Capecitabine or Observation After Surgery in Treating Patients With Biliary Tract Cancer

Sponsor

University Hospital Southampton NHS Foundation Trust (Other)

Overall Status

Completed

CT.gov ID

NCT00363584

Collaborator

(none)

360

Enrollment

Locations

7.8

Patients Per Site

Study Details

Study Description

Brief Summary

RATIONALE: Drugs used in chemotherapy, such as capecitabine, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving capecitabine after surgery may kill any tumor cells that remain after surgery. Sometimes, after surgery, the tumor may not need more treatment until it progresses. In this case, observation may be sufficient. It is not yet known whether capecitabine is more effective than observation in treating biliary tract cancer.

PURPOSE: This randomized phase III trial is studying capecitabine to see how well it works compared with observation in treating patients with biliary tract cancer.

Condition or Disease	Intervention/Treatment	Phase
Extrahepatic Bile Duct Cancer Gallbladder Cancer Liver Cancer	Drug: capecitabine Other: clinical observation Procedure: adjuvant therapy	Phase 3

Detailed Description

OBJECTIVES:

Primary

To determine whether adjuvant chemotherapy with capecitabine has any effect on 2-year survival compared to expectant treatment alone (observation) in patients who have undergone a macroscopically complete surgical resection of a biliary tract cancer.

Secondary

To compare capecitabine versus observation in terms of 5-year survival, relapse-free survival, toxicity, quality of life, and health economics.

OUTLINE: This is a multicenter, prospective, randomized study. Patients are stratified according to surgical center, disease site (hilar/extrahepatic cholangiocarcinoma vs intrahepatic cholangiocarcinoma vs gallbladder vs intrapancreatic/common bile duct), type of resection (R0 vs R1), and ECOG performance status (0 vs 1 vs 2). Patients are randomized to 1 of 2 treatment arms.

Arm I: Patients receive oral capecitabine twice a day on days 1-14. Treatment repeats every 3 weeks for 8 courses in the absence of disease progression or unacceptable toxicity.
Arm II: Patients undergo expectant treatment (observation). Quality of life is assessed at baseline, every 3 months for 1 year, and then every 6 months for 1 year.

All patients are followed for up to 5 years post-randomization.

Peer Reviewed and Funded or Endorsed by Cancer Research UK

PROJECTED ACCRUAL: A total of 360 patients will be accrued for this study.

Study Design

Study Type:

Interventional

Anticipated Enrollment :

360 participants

Allocation:

Randomized

Primary Purpose:

Treatment

Official Title:

A Randomised Clinical Trial Evaluating Adjuvant Chemotherapy With Capecitabine Compared to Expectant Treatment Alone (Observation) Following Surgery for Biliary Tract Cancer

Study Start Date :

Mar 1, 2006

Actual Primary Completion Date :

Aug 1, 2013

Outcome Measures

Primary Outcome Measures

Survival at 2 years []

Secondary Outcome Measures

Survival at 5 years []
Relapse-free survival []
Toxicity []
Quality of life []
Health economics []

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

DISEASE CHARACTERISTICS:

Histologically confirmed biliary tract cancer (including intrahepatic or extrahepatic/hilar cholangiocarcinoma or muscle invasive gallbladder cancer or cancer of the distal bile duct)
Must have undergone a radical surgical approach which includes liver resection, pancreatic resection, or less commonly both
Patients with pathological evidence of microscopic involvement of the margins of the excised specimen are eligible as long as resection is macroscopically complete
Must be able to start treatment within 12 weeks of surgery
No pancreatic or periampullary cancer
No mucosal gallbladder cancer

PATIENT CHARACTERISTICS:

ECOG performance status 0-2
Urea < 1.5 times upper limit of normal (ULN)
Creatinine < 1.5 times ULN
Glomerular filtration rate ≥ 60 mL/min (if < 60 mL/min, adequate renal function for capecitabine must be confirmed by isotope EDTA)
Hemoglobin ≥ 10 g/dL
WBC ≥ 3,000/mm³
Absolute neutrophil count ≥ 1,500/mm³
Platelet count ≥ 100,000/mm³
Bilirubin ≤ 3 times ULN
ALT and AST ≤ 5 times ULN
Adequate surgical biliary drainage with no evidence of infection
Not pregnant or nursing
Negative pregnancy test for women of childbearing age and childbearing potential
Fertile patients must use effective contraception during study treatment and for at least 3 months after study treatment has ended
Must provide written informed consent
No history of other malignant diseases within the past 5 years other than adequately treated nonmelanoma skin cancer or in situ carcinoma of the uterine cervix
No serious co-existing medical condition likely to interfere with protocol treatment, including a potential serious infection
No evidence of significant clinical disorder or laboratory finding that makes it undesirable for the patient to participate in the trial
No psychological, familial, sociological, or geographical factors considered likely to preclude study compliance
No other serious uncontrolled medical conditions
No unresolved biliary tree obstruction

PRIOR CONCURRENT THERAPY:

See Disease Characteristics
Completely recovered from prior surgery
No use of other investigational agents within 28 days prior to and during study treatment
No prior chemotherapy or radiotherapy for biliary tract cancer
No other concurrent anticancer chemotherapy, radiotherapy, or investigational agent

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Basildon University Hospital	Basildon	England	United Kingdom	SS16 5NL
2	Basingstoke and North Hampshire NHS Foundation Trust	Basingstoke	England	United Kingdom	RG24 9NA
3	Cancer Research UK Clinical Trials Unit - Birmingham	Birmingham	England	United Kingdom	B15 2TT
4	Royal Bournemouth Hospital	Bournemouth	England	United Kingdom	BH7 7DW
5	Bristol Haematology and Oncology Centre	Bristol	England	United Kingdom	BS2 8ED
6	Addenbrooke's Hospital	Cambridge	England	United Kingdom	CB2 2QQ
7	Walsgrave Hospital	Coventry	England	United Kingdom	CV2 2DX
8	Princess Alexandra Hospital	Essex	England	United Kingdom	CM20 1QX
9	St. Luke's Cancer Centre at Royal Surrey County Hospital	Guildford	England	United Kingdom	GU2 7XX
10	Calderdale Royal Hospital	Halifax	England	United Kingdom	HX3 0PW
11	Huddersfield Royal Infirmary	Huddersfield, West Yorks	England	United Kingdom	HD3 3EA
12	Cancer Research UK Clinical Centre at St. James's University Hospital	Leeds	England	United Kingdom	LS16 6QB
13	Leicester Royal Infirmary	Leicester	England	United Kingdom	LE1 5WW
14	Leicester General Hospital	Leicester	England	United Kingdom	LE5 4PW
15	Royal Liverpool University Hospital	Liverpool	England	United Kingdom	L7 8XP
16	Aintree University Hospital	Liverpool	England	United Kingdom	L9 7AL
17	Saint Bartholomew's Hospital	London	England	United Kingdom	EC1A 7BE
18	Helen Rollason Cancer Care Centre at North Middlesex Hospital	London	England	United Kingdom	N18 1QX
19	UCL Cancer Institute	London	England	United Kingdom	NW3 2QG
20	St. Thomas' Hospital	London	England	United Kingdom	SE1 7EH
21	King's College Hospital	London	England	United Kingdom	SE5 9RS
22	Royal Marsden - London	London	England	United Kingdom	SW3 6JJ
23	Hammersmith Hospital	London	England	United Kingdom	W12 OHS
24	University College of London Hospitals	London	England	United Kingdom	WIT 3AA
25	Maidstone Hospital	Maidstone	England	United Kingdom	ME16 9QQ
26	Christie Hospital	Manchester	England	United Kingdom	M20 4BX
27	North Manchester General Hospital - Penine Actute Hospitals Trust	Manchester	England	United Kingdom	M8 6RB
28	Clatterbridge Centre for Oncology	Merseyside	England	United Kingdom	CH63 4JY
29	Northern Centre for Cancer Treatment at Newcastle General Hospital	Newcastle-Upon-Tyne	England	United Kingdom	NE4 6BE
30	Freeman Hospital	Newcastle-Upon-Tyne	England	United Kingdom	NE7 7DN
31	St. Mary's Hospital	Newport	England	United Kingdom	PO30 5TG
32	Nottingham City Hospital	Nottingham	England	United Kingdom	NG5 1PB
33	Derriford Hospital	Plymouth	England	United Kingdom	PL6 8DH
34	Portsmouth Oncology Centre at Saint Mary's Hospital	Portsmouth Hants	England	United Kingdom	PO3 6AD
35	Alexandra Healthcare NHS	Redditch, Worcestershire	England	United Kingdom	B98 7UB
36	Salisbury District Hospital	Salisbury	England	United Kingdom	SP2 8BJ
37	Cancer Research Centre at Weston Park Hospital	Sheffield	England	United Kingdom	S1O 2SJ
38	Southampton General Hospital	Southampton	England	United Kingdom	SO16 6YD
39	Royal Marsden - Surrey	Sutton	England	United Kingdom	SM2 5PT
40	Southend University Hospital NHS Foundation Trust	Westcliff-On-Sea	England	United Kingdom	SS0 0RY
41	Yeovil District Hospital	Yeovil	England	United Kingdom	BA21 4AT
42	Ninewells Hospital	Dundee	Scotland	United Kingdom	DD1 9SY
43	Edinburgh Cancer Centre at Western General Hospital	Edinburgh	Scotland	United Kingdom	EH4 2XU
44	Beatson West of Scotland Cancer Centre	Glasgow	Scotland	United Kingdom	G12 0YN
45	Perth Royal Infirmary	Perth	Scotland	United Kingdom	PH1 1NX
46	Velindre Cancer Center at Velindre Hospital	Cardiff	Wales	United Kingdom	CF14 2TL