Clinical Trial of Adjuvant Chemotherapy Followed by Concurrent Chemoradiotherapy Compared With Adjuvant Chemotherapy Alone in Patients With Gallbladder Carcinoma and Extrahepatic Cholangiocarcinoma
NCT ID: NCT02798510
Last Updated: 2016-06-22
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE3
140 participants
INTERVENTIONAL
2016-04-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Arm 1
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)
Concurrent Chemoradiotherapy
capecitabine
gemcitabine
Arm 2
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
capecitabine
gemcitabine
Interventions
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Concurrent Chemoradiotherapy
capecitabine
gemcitabine
Eligibility Criteria
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Inclusion Criteria
* 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
* 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.
18 Years
70 Years
ALL
No
Sponsors
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Fudan University
OTHER
Responsible Party
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Zhi-Gang Ren
professor
Principal Investigators
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zhigang ren, MD
Role: PRINCIPAL_INVESTIGATOR
Fudan University
Locations
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Fudan university cancer hospital
Shanghai, Shanghai Municipality, China
Countries
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Central Contacts
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Facility Contacts
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References
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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.
Other Identifiers
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FDRT-PG001
Identifier Type: -
Identifier Source: org_study_id
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