Gemcitabine, Capecitabine, and Radiation Therapy in Treating Patients With Locally Advanced Pancreatic Cancer That Cannot Be Removed by Surgery

NCT01032057 | Completed Phase 2 DMC

• 7 other identifiers: CDR0000660755WCTU-SCALOPEUDRACT-2008-001394-15ISRCTN-96169987WCTU-SPON-415-07CRUK-07/040EU-21114
• Study Type: interventional
• Target: 114
• Locations: 1 country
• Sites: 26

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.

Conditions

Pancreatic Cancer

Keywords

adenocarcinoma of the pancreas; stage II pancreatic cancer; stage III pancreatic cancer

Outcome Measures

Primary Outcomes (1)

• Progression-free survival at 39 weeks (from registration) according to RECIST criteria

  Assessed 39 weeks from registration

Secondary Outcomes (6)

• Toxicity according to NCI CTCAE v.3.0

  Assessed throughout trial treatment and follow-up

• Quality of life as measured by questionnaires QLQ-C30 and PAN26 at baseline and at 17, 23, 26, 39, and 52 weeks

  Assessed throughout trial treatment and follow-up

• Overall survival at 52 weeks and time from registration to death by any cause

  Assessed 52 weeks post registration and during NHS flagging

• Objective disease response according to RECIST criteria

  39 weeks post registration

• Progression-free survival (time to event) according to RECIST criteria

  Assessed during NHS flagging at the end of the trial

Study Arms (2)

Gemcitabine

ACTIVE COMPARATOR

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)

Drug: capecitabine; Drug: gemcitabine hydrochloride; Procedure: quality-of-life assessment; Radiation: 3-dimensional conformal radiation therapy

chemoradiotherpay with capecitabine

ACTIVE COMPARATOR

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)

Drug: capecitabine; Drug: gemcitabine hydrochloride; Procedure: quality-of-life assessment; Radiation: 3-dimensional conformal radiation therapy

Interventions

capecitabine DRUG

Gemcitabine; chemoradiotherpay with capecitabine

gemcitabine hydrochloride DRUG

Gemcitabine; chemoradiotherpay with capecitabine

quality-of-life assessment PROCEDURE

Gemcitabine; chemoradiotherpay with capecitabine

3-dimensional conformal radiation therapy RADIATION

Gemcitabine; chemoradiotherpay with capecitabine

Eligibility Criteria

• Age: 18 Years - 120 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• Lisette Nixon: lead

Study Sites (26)

Queen Elizabeth Hospital at University Hospital of Birmingham NHS Trust

Birmingham, England, B15 2TH, United Kingdom

Location

Bristol Haematology and Oncology Centre

Bristol, England, BS2 8ED, United Kingdom

Location

Addenbrooke's Hospital

Cambridge, England, CB2 2QQ, United Kingdom

Location

Queen Alexandra Hospital

Cosham, England, PO6 3LY, United Kingdom

Location

Castle Hill Hospital

Cottingham, England, HU16 5JQ, United Kingdom

Location

Diana Princess of Wales Hospital

Grimsby, England, DN33 2BA, United Kingdom

Location

St. Luke's Cancer Centre at Royal Surrey County Hospital

Guildford, England, GU2 7XX, United Kingdom

Location

Leeds Cancer Centre at St. James's University Hospital

Leeds, England, LS9 7TF, United Kingdom

Location

Leicester Royal Infirmary

Leicester, England, LE1 5WW, United Kingdom

Location

Helen Rollason Cancer Care Centre at North Middlesex Hospital

London, England, N18 1QX, United Kingdom

Location

Royal Free Hospital

London, England, NW3 2QG, United Kingdom

Location

Hammersmith Hospital

London, England, W12 OHS, United Kingdom

Location

Northampton General Hospital

Northampton, England, NN1 5BD, United Kingdom

Location

Scarborough General Hospital

Scarborough, England, YO12 6QL, United Kingdom

Location

Cancer Research Centre at Weston Park Hospital

Sheffield, England, S10 2SJ, United Kingdom

Location

Southampton General Hospital

Southampton, England, SO16 6YD, United Kingdom

Location

Musgrove Park Hospital

Taunton, England, TA1 5DA, United Kingdom

Location

Ninewells Hospital

Dundee, Scotland, DD1 9SY, United Kingdom

Location

Beatson West of Scotland Cancer Centre

Glasgow, Scotland, G12 0YN, United Kingdom

Location

Raigmore Hospital

Inverness, Scotland, 1V2 3UJ, United Kingdom

Location

Perth Royal Infirmary

Perth, Scotland, PH1 1NX, United Kingdom

Location

Ysbyty Gwynedd

Bangor, Wales, LL57 2PW, United Kingdom

Location

Velindre Cancer Center at Velindre Hospital

Cardiff, Wales, CF14 2TL, United Kingdom

Location

Glan Clwyd Hospital

Rhyl, Denbighshire, Wales, LL 18 5UJ, United Kingdom

Location

Wrexham Maelor Hospital

Wrexham, Wales, LL13 7TD, United Kingdom

Location

Edith Cavell Hospital

Peterborough, PE3 9EZ, United Kingdom

Location

Related Publications (3)

• 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: 23474363 RESULT

• 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: 27497804 RESULT

• 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.

  PMID: 26328939 RESULT

MeSH Terms

Conditions

Pancreatic Neoplasms

Interventions

Capecitabine; Gemcitabine; Radiotherapy, Conformal

Condition Hierarchy (Ancestors)

Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Endocrine Gland Neoplasms; Digestive System Diseases; Pancreatic Diseases; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Deoxycytidine; Cytidine; Pyrimidine Nucleosides; Pyrimidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Fluorouracil; Uracil; Pyrimidinones; Deoxyribonucleosides; Nucleosides; Nucleic Acids, Nucleotides, and Nucleosides; Radiotherapy, Computer-Assisted; Radiotherapy; Therapeutics

Study Officials

• Somnath Mukherjee

  Northampton General Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Dr

Study Record Dates

• First Submitted: December 13, 2009
• First Posted: December 15, 2009
• Study Start: July 1, 2009
• Primary Completion: January 1, 2013
• Study Completion: June 1, 2013
• Last Updated: October 26, 2018

Record last verified: 2018-10

Locations

GB (26)