Gemcitabine, Capecitabine, and Radiation Therapy in Treating Patients With Locally Advanced Pancreatic Cancer That Cannot Be Removed by Surgery
NCT ID: NCT01032057
Last Updated: 2018-10-26
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE2
114 participants
INTERVENTIONAL
2009-07-31
2013-06-30
Brief Summary
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PURPOSE: This randomized phase II trial is comparing the side effects of two regimens of gemcitabine and capecitabine given together with radiation therapy and to see how well they work in treating patients with locally advanced pancreatic cancer that cannot be removed by surgery.
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Detailed Description
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* To evaluate the activity, safety, and feasibility of induction chemotherapy comprising gemcitabine and capecitabine followed by two different schedules of chemoradiotherapy comprising gemcitabine or capecitabine and radiotherapy in patients with locally advanced, nonmetastatic, unresectable pancreatic cancer.
* To determine which of the two experimental arms gives the highest generic and disease-specific aspects of health-related quality of life (HRQL) following treatment.
* To determine how HRQL varies during treatment and follow up in both arms.
OUTLINE: This is a multicenter study.
All patients receive a first induction therapy comprising gemcitabine IV on days 1, 8, and 15 and oral capecitabine twice daily on days 1-21. Treatment repeats every 28 days for 3 courses in the absence of disease progression or unacceptable toxicity. Following the first induction therapy, patients with a WHO performance status of 0-1 who are responding or have stable disease that can be encompassed within a radically treatable radiotherapy volume are randomized to 1 of 2 treatment arms.
* Arm I:
* Second induction therapy (weeks 13-16): Patients receive gemcitabine IV once daily on days 1, 8, and 15 and oral capecitabine twice daily on days 1-21.
* Chemoradiotherapy (weeks 17-22): Patients receive gemcitabine IV once weekly on day 1 and undergo conformal radiotherapy 5 days a week for 5.5 weeks.
* Arm II:
* Second induction therapy (weeks 13-16): Patients receive gemcitabine IV once daily on days 1, 8, and 15 and oral capecitabine twice daily on days 1-21.
* Chemoradiotherapy (weeks 17-22): Patients receive oral capecitabine twice daily on days 1-5 and undergo conformal radiotherapy 5 days a week for 5.5 weeks.
Patients complete quality-of-life questionnaires QLQ-C30 and PAN26 at baseline and at 17, 23, 26, 39, and 52 weeks.
After completion of study treatment, patients are followed every 3 months.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Gemcitabine
GEMCAP induction chemotherapy (28 day cycle of IV gemcitabine 1000mg/m2 day 1, 8,15 and capecitabine 830mg/m2 bd for 21 days po) followed by gemcitabine 300mg/m2 weekly (IV) + 50.4Gy radiation over five and half weeks (1.8Gy per fraction, Monday-Friday)
capecitabine
gemcitabine hydrochloride
quality-of-life assessment
3-dimensional conformal radiation therapy
chemoradiotherpay with capecitabine
GEMCAP induction chemotherapy (28 day cycle of IV gemcitabine 1000mg/m2 day 1, 8,15 and capecitabine 830mg/m2 bd for 21 days po), followed by capecitabine 830mg/m2 bd (po, Mon-Fri) + 50.4Gy radiation over five and half weeks (1.8Gy per fraction, Monday-Friday)
capecitabine
gemcitabine hydrochloride
quality-of-life assessment
3-dimensional conformal radiation therapy
Interventions
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capecitabine
gemcitabine hydrochloride
quality-of-life assessment
3-dimensional conformal radiation therapy
Eligibility Criteria
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Inclusion Criteria
* Histologically or cytologically confirmed adenocarcinoma of the pancreas
* Locally advanced, nonmetastatic, inoperable, or operable (but medically unfit for surgery) disease
* Palliative bypass procedure allowed
* Common bile duct stenting allowed
* Primary pancreatic lesion ≤ 7 cm in diameter as measured by CT scan of the thorax and abdomen within 4 weeks prior to registration
* No recurrent cancer following definitive pancreatic surgery
PATIENT CHARACTERISTICS:
* WHO performance status (PS) 0-2
* Neutrophil count ≥ 1.5 x 10\^9/L
* Platelet count ≥ 100 x 10\^9/L
* Hemoglobin ≥ 10 g/dL
* Serum bilirubin \< 35 μmol/L (50 μmol/L allowed for patients who have had a recent biliary drain and whose bilirubin is descending)
* AST/ALT ≤ 2.5 times upper limit of normal (ULN)
* Alkaline phosphatase ≤ 5 times ULN
* GFR \> 50 mL/min
* Not pregnant or nursing
* Negative pregnancy test
* Fertile patients must use effective contraception during and for 12 weeks after completion of study therapy
* No evidence of severe uncontrolled systemic diseases including uncontrolled coronary artery disease
* No myocardial infarction or stroke within the past 6 months
* No prior malignancies within the past 5 years except for carcinoma in situ of the cervix, adequately treated basal cell skin carcinoma, or any early-stage malignancy
* No suspected DPD deficiency
* No renal abnormalities (e.g., adult polycystic kidney disease, hydronephrosis, or ipsilateral single kidney)
* Must meet the following additional criteria for randomization:
* WHO PS 0-1
* Loss of weight no greater than 10% of that at baseline
PRIOR CONCURRENT THERAPY:
* See Disease Characteristics
* At least 4 weeks since prior and no concurrent sorivudine or analogues
* No prior radiotherapy to the upper abdomen
* No concurrent methotrexate
* No concurrent allopurinol
18 Years
120 Years
ALL
No
Sponsors
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Lisette Nixon
OTHER
Responsible Party
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Lisette Nixon
Dr
Principal Investigators
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Somnath Mukherjee
Role: PRINCIPAL_INVESTIGATOR
Northampton General Hospital
Locations
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Queen Elizabeth Hospital at University Hospital of Birmingham NHS Trust
Birmingham, England, United Kingdom
Bristol Haematology and Oncology Centre
Bristol, England, United Kingdom
Addenbrooke's Hospital
Cambridge, England, United Kingdom
Queen Alexandra Hospital
Cosham, England, United Kingdom
Castle Hill Hospital
Cottingham, England, United Kingdom
Diana Princess of Wales Hospital
Grimsby, England, United Kingdom
St. Luke's Cancer Centre at Royal Surrey County Hospital
Guildford, England, United Kingdom
Leeds Cancer Centre at St. James's University Hospital
Leeds, England, United Kingdom
Leicester Royal Infirmary
Leicester, England, United Kingdom
Helen Rollason Cancer Care Centre at North Middlesex Hospital
London, England, United Kingdom
Royal Free Hospital
London, England, United Kingdom
Hammersmith Hospital
London, England, United Kingdom
Northampton General Hospital
Northampton, England, United Kingdom
Scarborough General Hospital
Scarborough, England, United Kingdom
Cancer Research Centre at Weston Park Hospital
Sheffield, England, United Kingdom
Southampton General Hospital
Southampton, England, United Kingdom
Musgrove Park Hospital
Taunton, England, United Kingdom
Ninewells Hospital
Dundee, Scotland, United Kingdom
Beatson West of Scotland Cancer Centre
Glasgow, Scotland, United Kingdom
Raigmore Hospital
Inverness, Scotland, United Kingdom
Perth Royal Infirmary
Perth, Scotland, United Kingdom
Ysbyty Gwynedd
Bangor, Wales, United Kingdom
Velindre Cancer Center at Velindre Hospital
Cardiff, Wales, United Kingdom
Glan Clwyd Hospital
Rhyl, Denbighshire, Wales, United Kingdom
Wrexham Maelor Hospital
Wrexham, Wales, United Kingdom
Edith Cavell Hospital
Peterborough, , United Kingdom
Countries
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References
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Mukherjee S, Hurt CN, Bridgewater J, Falk S, Cummins S, Wasan H, Crosby T, Jephcott C, Roy R, Radhakrishna G, McDonald A, Ray R, Joseph G, Staffurth J, Abrams RA, Griffiths G, Maughan T. Gemcitabine-based or capecitabine-based chemoradiotherapy for locally advanced pancreatic cancer (SCALOP): a multicentre, randomised, phase 2 trial. Lancet Oncol. 2013 Apr;14(4):317-26. doi: 10.1016/S1470-2045(13)70021-4. Epub 2013 Mar 6.
Fokas E, Spezi E, Patel N, Hurt C, Nixon L, Chu KY, Staffurth J, Abrams R, Mukherjee S. Comparison of investigator-delineated gross tumour volumes and quality assurance in pancreatic cancer: Analysis of the on-trial cases for the SCALOP trial. Radiother Oncol. 2016 Aug;120(2):212-6. doi: 10.1016/j.radonc.2016.07.002. Epub 2016 Aug 3.
Fokas E, Clifford C, Spezi E, Joseph G, Branagan J, Hurt C, Nixon L, Abrams R, Staffurth J, Mukherjee S. Comparison of investigator-delineated gross tumor volumes and quality assurance in pancreatic cancer: Analysis of the pretrial benchmark case for the SCALOP trial. Radiother Oncol. 2015 Dec;117(3):432-7. doi: 10.1016/j.radonc.2015.08.026. Epub 2015 Aug 29.
Other Identifiers
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WCTU-SCALOP
Identifier Type: -
Identifier Source: secondary_id
EUDRACT-2008-001394-15
Identifier Type: -
Identifier Source: secondary_id
ISRCTN-96169987
Identifier Type: -
Identifier Source: secondary_id
WCTU-SPON-415-07
Identifier Type: -
Identifier Source: secondary_id
CRUK-07/040
Identifier Type: -
Identifier Source: secondary_id
EU-21114
Identifier Type: -
Identifier Source: secondary_id
CDR0000660755
Identifier Type: -
Identifier Source: org_study_id
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