Resectable Biliary Tract Carcinoma MedDRA version: 18.0 Level: LLT Classification code 10017621 Term: Gallbladder carcinoma localized System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA version: 18.0 Level: PT Classification code 10008593 Term: Cholangiocarcinoma System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA version: 18.0 Level: LLT Classification code 10034446 Term: Periampullary
Conditions
Interventions
Trade Name: Gemzar
Product Code: SUB02324MIG
Pharmaceutical Form: Solution for injection in pre-filled pen
INN or Proposed INN: Gemcitabine Hydrochloride
CAS Number: 122111-03-9
Concentration unit: mg
Sponsors
The Clatterbridge Cancer Centre NHS Foundation Trust
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: a) A centrally confirmed histopathological / cytological diagnosis of biliary tract carcinoma b) Radiological confirmation of intrahepatic/hilar location c) ECOG performance status 0, 1, or 2 d) Age = 18 e) Estimated life expectancy > 3 months i. Adequate haematological function: ii. Haemoglobin * 10 g/dl* iii. White blood cell count (WBC) * 3.0 x 109/L iv. Absolute neutrophil count (ANC) * 1.5 x 109/L v. Platelet count * 100 x 109/L vi. *prior transfusions for patients with low haemoglobin are allowed f) Adequate liver function: i. Total bilirubin =1.5 x upper limit of normal (ULN) (except for patients with known documented cases of Gilbert’s syndrome) ii. ALT and/or AST ? 2.5 x ULN (If liver metastases are present, ALT or AST =65 years) no F.1.3.1 Number of subjects for this age range 50
Exclusion criteria
Exclusion criteria: a) Radiological evidence suggesting inability to resect with curative intent whilst maintaining adequate vascular inflow and outflow, and sufficient future liver remnant b) Radiological evidence of direct invasion into adjacent organs c) Radiological evidence of extrahepatic metastatic disease d) Significant haemorrhage (>30 mL bleeding/episode in previous 3 months) or haemoptysis (>5 mL fresh blood) within 4 weeks of recruitment. e) Patients with history of poorly controlled hypertension with resting blood pressure >150/100 mmHg in the presence or absence of a stable regimen of anti-hypertensive therapy, or patients who are requiring maximal doses of calcium channel blockers to stabilise blood pressure f) Incomplete recovery (CTCAE grade >1) from previous anti-cancer therapy side effects (except haematological toxicity – see inclusion criteria for adequate haematological function), or alopecia g) Prior systemic chemotherapy for locally advanced or metastatic biliary disease is not allowed. h) Unresolved biliary tree obstruction i) Any evidence of severe or uncontrolled systemic diseases which, in the view of the investigator, makes it undesirable for the patient to participate in the trial (e.g. unstable or uncompensated respiratory, cardiac, hepatic or renal disease) j) Greater than +1 proteinuria on two consecutive dipsticks taken no less than 1 week apart, unless urinary protein 480 msec in screening ECG or history of familial long QT syndrome l) Recent (<14 days) major thoracic or abdominal surgery prior to recruitment, or a surgical incision that is not fully healed m) Pregnant or breast-feeding women n) Known risk of the patient transmitting HIV, hepatitis B or C via infected blood o) Treatment with an investigational drug within 30 days prior to recruitment p) Other concomitant anti-cancer therapy (except steroids) q) Patients undergoing current treatment with curative intent r) History of prior malignancy that will interfere with the response evaluation (exceptions include in-situ carcinoma of the cervix treated by cone-biopsy/resection, non-metastatic basal and/or squamous cell carcinomas of the skin, any early stage (stage I) malignancy adequately resected for cure greater than 5 years previously) s) Any psychiatric or other disorder likely to impact on informed consent
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To assess if chemotherapy followed by curative surgical resection increases overall survival rates in patients with biliary tract cancer when compared to surgery alone. ;Secondary Objective: • To assess the patient's response to the chemotherapy. • To assess the safety of surgery • To assess quality of life during and after treatment ;Primary end point(s): Overall survival;Timepoint(s) of evaluation of this end point: Overall survival is defined as the time from randomization to the earliest of death, trial closure or date of last visit (in the case of patients lost to follow-up before trial closure). Patients lost to follow-up or alive at trial closure will be censored at the date of last visit or trial closure date (as appropriate). | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): - Pathological Response - Surgical Safety - Objective Response Rate - Resection with Curative Intent (R) - Quality of Life;Timepoint(s) of evaluation of this end point: - Pathological Response - will be assessed locally using the Rubbia-Brandt system post resection - Surgical Safety will be assessed 90-day post surgery using Dindo-Clavien grading system - Objective Response Rate - Measured using RECIST criteira v1.1. CT scans will be at M3 (±1w), M6 (±1w), M9 (±1w), M12 (±1w), and 6 monthly until the patient's progression. - Resection with Curative Intent (R0)- each resection will be classed as Pathological R0 or otherwise and a local pathological review of all resections will be undertaken post resection. - Quality of Life - EORTC Bil 21 QLQ30 and 8D questionnaires will be collected will be at M3 (±1w), M6 (±1w), M9 (±1w), M12 (±1w), and 6 monthly until the patient's progression and will be used to permit estimation of incremental QALYs | — |
Countries
United Kingdom
Contacts
Public ContactSenior Trial Co-ordinator
Liverpool Cancer Trials Unit
Outcome results
None listed