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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Lisette Nixon, Cardiff University
ClinicalTrials.gov Identifier:
NCT01032057
First received: December 13, 2009
Last updated: February 13, 2014
Last verified: February 2014
  Purpose

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.


Condition Intervention Phase
Pancreatic Cancer
Drug: capecitabine
Drug: gemcitabine hydrochloride
Procedure: quality-of-life assessment
Radiation: 3-dimensional conformal radiation therapy
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
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

Resource links provided by NLM:


Further study details as provided by Cardiff University:

Primary Outcome Measures:
  • Progression-free survival at 39 weeks (from registration) according to RECIST criteria [ Time Frame: Assessed 39 weeks from registration ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Toxicity according to NCI CTCAE v.3.0 [ Time Frame: Assessed throughout trial treatment and follow-up ] [ Designated as safety issue: Yes ]
  • 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 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • Objective disease response according to RECIST criteria [ Time Frame: 39 weeks post registration ] [ Designated as safety issue: No ]
  • Progression-free survival (time to event) according to RECIST criteria [ Time Frame: Assessed during NHS flagging at the end of the trial ] [ Designated as safety issue: No ]
  • Radiotherapy quality assurance (adherence to protocol) [ Time Frame: Upon completion of the trial ] [ Designated as safety issue: No ]

Enrollment: 114
Study Start Date: July 2009
Study Completion Date: June 2013
Primary Completion Date: January 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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: capecitabine Drug: gemcitabine hydrochloride Procedure: quality-of-life assessment 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: capecitabine Drug: gemcitabine hydrochloride Procedure: quality-of-life assessment Radiation: 3-dimensional conformal radiation therapy

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01032057

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

Additional Information:
No publications provided

Responsible Party: Lisette Nixon, Dr, Cardiff University
ClinicalTrials.gov Identifier: NCT01032057     History of Changes
Other Study ID Numbers: CDR0000660755, WCTU-SCALOP, EUDRACT-2008-001394-15, ISRCTN-96169987, WCTU-SPON-415-07, CRUK-07/040, EU-21114
Study First Received: December 13, 2009
Last Updated: February 13, 2014
Health Authority: Medicines and Healthcare Products Regulatory Agency UK:

Keywords provided by Cardiff University:
adenocarcinoma of the pancreas
stage II pancreatic cancer
stage III pancreatic cancer

Additional relevant MeSH terms:
Pancreatic Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Endocrine Gland Neoplasms
Digestive System Diseases
Pancreatic Diseases
Endocrine System Diseases
Gemcitabine
Capecitabine
Fluorouracil
Antimetabolites, Antineoplastic
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Antineoplastic Agents
Therapeutic Uses
Antiviral Agents
Anti-Infective Agents
Enzyme Inhibitors
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Radiation-Sensitizing Agents

ClinicalTrials.gov processed this record on July 26, 2014