Adjuvant Chemotherapy for Biliary Tract Cancer After Curative Resection (AdBTC-1)
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|ClinicalTrials.gov Identifier: NCT03779035|
Recruitment Status : Recruiting
First Posted : December 18, 2018
Last Update Posted : December 18, 2018
|Condition or disease||Intervention/treatment||Phase|
|Cholangiocarcinoma Gall Bladder Carcinoma||Drug: Gemcitabine Drug: Capecitabine||Phase 3|
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.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||460 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Adjuvant Chemotherapy With Gemcitabine and Capecitabine Compared to Capecitabine for Biliary Tract Cancer After Curative Resection|
|Estimated Study Start Date :||December 15, 2018|
|Estimated Primary Completion Date :||December 31, 2020|
|Estimated Study Completion Date :||December 31, 2023|
Experimental: Gemcitabine plus Capecitabine
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.
Active Comparator: Capecitabine
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.
- Disease free survival (DFS) rate [ Time Frame: at 24 months ]DFS
- Overall survival (OS) rate [ Time Frame: at 24 months ]OS
- Disease free survival (DFS) rate [ Time Frame: at 60 months ]DFS
- Overall survival (OS) rate [ Time Frame: at 60 months ]OS
- The rate of patients with hepatic or locoregional recurrence [ Time Frame: 24 months ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03779035
|Contact: Tianqiang Song, PH.D.||+86-022-23340123 ext firstname.lastname@example.org|
|Tianjin Medical University Cancer Insititute and Hospital||Recruiting|
|Tianjin, Tianjin, China, 300060|
|Contact: Tianqiang Song, PH.D. email@example.com|