Ignite Creation Date:
2025-12-24 @ 6:40 PM
Ignite Modification Date:
2026-01-04 @ 1:46 PM
Study NCT ID:
NCT01032057
Status:
COMPLETED
Last Update Posted:
2018-10-26
First Post:
2009-12-13
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Gemcitabine, Capecitabine, and Radiation Therapy in Treating Patients With Locally Advanced Pancreatic Cancer That Cannot Be Removed by Surgery
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D010190', 'term': 'Pancreatic Neoplasms'}], 'ancestors': [{'id': 'D004067', 'term': 'Digestive System Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D004701', 'term': 'Endocrine Gland Neoplasms'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}, {'id': 'D010182', 'term': 'Pancreatic Diseases'}, {'id': 'D004700', 'term': 'Endocrine System Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000069287', 'term': 'Capecitabine'}, {'id': 'D000093542', 'term': 'Gemcitabine'}, {'id': 'D020266', 'term': 'Radiotherapy, Conformal'}], 'ancestors': [{'id': 'D003841', 'term': 'Deoxycytidine'}, {'id': 'D003562', 'term': 'Cytidine'}, {'id': 'D011741', 'term': 'Pyrimidine Nucleosides'}, {'id': 'D011743', 'term': 'Pyrimidines'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D005472', 'term': 'Fluorouracil'}, {'id': 'D014498', 'term': 'Uracil'}, {'id': 'D011744', 'term': 'Pyrimidinones'}, {'id': 'D003853', 'term': 'Deoxyribonucleosides'}, {'id': 'D009705', 'term': 'Nucleosides'}, {'id': 'D009706', 'term': 'Nucleic Acids, Nucleotides, and Nucleosides'}, {'id': 'D011881', 'term': 'Radiotherapy, Computer-Assisted'}, {'id': 'D011878', 'term': 'Radiotherapy'}, {'id': 'D013812', 'term': 'Therapeutics'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 114}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2009-07'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-10', 'completionDateStruct': {'date': '2013-06', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2018-10-25', 'studyFirstSubmitDate': '2009-12-13', 'studyFirstSubmitQcDate': '2009-12-13', 'lastUpdatePostDateStruct': {'date': '2018-10-26', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2009-12-15', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2013-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Progression-free survival at 39 weeks (from registration) according to RECIST criteria', 'timeFrame': 'Assessed 39 weeks from registration'}], 'secondaryOutcomes': [{'measure': 'Toxicity according to NCI CTCAE v.3.0', 'timeFrame': 'Assessed throughout trial treatment and follow-up'}, {'measure': 'Quality of life as measured by questionnaires QLQ-C30 and PAN26 at baseline and at 17, 23, 26, 39, and 52 weeks', 'timeFrame': 'Assessed throughout trial treatment and follow-up'}, {'measure': 'Overall survival at 52 weeks and time from registration to death by any cause', 'timeFrame': 'Assessed 52 weeks post registration and during NHS flagging'}, {'measure': 'Objective disease response according to RECIST criteria', 'timeFrame': '39 weeks post registration'}, {'measure': 'Progression-free survival (time to event) according to RECIST criteria', 'timeFrame': 'Assessed during NHS flagging at the end of the trial'}, {'measure': 'Radiotherapy quality assurance (adherence to protocol)', 'timeFrame': 'Upon completion of the trial'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['adenocarcinoma of the pancreas', 'stage II pancreatic cancer', 'stage III pancreatic cancer'], 'conditions': ['Pancreatic Cancer']}, 'referencesModule': {'references': [{'pmid': '23474363', 'type': 'RESULT', '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.'}, {'pmid': '27497804', 'type': 'RESULT', '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.'}, {'pmid': '26328939', 'type': 'RESULT', '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.'}]}, 'descriptionModule': {'briefSummary': '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.\n\nPURPOSE: 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.', 'detailedDescription': 'OBJECTIVES:\n\n* 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.\n* 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.\n* To determine how HRQL varies during treatment and follow up in both arms.\n\nOUTLINE: This is a multicenter study.\n\nAll 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.\n\n* Arm I:\n\n * 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.\n * 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.\n* Arm II:\n\n * 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.\n * 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.\n\nPatients complete quality-of-life questionnaires QLQ-C30 and PAN26 at baseline and at 17, 23, 26, 39, and 52 weeks.\n\nAfter completion of study treatment, patients are followed every 3 months.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '120 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'DISEASE CHARACTERISTICS:\n\n* Histologically or cytologically confirmed adenocarcinoma of the pancreas\n\n * Locally advanced, nonmetastatic, inoperable, or operable (but medically unfit for surgery) disease\n\n * Palliative bypass procedure allowed\n * Common bile duct stenting allowed\n* Primary pancreatic lesion ≤ 7 cm in diameter as measured by CT scan of the thorax and abdomen within 4 weeks prior to registration\n* No recurrent cancer following definitive pancreatic surgery\n\nPATIENT CHARACTERISTICS:\n\n* WHO performance status (PS) 0-2\n* Neutrophil count ≥ 1.5 x 10\\^9/L\n* Platelet count ≥ 100 x 10\\^9/L\n* Hemoglobin ≥ 10 g/dL\n* Serum bilirubin \\< 35 μmol/L (50 μmol/L allowed for patients who have had a recent biliary drain and whose bilirubin is descending)\n* AST/ALT ≤ 2.5 times upper limit of normal (ULN)\n* Alkaline phosphatase ≤ 5 times ULN\n* GFR \\> 50 mL/min\n* Not pregnant or nursing\n* Negative pregnancy test\n* Fertile patients must use effective contraception during and for 12 weeks after completion of study therapy\n* No evidence of severe uncontrolled systemic diseases including uncontrolled coronary artery disease\n* No myocardial infarction or stroke within the past 6 months\n* 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\n* No suspected DPD deficiency\n* No renal abnormalities (e.g., adult polycystic kidney disease, hydronephrosis, or ipsilateral single kidney)\n* Must meet the following additional criteria for randomization:\n\n * WHO PS 0-1\n * Loss of weight no greater than 10% of that at baseline\n\nPRIOR CONCURRENT THERAPY:\n\n* See Disease Characteristics\n* At least 4 weeks since prior and no concurrent sorivudine or analogues\n* No prior radiotherapy to the upper abdomen\n* No concurrent methotrexate\n* No concurrent allopurinol'}, 'identificationModule': {'nctId': 'NCT01032057', 'acronym': 'SCALOP', 'briefTitle': 'Gemcitabine, Capecitabine, and Radiation Therapy in Treating Patients With Locally Advanced Pancreatic Cancer That Cannot Be Removed by Surgery', 'organization': {'class': 'OTHER', 'fullName': 'Cardiff University'}, 'officialTitle': 'A Multi-Center Randomized Phase II Study of Induction Chemotherapy Followed by Gemcitabine or Capecitabine Based Chemoradiotherapy for Locally Advanced Non-Metastatic Pancreatic Cancer', 'orgStudyIdInfo': {'id': 'CDR0000660755'}, 'secondaryIdInfos': [{'id': 'WCTU-SCALOP'}, {'id': 'EUDRACT-2008-001394-15'}, {'id': 'ISRCTN-96169987'}, {'id': 'WCTU-SPON-415-07'}, {'id': 'CRUK-07/040'}, {'id': 'EU-21114'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Gemcitabine', '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)', 'interventionNames': ['Drug: capecitabine', 'Drug: gemcitabine hydrochloride', 'Procedure: quality-of-life assessment', 'Radiation: 3-dimensional conformal radiation therapy']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'chemoradiotherpay with capecitabine', '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)', 'interventionNames': ['Drug: capecitabine', 'Drug: gemcitabine hydrochloride', 'Procedure: quality-of-life assessment', 'Radiation: 3-dimensional conformal radiation therapy']}], 'interventions': [{'name': 'capecitabine', 'type': 'DRUG', 'armGroupLabels': ['Gemcitabine', 'chemoradiotherpay with capecitabine']}, {'name': 'gemcitabine hydrochloride', 'type': 'DRUG', 'armGroupLabels': ['Gemcitabine', 'chemoradiotherpay with capecitabine']}, {'name': 'quality-of-life assessment', 'type': 'PROCEDURE', 'armGroupLabels': ['Gemcitabine', 'chemoradiotherpay with capecitabine']}, {'name': '3-dimensional conformal radiation therapy', 'type': 'RADIATION', 'armGroupLabels': ['Gemcitabine', 'chemoradiotherpay with capecitabine']}]}, 'contactsLocationsModule': {'locations': [{'zip': 'B15 2TH', 'city': 'Birmingham', 'state': 'England', 'country': 'United Kingdom', 'facility': 'Queen Elizabeth Hospital at University Hospital of Birmingham NHS Trust', 'geoPoint': {'lat': 52.48142, 'lon': -1.89983}}, {'zip': 'BS2 8ED', 'city': 'Bristol', 'state': 'England', 'country': 'United Kingdom', 'facility': 'Bristol Haematology and Oncology Centre', 'geoPoint': {'lat': 51.45523, 'lon': -2.59665}}, {'zip': 'CB2 2QQ', 'city': 'Cambridge', 'state': 'England', 'country': 'United Kingdom', 'facility': "Addenbrooke's Hospital", 'geoPoint': {'lat': 52.2, 'lon': 0.11667}}, {'zip': 'PO6 3LY', 'city': 'Cosham', 'state': 'England', 'country': 'United Kingdom', 'facility': 'Queen Alexandra Hospital', 'geoPoint': {'lat': 50.84654, 'lon': -1.06344}}, {'zip': 'HU16 5JQ', 'city': 'Cottingham', 'state': 'England', 'country': 'United Kingdom', 'facility': 'Castle Hill Hospital', 'geoPoint': {'lat': 52.50243, 'lon': -0.7554}}, {'zip': 'DN33 2BA', 'city': 'Grimsby', 'state': 'England', 'country': 'United Kingdom', 'facility': 'Diana Princess of Wales Hospital', 'geoPoint': {'lat': 53.56539, 'lon': -0.07553}}, {'zip': 'GU2 7XX', 'city': 'Guildford', 'state': 'England', 'country': 'United Kingdom', 'facility': "St. Luke's Cancer Centre at Royal Surrey County Hospital", 'geoPoint': {'lat': 51.23536, 'lon': -0.57427}}, {'zip': 'LS9 7TF', 'city': 'Leeds', 'state': 'England', 'country': 'United Kingdom', 'facility': "Leeds Cancer Centre at St. James's University Hospital", 'geoPoint': {'lat': 53.79648, 'lon': -1.54785}}, {'zip': 'LE1 5WW', 'city': 'Leicester', 'state': 'England', 'country': 'United Kingdom', 'facility': 'Leicester Royal Infirmary', 'geoPoint': {'lat': 52.6386, 'lon': -1.13169}}, {'zip': 'N18 1QX', 'city': 'London', 'state': 'England', 'country': 'United Kingdom', 'facility': 'Helen Rollason Cancer Care Centre at North Middlesex Hospital', 'geoPoint': {'lat': 51.50853, 'lon': -0.12574}}, {'zip': 'NW3 2QG', 'city': 'London', 'state': 'England', 'country': 'United Kingdom', 'facility': 'Royal Free Hospital', 'geoPoint': {'lat': 51.50853, 'lon': -0.12574}}, {'zip': 'W12 OHS', 'city': 'London', 'state': 'England', 'country': 'United Kingdom', 'facility': 'Hammersmith Hospital', 'geoPoint': {'lat': 51.50853, 'lon': -0.12574}}, {'zip': 'NN1 5BD', 'city': 'Northampton', 'state': 'England', 'country': 'United Kingdom', 'facility': 'Northampton General Hospital', 'geoPoint': {'lat': 52.25, 'lon': -0.88333}}, {'zip': 'YO12 6QL', 'city': 'Scarborough', 'state': 'England', 'country': 'United Kingdom', 'facility': 'Scarborough General Hospital', 'geoPoint': {'lat': 54.27966, 'lon': -0.40443}}, {'zip': 'S10 2SJ', 'city': 'Sheffield', 'state': 'England', 'country': 'United Kingdom', 'facility': 'Cancer Research Centre at Weston Park Hospital', 'geoPoint': {'lat': 53.38297, 'lon': -1.4659}}, {'zip': 'SO16 6YD', 'city': 'Southampton', 'state': 'England', 'country': 'United Kingdom', 'facility': 'Southampton General Hospital', 'geoPoint': {'lat': 50.90395, 'lon': -1.40428}}, {'zip': 'TA1 5DA', 'city': 'Taunton', 'state': 'England', 'country': 'United Kingdom', 'facility': 'Musgrove Park Hospital', 'geoPoint': {'lat': 51.01494, 'lon': -3.10293}}, {'zip': 'DD1 9SY', 'city': 'Dundee', 'state': 'Scotland', 'country': 'United Kingdom', 'facility': 'Ninewells Hospital', 'geoPoint': {'lat': 56.46913, 'lon': -2.97489}}, {'zip': 'G12 0YN', 'city': 'Glasgow', 'state': 'Scotland', 'country': 'United Kingdom', 'facility': 'Beatson West of Scotland Cancer Centre', 'geoPoint': {'lat': 55.86515, 'lon': -4.25763}}, {'zip': '1V2 3UJ', 'city': 'Inverness', 'state': 'Scotland', 'country': 'United Kingdom', 'facility': 'Raigmore Hospital', 'geoPoint': {'lat': 57.47908, 'lon': -4.22398}}, {'zip': 'PH1 1NX', 'city': 'Perth', 'state': 'Scotland', 'country': 'United Kingdom', 'facility': 'Perth Royal Infirmary', 'geoPoint': {'lat': 56.39522, 'lon': -3.43139}}, {'zip': 'LL57 2PW', 'city': 'Bangor', 'state': 'Wales', 'country': 'United Kingdom', 'facility': 'Ysbyty Gwynedd', 'geoPoint': {'lat': 53.22752, 'lon': -4.12936}}, {'zip': 'CF14 2TL', 'city': 'Cardiff', 'state': 'Wales', 'country': 'United Kingdom', 'facility': 'Velindre Cancer Center at Velindre Hospital', 'geoPoint': {'lat': 51.48, 'lon': -3.18}}, {'zip': 'LL 18 5UJ', 'city': 'Rhyl, Denbighshire', 'state': 'Wales', 'country': 'United Kingdom', 'facility': 'Glan Clwyd Hospital', 'geoPoint': {'lat': 53.31929, 'lon': -3.49228}}, {'zip': 'LL13 7TD', 'city': 'Wrexham', 'state': 'Wales', 'country': 'United Kingdom', 'facility': 'Wrexham Maelor Hospital', 'geoPoint': {'lat': 53.04664, 'lon': -2.99132}}, {'zip': 'PE3 9EZ', 'city': 'Peterborough', 'country': 'United Kingdom', 'facility': 'Edith Cavell Hospital', 'geoPoint': {'lat': 52.57364, 'lon': -0.24777}}], 'overallOfficials': [{'name': 'Somnath Mukherjee', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Northampton General Hospital'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Lisette Nixon', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'Dr', 'investigatorFullName': 'Lisette Nixon', 'investigatorAffiliation': 'Cardiff University'}}}}