A Phase II Study of concurrent chemo-radiotherapy with Gemcitabine followed by chemotherapy with Gemcitabine and Cisplatin for unresectable localized perihilar cholangiocarcinoma

Status

Unknown

Phases

Phase 2

Study type

Interventional

Source

CRIS

Registry ID

KCT0003478

Enrollment

Registered

2019-02-08

Start date

2018-05-23

Completion date

Unknown

Last updated

2020-03-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Interventions

Drug, Radiation : Chemotherapy using cisplatin (25mg / m2) and gemcitabine (1000mg / m2) after chemoradiotherapy combined with gemcitabine (400mg / m2 / week) and radiotherapy (PTV1: 50-60Gy / 10fx, P

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: Pathologically confirmed adenocarcinoma located in the bile duct of the liver, If surgically unresectable If there is no systemic and intrahepatic metastasis If there is biliary obstruction, there is no obstruction due to drainage before the clinical trial If the tumor is included in the radiation field (maximum: 10 x 10 cm) If the tumor is measurable, If there is no history of radiation therapy in the abdomen Age: = 18 years old Performance status: ECOG 0-1 With adequate bone marrow, renal, and liver function: HB =9.0 g/dl, ANC =1,500/mm3, PLT = 100,000/mm3, Bilirubin <3.0 mg/dl, AST/ALT/ALP): < WNL X 3, Creatinine: <WNL x 1.5 If you decide to voluntarily participate in this trial and you have signed a written informed consent Age: < 18 years old

Exclusion criteria

Exclusion criteria: Biliary cancer of other histological type except adenocarcinoma. Cholangiocarcinoma with a epicenter other than perhilar area In case of peritoneal seeding and distant metastasis Performance status: ECOG 2-4.Previous radiotherapy history to target area The patients with other tumors not treated in addition to biliary cancer within the last 2 years. However, cervical intraepithelial and thyroid cancer and early (I, II) prostate cancer are acceptable. If you have any of the following serious systemic diseases: congestive heart failure (NYHA class III or IV); unstable angina within the last 6 months, myocardial infarction, Arrhythmia requiring treatment beyond 2nd degree AV block, uncontrolled hypertension, Child C liver cirrhosis, interstitial pneumonia, pulmonary adenomatosis, Mental illness that may interfere with treatment and clinical trials, unstable diabetes mellitus, uncontrolled ascites or pleural effusion, active infection If the investigator judges that the patient is inadequate to participate in the clinical trial

Design outcomes

Primary

Measure	Time frame
Complaince of Treatment: compliance was defined as the fraction of patients enrolled in this study who completed chemotherapy with cisplatin and gemcitabine (8 cycles) following chemotherapy with chemotherapy plus planned gemcitabine plus radiation therapy.	—

Secondary

Measure	Time frame
Overall survival and disease free survival The ovarall and disease free survival time is defined as the date of occurrence or cut-off date of the event (death or progress of the disease) based on the diagnosis date. The occurrence date means that the death or disease progress has been confirmed by all causes, and the truncation day means the last day when it is determined that the event did not occur. In case of non - traceability, the cutting date is the day on which the survival is confirmed before it becomes impossible to trace. The lesion criteria date is calculated based on the date of radiological examination of the findings. Tumor respnse evaluated by imaging study: the radiologic response response score is calculated as the fraction of subjects who showed 'complete remission' or 'partial remission' according to the RECIST criteria. Expression of gene: Gene expression level in tumor and blood samples	—

Measure

Time frame

Overall survival and disease free survival The ovarall and disease free survival time is defined as the date of occurrence or cut-off date of the event (death or progress of the disease) based on the diagnosis date. The occurrence date means that the death or disease progress has been confirmed by all causes, and the truncation day means the last day when it is determined that the event did not occur. In case of non - traceability, the cutting date is the day on which the survival is confirmed before it becomes impossible to trace. The lesion criteria date is calculated based on the date of radiological examination of the findings. Tumor respnse evaluated by imaging study: the radiologic response response score is calculated as the fraction of subjects who showed 'complete remission' or 'partial remission' according to the RECIST criteria. Expression of gene: Gene expression level in tumor and blood samples

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Countries

Korea, Republic of

Contacts

Public ContactMeeyoung Lee

NCC Hospital

Outcome results