Back to resultsGemcitabine, Capecitabine, and Radiation Therapy in Treating Patients With Locally Advanced Pancreatic Cancer That Cannot Be Removed by Surgery (SCALOP)
Primary Purpose
Pancreatic Cancer
Status
Completed
Phase
Phase 2
Locations
United Kingdom
Study Type
Interventional
Intervention
capecitabine
gemcitabine hydrochloride
quality-of-life assessment
3-dimensional conformal radiation therapy
Sponsored by
About this trial
This is an interventional treatment trial for Pancreatic Cancer focused on measuring adenocarcinoma of the pancreas, stage II pancreatic cancer, stage III pancreatic cancer
Eligibility Criteria
DISEASE CHARACTERISTICS:
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
Sites / Locations
- Queen Elizabeth Hospital at University Hospital of Birmingham NHS Trust
- Bristol Haematology and Oncology Centre
- Addenbrooke's Hospital
- Queen Alexandra Hospital
- Castle Hill Hospital
- Diana Princess of Wales Hospital
- St. Luke's Cancer Centre at Royal Surrey County Hospital
- Leeds Cancer Centre at St. James's University Hospital
- Leicester Royal Infirmary
- Helen Rollason Cancer Care Centre at North Middlesex Hospital
- Royal Free Hospital
- Hammersmith Hospital
- Northampton General Hospital
- Scarborough General Hospital
- Cancer Research Centre at Weston Park Hospital
- Southampton General Hospital
- Musgrove Park Hospital
- Ninewells Hospital
- Beatson West of Scotland Cancer Centre
- Raigmore Hospital
- Perth Royal Infirmary
- Ysbyty Gwynedd
- Velindre Cancer Center at Velindre Hospital
- Glan Clwyd Hospital
- Wrexham Maelor Hospital
- Edith Cavell Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
Gemcitabine
chemoradiotherpay with capecitabine
Arm Description
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)
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)
Outcomes
Primary Outcome Measures
Progression-free survival at 39 weeks (from registration) according to RECIST criteria
Secondary Outcome Measures
Toxicity according to NCI CTCAE v.3.0
Quality of life as measured by questionnaires QLQ-C30 and PAN26 at baseline and at 17, 23, 26, 39, and 52 weeks
Overall survival at 52 weeks and time from registration to death by any cause
Objective disease response according to RECIST criteria
Progression-free survival (time to event) according to RECIST criteria
Radiotherapy quality assurance (adherence to protocol)
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01032057
Brief Title
Gemcitabine, Capecitabine, and Radiation Therapy in Treating Patients With Locally Advanced Pancreatic Cancer That Cannot Be Removed by Surgery
Acronym
SCALOP
Official Title
A Multi-Center Randomized Phase II Study of Induction Chemotherapy Followed by Gemcitabine or Capecitabine Based Chemoradiotherapy for Locally Advanced Non-Metastatic Pancreatic Cancer
Study Type
Interventional
2. Study Status
Record Verification Date
October 2018
Overall Recruitment Status
Completed
Study Start Date
July 2009 (undefined)
Primary Completion Date
January 2013 (Actual)
Study Completion Date
June 2013 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Lisette Nixon
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
RATIONALE: Drugs used in chemotherapy, such as gemcitabine and capecitabine, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Radiation therapy uses high-energy x-rays to kill tumor cells. Giving radiation therapy that uses a 3-dimensional image of the tumor to help focus thin beams of radiation directly on the tumor, and giving radiation therapy in higher doses over a shorter period of time, may kill more tumor cells and have fewer side effects. It is not yet known which regimen of chemotherapy given together with radiation therapy is more effective in treating pancreatic cancer.
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.
Detailed Description
OBJECTIVES:
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pancreatic Cancer
Keywords
adenocarcinoma of the pancreas, stage II pancreatic cancer, stage III pancreatic cancer
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
114 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Gemcitabine
Arm Type
Active Comparator
Arm Description
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)
Arm Title
chemoradiotherpay with capecitabine
Arm Type
Active Comparator
Arm Description
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)
Intervention Type
Drug
Intervention Name(s)
capecitabine
Intervention Type
Drug
Intervention Name(s)
gemcitabine hydrochloride
Intervention Type
Procedure
Intervention Name(s)
quality-of-life assessment
Intervention Type
Radiation
Intervention Name(s)
3-dimensional conformal radiation therapy
Primary Outcome Measure Information:
Title
Progression-free survival at 39 weeks (from registration) according to RECIST criteria
Time Frame
Assessed 39 weeks from registration
Secondary Outcome Measure Information:
Title
Toxicity according to NCI CTCAE v.3.0
Time Frame
Assessed throughout trial treatment and follow-up
Title
Quality of life as measured by questionnaires QLQ-C30 and PAN26 at baseline and at 17, 23, 26, 39, and 52 weeks
Time Frame
Assessed throughout trial treatment and follow-up
Title
Overall survival at 52 weeks and time from registration to death by any cause
Time Frame
Assessed 52 weeks post registration and during NHS flagging
Title
Objective disease response according to RECIST criteria
Time Frame
39 weeks post registration
Title
Progression-free survival (time to event) according to RECIST criteria
Time Frame
Assessed during NHS flagging at the end of the trial
Title
Radiotherapy quality assurance (adherence to protocol)
Time Frame
Upon completion of the trial
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
120 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
DISEASE CHARACTERISTICS:
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Somnath Mukherjee
Organizational Affiliation
Northampton General Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Queen Elizabeth Hospital at University Hospital of Birmingham NHS Trust
City
Birmingham
State/Province
England
ZIP/Postal Code
B15 2TH
Country
United Kingdom
Facility Name
Bristol Haematology and Oncology Centre
City
Bristol
State/Province
England
ZIP/Postal Code
BS2 8ED
Country
United Kingdom
Facility Name
Addenbrooke's Hospital
City
Cambridge
State/Province
England
ZIP/Postal Code
CB2 2QQ
Country
United Kingdom
Facility Name
Queen Alexandra Hospital
City
Cosham
State/Province
England
ZIP/Postal Code
PO6 3LY
Country
United Kingdom
Facility Name
Castle Hill Hospital
City
Cottingham
State/Province
England
ZIP/Postal Code
HU16 5JQ
Country
United Kingdom
Facility Name
Diana Princess of Wales Hospital
City
Grimsby
State/Province
England
ZIP/Postal Code
DN33 2BA
Country
United Kingdom
Facility Name
St. Luke's Cancer Centre at Royal Surrey County Hospital
City
Guildford
State/Province
England
ZIP/Postal Code
GU2 7XX
Country
United Kingdom
Facility Name
Leeds Cancer Centre at St. James's University Hospital
City
Leeds
State/Province
England
ZIP/Postal Code
LS9 7TF
Country
United Kingdom
Facility Name
Leicester Royal Infirmary
City
Leicester
State/Province
England
ZIP/Postal Code
LE1 5WW
Country
United Kingdom
Facility Name
Helen Rollason Cancer Care Centre at North Middlesex Hospital
City
London
State/Province
England
ZIP/Postal Code
N18 1QX
Country
United Kingdom
Facility Name
Royal Free Hospital
City
London
State/Province
England
ZIP/Postal Code
NW3 2QG
Country
United Kingdom
Facility Name
Hammersmith Hospital
City
London
State/Province
England
ZIP/Postal Code
W12 OHS
Country
United Kingdom
Facility Name
Northampton General Hospital
City
Northampton
State/Province
England
ZIP/Postal Code
NN1 5BD
Country
United Kingdom
Facility Name
Scarborough General Hospital
City
Scarborough
State/Province
England
ZIP/Postal Code
YO12 6QL
Country
United Kingdom
Facility Name
Cancer Research Centre at Weston Park Hospital
City
Sheffield
State/Province
England
ZIP/Postal Code
S10 2SJ
Country
United Kingdom
Facility Name
Southampton General Hospital
City
Southampton
State/Province
England
ZIP/Postal Code
SO16 6YD
Country
United Kingdom
Facility Name
Musgrove Park Hospital
City
Taunton
State/Province
England
ZIP/Postal Code
TA1 5DA
Country
United Kingdom
Facility Name
Ninewells Hospital
City
Dundee
State/Province
Scotland
ZIP/Postal Code
DD1 9SY
Country
United Kingdom
Facility Name
Beatson West of Scotland Cancer Centre
City
Glasgow
State/Province
Scotland
ZIP/Postal Code
G12 0YN
Country
United Kingdom
Facility Name
Raigmore Hospital
City
Inverness
State/Province
Scotland
ZIP/Postal Code
1V2 3UJ
Country
United Kingdom
Facility Name
Perth Royal Infirmary
City
Perth
State/Province
Scotland
ZIP/Postal Code
PH1 1NX
Country
United Kingdom
Facility Name
Ysbyty Gwynedd
City
Bangor
State/Province
Wales
ZIP/Postal Code
LL57 2PW
Country
United Kingdom
Facility Name
Velindre Cancer Center at Velindre Hospital
City
Cardiff
State/Province
Wales
ZIP/Postal Code
CF14 2TL
Country
United Kingdom
Facility Name
Glan Clwyd Hospital
City
Rhyl, Denbighshire
State/Province
Wales
ZIP/Postal Code
LL 18 5UJ
Country
United Kingdom
Facility Name
Wrexham Maelor Hospital
City
Wrexham
State/Province
Wales
ZIP/Postal Code
LL13 7TD
Country
United Kingdom
Facility Name
Edith Cavell Hospital
City
Peterborough
ZIP/Postal Code
PE3 9EZ
Country
United Kingdom
12. IPD Sharing Statement
Citations:
PubMed Identifier
23474363
Citation
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.
Results Reference
result
PubMed Identifier
27497804
Citation
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.
Results Reference
result
PubMed Identifier
26328939
Citation
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.
Results Reference
result
Learn more about this trial
Gemcitabine, Capecitabine, and Radiation Therapy in Treating Patients With Locally Advanced Pancreatic Cancer That Cannot Be Removed by Surgery
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