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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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EUCTR |
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Last refreshed on:
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30 June 2019 |
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Main ID: |
EUCTR2008-001394-15-GB |
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Date of registration:
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09/10/2008 |
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Prospective Registration:
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Yes |
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Primary sponsor: |
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Public title:
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A multi-centre randomised phase II study of induction chemotherapy followed by gemcitabine or capecitabine based chemoradiotherapy (CRT) for locally advanced non-metastatic pancreatic cancer - SCALOP
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Scientific title:
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A multi-centre randomised phase II study of induction chemotherapy followed by gemcitabine or capecitabine based chemoradiotherapy (CRT) for locally advanced non-metastatic pancreatic cancer - SCALOP |
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Date of first enrolment:
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14/10/2008 |
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Target sample size:
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102 |
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Recruitment status: |
Not Recruiting |
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URL:
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https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2008-001394-15 |
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Study type:
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Interventional clinical trial of medicinal product |
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Study design:
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Controlled: no
Randomised: no
Open: no
Single blind: no
Double blind: no
Parallel group: no
Cross over: no
Other: no
If controlled, specify comparator, Other Medicinial Product: no
Placebo: no
Other: no
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Phase:
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Human pharmacology (Phase I): no
Therapeutic exploratory (Phase II): yes
Therapeutic confirmatory - (Phase III):
Therapeutic use (Phase IV):
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Countries of recruitment
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United Kingdom
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Contacts
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Key inclusion & exclusion criteria
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Inclusion criteria:
Patients meeting the following criteria may be included in the trial:
1. Age = 18
2. Histologically or cytologically proven malignancy of the pancreas
3. Locally advanced, non-metastatic, and inoperable (or operable but medically unfit for surgery) (as discussed at MDT) malignancy. The following types of interventions are allowed:
a. palliative bypass procedure
b. common bile duct stenting
4. Primary pancreatic lesion =7cm in diameter as measured by a CT scan of the thorax and abdomen that has been done within 4 weeks prior to the start of induction chemotherapy
5. WHO performance status 0-2
6. Neutrophils = 1.5 x 109/L, platelets = 100 x 109/L and haemoglobin = 10g/dL
7. Adequate liver function tests:
a. Serum bilirubin <35 micro mol/L. In participants who have had a recent biliary drain and whose bilirubin is descending, a value of =50µmol/L is acceptable.
b. AST and ALT =2.5 x ULN, alkaline phosphatase =5 x ULN
8. Adequate renal function (GFR >50ml/min (Cockcroft & Gault)
9. Capable of giving, and given, informed consent
10. Potentially fertile participants should agree to use an adequate contraception method, which must be continued for 3 months after completion of chemotherapy
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range
Exclusion criteria:
If any of the following criteria apply, participants cannot be included in the trial:
1. Women who are pregnant or breast feeding
2. Any evidence of severe uncontrolled systemic diseases including uncontrolled coronary artery disease
3. Any participants with myocardial infarction or stroke within the last 6 months
4. Previous malignancies in the preceding 5 years except for in situ cancer of the uterine cervix and adequately treated basal cell skin carcinoma and early stage malignancy
5. Renal abnormalities such as polycystic kidneys or hydronephrosis or ipsilateral single kidney.
6. Previous radiotherapy to upper abdomen
7. Recurrent cancer following definitive pancreatic surgery
8. Lymphoma or neuroendocrine tumours of the pancreas
Age minimum:
Age maximum:
Gender:
Female: yes
Male: yes
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Health Condition(s) or Problem(s) studied
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Advanced localised non-metastatic pancreatic cancer (LANPC)
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Intervention(s)
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Trade Name: Xeloda
Product Name: capecitabine
Pharmaceutical Form: Film-coated tablet
Product Name: gemcitabine
Pharmaceutical Form: Powder for solution for infusion
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Primary Outcome(s)
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Primary end point(s): 39 weeks (from registration) progression-free survival, defined according to the RECIST (Response Evaluation Criteria in Solid Tumours) criteria
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Secondary Objective: In each arm of the trial assess:
1) Toxicity, during and after treatment using NCI CTCAE v.3.0. Also, SAEs will be collected in real time
2) Quality of life
3) Overall survival
4) Progression-free survival (time to event).
5) Radiotherapy quality assurance
6) Adherence to protocol
7) Change over time of CA19-9 response
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Main Objective: To evaluate the activity, safety and feasibility of two chemoradiation treatments in the management of LANPC. If either is found to be active, safe and feasible to use it may be considered as experimental arm(s) of a future phase III trial.
Primary objective:
In each arm of the trial assess the 39 weeks (from registration) progression-free survival, defined according to the RECIST (Response Evaluation Criteria in Solid Tumours) criteria.
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Secondary ID(s)
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96169987
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WCTU012
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Source(s) of Monetary Support
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Ethics review
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Status: Approved
Approval date:
Contact:
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