatment and for at least 3 months after study treatment has ended
Must provide written informed consent
No history of other malignant diseases within the past 5 years
No serious coexisting medical condition likely to interfere with protocol treatment, including a potential serious infection
No evidence of significant clinical disorder or laboratory finding that makes it undesirable for the patient to participate in the trial
No psychological, familial, sociological, or geographical factors considered likely to preclude study compliance
No other serious uncontrolled medical conditions
No unresolved biliary tree obstruction

PRIOR CONCURRENT THERAPY:

See Disease Characteristics
Completely recovered from prior surgery
No use of other investigational agents within 28 days prior to and during study treatment
No prior chemotherapy or radiotherapy for biliary tract cancer
No other concurrent anticancer chemotherapy, radiotherapy, or investigational agent

Sites / Locations

Tianjin Medical University Cancer Insititute and HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Gemcitabine plus Capecitabine

Capecitabine

Arm Description

Gemcitabine (1000 mg per square meter) on days 1 and 8 Capecitabine (1250 mg per square meter) twice a day on days 1-14. Treatment repeats every 3 weeks for 8 courses in the absence of disease progression or unacceptable toxicity.

Capecitabine (1250 mg per square meter) twice a day on days 1-14. Treatment repeats every 3 weeks for 8 courses in the absence of disease progression or unacceptable toxicity.

Outcomes

Primary Outcome Measures

Disease free survival (DFS) rate

DFS

Secondary Outcome Measures

Overall survival (OS) rate

Disease free survival (DFS) rate

DFS

Overall survival (OS) rate

The rate of patients with hepatic or locoregional recurrence

Full Information

NCT ID

NCT03779035

First Posted

December 12, 2018

Last Updated

December 17, 2018

Sponsor

Tianjin Medical University Cancer Institute and Hospital

1. Study Identification

Unique Protocol Identification Number

NCT03779035

Brief Title

Adjuvant Chemotherapy for Biliary Tract Cancer After Curative Resection

Acronym

AdBTC-1

Official Title

Adjuvant Chemotherapy With Gemcitabine and Capecitabine Compared to Capecitabine for Biliary Tract Cancer After Curative Resection

Study Type

Interventional

2. Study Status

Record Verification Date

December 2018

Overall Recruitment Status

Recruiting

Study Start Date

December 15, 2018 (Anticipated)

Primary Completion Date

December 31, 2020 (Anticipated)

Study Completion Date

December 31, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Tianjin Medical University Cancer Institute and Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Product Manufactured in and Exported from the U.S.

5. Study Description

Brief Summary

This prospective, open-Label, comparative, randomized, controlled phase III trial was designed to compare the clinical performance of gemcitabine with capecitabine vs. capecitabine alone for patients with biliary tract cancer (BTC) after curative resection.

Detailed Description

Currently, complete surgical resection represents the only potentially curative treatment option for cholangiocarcinoma (CCA, including intrahepatic, hilar and distal CCA) and gallbladder carcinoma (GBCA). Because of high rates of disease recurrence and poor survival rates following surgical resection, postoperative treatment have been considered to improve patient survival after resection of BTC. The systematic review showed a beneficial impact of adjuvant treatment in BTC, particularly in patients with involved lymph nodes or resection margins and distal or hilar CCA. However, in regard of the paucity of randomized data, current guidelines recommend inclusion in clinical trials. Previously, the data of the BILCAP trial showed an improvement in median overall survival for capecitabine compared to observation alone for BTC, indicating capecitabine as the new standard postoperative treatment after curative resection of BTC. Previous phase II studies for advanced BTC showed superiority of the combination gemcitabine/ capecitabine regimen vs. the capecitabine monotherapy, the median OS was 12.7-14 vs. 7.9 months. Based on these data, this AdBTC trial will was designed to compare the clinical performance of gemcitabine with capecitabine vs. capecitabine alone for patients with biliary tract cancer (BTC) after curative resection, aiming for superiority of the combination regimen vs. the oral monotherapy. This will be based on the BILCAP protocol, applying the similar dosing, assessments and dose modifications. The primary endpoint is DFS and secondary endpoints include recurrence free survival, OS, safety and tolerability of adjuvant CTx, quality of life, and patterns of disease recurrence.

6. Conditions and Keywords

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

Cholangiocarcinoma, Gall Bladder Carcinoma

Keywords

adjuvant chemotherapy, cholangiocarcinoma, invasive gall bladder carcinoma, overall survival, disease free survival, Gemcitabine, Capecitabine

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 3

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

460 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Gemcitabine plus Capecitabine

Arm Type

Experimental

Arm Description

Arm Title

Capecitabine

Arm Type

Active Comparator

Arm Description

Capecitabine (1250 mg per square meter) twice a day on days 1-14. Treatment repeats every 3 weeks for 8 courses in the absence of disease progression or unacceptable toxicity.

Intervention Type

Drug

Intervention Name(s)

Gemcitabine

Intervention Description

1000mg/m2

Intervention Type

Drug

Intervention Name(s)

Capecitabine

Intervention Description

1250mg/m2

Primary Outcome Measure Information:

Title

Disease free survival (DFS) rate

Description

DFS

Time Frame

at 24 months

Secondary Outcome Measure Information:

Title

Overall survival (OS) rate

Description

Time Frame

at 24 months

Title

Disease free survival (DFS) rate

Description

DFS

Time Frame

at 60 months

Title

Overall survival (OS) rate

Description

Time Frame

at 60 months

Title

The rate of patients with hepatic or locoregional recurrence

Time Frame

24 months

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

DISEASE CHARACTERISTICS: Histologically confirmed biliary tract cancer (including intrahepatic, extrahepatic, hilar cholangiocarcinoma or muscle invasive gallbladder cancer or cancer of the distal bile duct) Must have undergone a radical surgical approach which includes liver resection, pancreatic resection, or less commonly both Patients with pathological evidence of microscopic involvement of the margins of the excised specimen are eligible as long as resection is macroscopically complete Must be able to start treatment within 12 weeks of surgery No pancreatic or periampullary cancer No mucosal gallbladder cancer PATIENT CHARACTERISTICS: ECOG performance status 0-2 Urea < 1.5 times upper limit of normal (ULN) Creatinine < 1.5 times ULN Glomerular filtration rate ≥ 60 mL/min (if < 60 mL/min, adequate renal function for capecitabine must be confirmed by isotope EDTA) Hemoglobin ≥ 10 g/dL WBC ≥ 3,000/mm³ Absolute neutrophil count ≥ 1,500/mm³ Platelet count ≥ 100,000/mm³ Bilirubin ≤ 3 times ULN ALT and AST ≤ 5 times ULN Adequate surgical biliary drainage with no evidence of infection Not pregnant or nursing Negative pregnancy test for women of childbearing age and childbearing potential Fertile patients must use effective contraception during study treatment and for at least 3 months after study treatment has ended Must provide written informed consent No history of other malignant diseases within the past 5 years No serious coexisting medical condition likely to interfere with protocol treatment, including a potential serious infection No evidence of significant clinical disorder or laboratory finding that makes it undesirable for the patient to participate in the trial No psychological, familial, sociological, or geographical factors considered likely to preclude study compliance No other serious uncontrolled medical conditions No unresolved biliary tree obstruction PRIOR CONCURRENT THERAPY: See Disease Characteristics Completely recovered from prior surgery No use of other investigational agents within 28 days prior to and during study treatment No prior chemotherapy or radiotherapy for biliary tract cancer No other concurrent anticancer chemotherapy, radiotherapy, or investigational agent

Central Contact Person:

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

Tianqiang Song, PH.D.

Phone

+86-022-23340123

Ext

3090

tjchi@hotmail.com

Facility Information:

Facility Name

Tianjin Medical University Cancer Insititute and Hospital

City

Tianjin

State/Province

Tianjin

ZIP/Postal Code

300060

Country

China

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Tianqiang Song, PH.D.

tjchi@hotmail.com

12. IPD Sharing Statement

Learn more about this trial

Adjuvant Chemotherapy for Biliary Tract Cancer After Curative Resection

We'll reach out to this number within 24 hrs