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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

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ClinicalTrials.gov Identifier: NCT02798510
Recruitment Status : Unknown
Verified June 2016 by Zhi-Gang Ren, Fudan University.
Recruitment status was:  Recruiting
First Posted : June 14, 2016
Last Update Posted : June 22, 2016
Sponsor:
Information provided by (Responsible Party):
Zhi-Gang Ren, Fudan University

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

Condition or disease Intervention/treatment Phase
Malignant Neoplasm Other Gallbladder/Extrahepatic Bile Duct Radiation: Concurrent Chemoradiotherapy Drug: capecitabine Drug: gemcitabine Phase 3

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 140 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Study Start Date : April 2016
Estimated Primary Completion Date : April 2019

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: 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)
Radiation: Concurrent Chemoradiotherapy
Drug: capecitabine
Drug: gemcitabine
Active Comparator: 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
Drug: capecitabine
Drug: gemcitabine



Primary Outcome Measures :
  1. overall survival [ Time Frame: 24 months ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

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): NCT02798510


Contacts
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Contact: zhigang ren, MD 64175590 ext 8627 zhigang-ren@163.com

Locations
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China, Shanghai
Fudan university cancer hospital Recruiting
Shanghai, Shanghai, China, 200032
Contact: zhigang ren, MD    64175590 ext 8627    zhigang-ren@163.com   
Sponsors and Collaborators
Fudan University
Investigators
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Principal Investigator: zhigang ren, MD Fudan University

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Responsible Party: Zhi-Gang Ren, professor, Fudan University
ClinicalTrials.gov Identifier: NCT02798510     History of Changes
Other Study ID Numbers: FDRT-PG001
First Posted: June 14, 2016    Key Record Dates
Last Update Posted: June 22, 2016
Last Verified: June 2016

Keywords provided by Zhi-Gang Ren, Fudan University:
Gallbladder Carcinoma
Extrahepatic Cholangiocarcinoma
Chemoradiotherapy

Additional relevant MeSH terms:
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Cholangiocarcinoma
Neoplasms
Adenocarcinoma
Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Gemcitabine
Capecitabine
Antimetabolites, Antineoplastic
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Antiviral Agents
Anti-Infective Agents
Enzyme Inhibitors
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs