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Title

BBC01- BBC: Phase II study of neoadjuvant cisplatin and gemcitabine chemotherapy versus upfront surgery in patients with locally advanced / borderline resectable proximal biliary tract cancer:


Basic Trial Information

Phase Type Status Age Sponsor Protocol IDs
II CTIMP Funded and in setup 18 and over Clatterbridge Eudract No: 2014-002382-30
Isrctn No:

Trial Lead Organisations

- LCTU / North West Cancer Research


Trial Start Date

Trial Not Open


Trial Coordinator

Neil Olsson Brown


Trial Coordinator Email Address

neilob@liv.ac.uk


Trial Coordinator Contact No

0151 7948244


Website Treatment  

Treatment arm patients will receive combined chemotherapy consisting of cisplatin 25 mg/m2 plus gemcitabine 1000 mg/m2 on days 1 and 8 of a 21-day cycle. These patients will receive four cycles (12 weeks) of treatment followed by re-discussion with the patient's clinical team. All patient will receive surgery

Trial Endpoints  


Primary Outcome  

  • Overall survival


Secondary Outcomes  

  • Pathological Response
  • Surgical Safety
  • Objective response rate
  • Resection with a curative intent: R0 resection rate
  • QOL

Eligibility  

 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 ³ 10 g/dl*

                           iii.          White blood cell count (WBC) ³ 3.0 x 109/L

                          iv.          Absolute neutrophil count (ANC) ³ 1.5 x 109/L

                            v.          Platelet count ³ 100 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 < 5 x ULN)

                           iii.          Alkaline phosphatase £ 5 x ULN

g)    Adequate renal function:

                              i.          Serum urea < 1.5 x ULN

                            ii.          Serum creatinine < 1.5 x ULN

                           iii.          Calculated GFR ³ 60 mL/min using the Cockcroft-Gault formula (see Appendix B; page 62).

h)    No evidence of active uncontrolled infection (patients on long-term antibiotics are eligible provided signs of active infection have resolved)

i)      Women of child-bearing potential must have a negative pregnancy test prior to study entry AND be using two methods of adequate contraception, which must be continued for 6 months after completion of treatment. Reliable methods of contraception should be used consistently and correctly. Acceptable methods include barrier methods, implants, injectables, combined oral contraceptive methods, some intra-uterine devices (IUDs), sexual abstinence or vasectomised partner.

j)      Patient must have given written informed consent

 

 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 <1.5 g in a 24-hour period or protein/creatinine ratio < 1.5

k)        Mean QTc with Bazetts correction >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

t)         Any patient that has had a live vaccine within 30 days of randomization.  


UK: ENGLAND

  • Liverpool, LCTU (Daniel Palmer)