E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Partients who have undergone surgical resection of a biliary tract cancer (including intrahepatic and extrahepatic cholangiocarcinoma, cancer of the distal bile duct and muscle invasive gallbladder cancer). |
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MedDRA Classification |
E.1.3 | Condition being studied is a rare disease | No |
E.2 Objective of the trial |
E.2.1 | Main objective of the trial |
To determine the survival at 2-years of patients treated with capecitabine, compared to those undergoing observation alone, following complete macroscopic surgical resection of biliary tract cancer. |
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E.2.2 | Secondary objectives of the trial |
To compare capecitabine versus observation in terms of: 5-year survival Relapse free survival Toxicity Quality of Life Health Economics |
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E.2.3 | Trial contains a sub-study | Yes |
E.2.3.1 | Full title, date and version of each sub-study and their related objectives |
Trans- BILCAP Sub-study The initial aim of this study is to prospectively collect tissue blocks and blood from all BILCAP patients. The BILCAP Trial Office will request pathological information at time of randomisation for all patients including histology number, location of paraffin tumour blocks and reporting consultant pathologist. Subject to patient consent, this will allow the prospective collection of patient material including a single pre treatment blood sample. Material will be centralised at the Cancer Sciences Tissue Bank in Southampton.
If patients do not wish to participate they can still take part in the BILCAP trial. The Trans-BILCAP sub-study is a unique opportunity to collect material for translational research of cancer of the biliary tract.
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E.3 | Principal inclusion criteria |
-Patients with histologically confirmed biliary tract cancer who have undergone a macroscopically complete resection with curative intent
-Radical surgical approach must have been employed (including liver resection)
-ECOG performance status less than/equal to 2
- Adequate renal, haematological and liver function (details specified in protocol)
- Age 18 years or over
-No history of other malignant diseases (except non-melantotic skin cancer or in-situ carcimoma of cervix)
-Women of childbearing potential must not be pregnant and must use adequate contraception during study and for 3 months after the study treatment
-Written informed consent
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E.4 | Principal exclusion criteria |
-Pancreatic or Ampullary cancer
-Mucosal gallbladder cancer
-Incomplete recovery from previous surgery or unresolved biliary tree obstruction
-Use of other investigational agents during the study or within 4 weeks of planned entry into the study.
-History of second malignancy within 5 years of trial entry, except cervical carcinoma in-situ or non-melanotic skin cancer.
-Any previous chemotherapy, radiotherapy, biological or hormone therapy given for biliary tract cancer.
-A serious co-exisiting medical condition inlcuding a potential serious infection.
-Evidence of significant clinical disorder or laboratory finding which makes it undesirable for the patient to participate in the trial.
-Any other serious uncontrolled medical conditions
-Pregnant or breastfeeding women
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E.5 End points |
E.5.1 | Primary end point(s) |
Primary endpoint: 2-year survival
Secondary endpoints: 5-year survival Relapse free survival Toxicity Quality of Life Health Economics |
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E.6 and E.7 Scope of the trial |
E.6 | Scope of the trial |
E.6.1 | Diagnosis | No |
E.6.2 | Prophylaxis | No |
E.6.3 | Therapy | Yes |
E.6.4 | Safety | No |
E.6.5 | Efficacy | Yes |
E.6.6 | Pharmacokinetic | No |
E.6.7 | Pharmacodynamic | No |
E.6.8 | Bioequivalence | No |
E.6.9 | Dose response | No |
E.6.10 | Pharmacogenetic | Information not present in EudraCT |
E.6.11 | Pharmacogenomic | No |
E.6.12 | Pharmacoeconomic | Yes |
E.6.13 | Others | Information not present in EudraCT |
E.7 | Trial type and phase |
E.7.1 | Human pharmacology (Phase I) | No |
E.7.1.1 | First administration to humans | No |
E.7.1.2 | Bioequivalence study | No |
E.7.1.3 | Other | No |
E.7.1.3.1 | Other trial type description | |
E.7.2 | Therapeutic exploratory (Phase II) | No |
E.7.3 | Therapeutic confirmatory (Phase III) | Yes |
E.7.4 | Therapeutic use (Phase IV) | No |
E.8 Design of the trial |
E.8.1 | Controlled | Yes |
E.8.1.1 | Randomised | Yes |
E.8.1.2 | Open | Yes |
E.8.1.3 | Single blind | No |
E.8.1.4 | Double blind | No |
E.8.1.5 | Parallel group | Information not present in EudraCT |
E.8.1.6 | Cross over | No |
E.8.1.7 | Other | No |
E.8.2 | Comparator of controlled trial |
E.8.2.1 | Other medicinal product(s) | No |
E.8.2.2 | Placebo | No |
E.8.2.3 | Other | Yes |
E.8.2.3.1 | Comparator description |
Standard observation (i.e. follow up with no scheduled chemotherapy) |
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E.8.3 |
The trial involves single site in the Member State concerned
| No |
E.8.4 | The trial involves multiple sites in the Member State concerned | Yes |
E.8.5 | The trial involves multiple Member States | No |
E.8.6 Trial involving sites outside the EEA |
E.8.6.1 | Trial being conducted both within and outside the EEA | No |
E.8.6.2 | Trial being conducted completely outside of the EEA | Information not present in EudraCT |
E.8.7 | Trial has a data monitoring committee | Information not present in EudraCT |
E.8.8 |
Definition of the end of the trial and justification where it is not the last
visit of the last subject undergoing the trial
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Patients will be recruited into the trial over a four year and eleven month period, and will be followed up for 5 years after randomisation. The end of the trial will be the last of these trial-specific follow-up visits made by a patient undergoing the trial. |
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E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | 8 |
E.8.9.1 | In the Member State concerned months | 0 |
E.8.9.1 | In the Member State concerned days | |