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

October 25, 2018 updated by: Lisette Nixon

A Multi-Center Randomized Phase II Study of Induction Chemotherapy Followed by Gemcitabine or Capecitabine Based Chemoradiotherapy for Locally Advanced Non-Metastatic Pancreatic Cancer

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

114

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United Kingdom
      • Peterborough, United Kingdom, PE3 9EZ
        • Edith Cavell Hospital
    • England
      • Birmingham, England, United Kingdom, B15 2TH
        • Queen Elizabeth Hospital at University Hospital of Birmingham NHS Trust
      • Bristol, England, United Kingdom, BS2 8ED
        • Bristol Haematology and Oncology centre
      • Cambridge, England, United Kingdom, CB2 2QQ
        • Addenbrooke's Hospital
      • Cosham, England, United Kingdom, PO6 3LY
        • Queen Alexandra Hospital
      • Cottingham, England, United Kingdom, HU16 5JQ
        • Castle Hill Hospital
      • Grimsby, England, United Kingdom, DN33 2BA
        • Diana Princess of Wales Hospital
      • Guildford, England, United Kingdom, GU2 7XX
        • St. Luke's Cancer Centre at Royal Surrey County Hospital
      • Leeds, England, United Kingdom, LS9 7TF
        • Leeds Cancer Centre at St. James's University Hospital
      • Leicester, England, United Kingdom, LE1 5WW
        • Leicester Royal Infirmary
      • London, England, United Kingdom, NW3 2QG
        • Royal Free Hospital
      • London, England, United Kingdom, W12 OHS
        • Hammersmith Hospital
      • London, England, United Kingdom, N18 1QX
        • Helen Rollason Cancer Care Centre at North Middlesex Hospital
      • Northampton, England, United Kingdom, NN1 5BD
        • Northampton General Hospital
      • Scarborough, England, United Kingdom, YO12 6QL
        • Scarborough General Hospital
      • Sheffield, England, United Kingdom, S10 2SJ
        • Cancer Research Centre at Weston Park Hospital
      • Southampton, England, United Kingdom, SO16 6YD
        • Southampton General Hospital
      • Taunton, England, United Kingdom, TA1 5DA
        • Musgrove Park Hospital
    • Scotland
      • Dundee, Scotland, United Kingdom, DD1 9SY
        • Ninewells Hospital
      • Glasgow, Scotland, United Kingdom, G12 0YN
        • Beatson West of Scotland Cancer Centre
      • Inverness, Scotland, United Kingdom, 1V2 3UJ
        • Raigmore Hospital
      • Perth, Scotland, United Kingdom, PH1 1NX
        • Perth Royal Infirmary
    • Wales
      • Bangor, Wales, United Kingdom, LL57 2PW
        • Ysbyty Gwynedd
      • Cardiff, Wales, United Kingdom, CF14 2TL
        • Velindre Cancer Center at Velindre Hospital
      • Rhyl, Denbighshire, Wales, United Kingdom, LL 18 5UJ
        • Glan Clwyd Hospital
      • Wrexham, Wales, United Kingdom, LL13 7TD
        • Wrexham Maelor Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 120 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: 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)
Drug: gemcitabine hydrochloride
Procedure: quality-of-life assessment
Drug: capecitabine
Radiation: 3-dimensional conformal radiation therapy
Active Comparator: 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)
Drug: gemcitabine hydrochloride
Procedure: quality-of-life assessment
Drug: capecitabine
Radiation: 3-dimensional conformal radiation therapy

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Progression-free survival at 39 weeks (from registration) according to RECIST criteria
Time Frame: Assessed 39 weeks from registration
Assessed 39 weeks from registration

Secondary Outcome Measures

Outcome Measure
Time Frame
Toxicity according to NCI CTCAE v.3.0
Time Frame: Assessed throughout trial treatment and follow-up
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
Time Frame: Assessed throughout trial treatment and follow-up
Assessed throughout trial treatment and follow-up
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
Assessed 52 weeks post registration and during NHS flagging
Objective disease response according to RECIST criteria
Time Frame: 39 weeks post registration
39 weeks post registration
Progression-free survival (time to event) according to RECIST criteria
Time Frame: Assessed during NHS flagging at the end of the trial
Assessed during NHS flagging at the end of the trial
Radiotherapy quality assurance (adherence to protocol)
Time Frame: Upon completion of the trial
Upon completion of the trial

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Lisette Nixon

Investigators

  • Principal Investigator: Somnath Mukherjee, Northampton General Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2009

Primary Completion (Actual)

January 1, 2013

Study Completion (Actual)

June 1, 2013

Study Registration Dates

First Submitted

December 13, 2009

First Submitted That Met QC Criteria

December 13, 2009

First Posted (Estimate)

December 15, 2009

Study Record Updates

Last Update Posted (Actual)

October 26, 2018

Last Update Submitted That Met QC Criteria

October 25, 2018

Last Verified

October 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CDR0000660755
  • WCTU-SCALOP
  • EUDRACT-2008-001394-15
  • ISRCTN-96169987
  • WCTU-SPON-415-07
  • CRUK-07/040
  • EU-21114

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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