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

Phase 2

Completed

• Conditions: Pancreatic Cancer
• Interventions: Drug: capecitabine; Drug: gemcitabine hydrochloride; Procedure: quality-of-life assessment; Radiation: 3-dimensional conformal radiation therapy

• Registration Number: NCT01032057
• Lead Sponsor: Lisette Nixon

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.

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study Start: 2009-07
• Study First Submitted: 2009-12-13
• Study First Submitted QC: 2009-12-13
• Study First Posted: 2009-12-15
• Primary Completion: 2013-01
• Study Completion: 2013-06
• Status Verified: 2018-10
• Last Update Submitted: 2018-10-25
• Last Update Posted: 2018-10-26

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 114

Inclusion Criteria

Not provided

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Exclusion Criteria

Not provided

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Gemcitabine	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 gemcitabine 300mg/m2 weekly (IV) + 50.4Gy radiation over five and half weeks (1.8Gy per fraction, Monday-Friday)
Gemcitabine	3-dimensional conformal radiation therapy	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)
Gemcitabine	gemcitabine hydrochloride	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)
Gemcitabine	quality-of-life assessment	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)
chemoradiotherpay with capecitabine	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)
chemoradiotherpay with capecitabine	gemcitabine hydrochloride	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)
chemoradiotherpay with capecitabine	quality-of-life assessment	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)
chemoradiotherpay with capecitabine	3-dimensional conformal radiation therapy	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)

Primary Outcome Measures

Name	Time	Method
Progression-free survival at 39 weeks (from registration) according to RECIST criteria	Assessed 39 weeks from registration

Secondary Outcome Measures

Name	Time	Method
Objective disease response according to RECIST criteria	39 weeks post registration
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
Progression-free survival (time to event) according to RECIST criteria	Assessed during NHS flagging at the end of the trial
Radiotherapy quality assurance (adherence to protocol)	Upon completion of the trial

Trial Locations

Locations (26)

Glan Clwyd Hospital; 🇬🇧 Rhyl, Denbighshire, Wales, United Kingdom

Musgrove Park Hospital; 🇬🇧 Taunton, England, United Kingdom

Velindre Cancer Center at Velindre Hospital; 🇬🇧 Cardiff, Wales, United Kingdom

Queen Elizabeth Hospital at University Hospital of Birmingham NHS Trust; 🇬🇧 Birmingham, England, United Kingdom

Helen Rollason Cancer Care Centre at North Middlesex Hospital; 🇬🇧 London, England, United Kingdom

Bristol Haematology and Oncology Centre; 🇬🇧 Bristol, England, United Kingdom

Addenbrooke's Hospital; 🇬🇧 Cambridge, England, United Kingdom

Southampton General Hospital; 🇬🇧 Southampton, England, United Kingdom

Cancer Research Centre at Weston Park Hospital; 🇬🇧 Sheffield, England, United Kingdom

Queen Alexandra Hospital; 🇬🇧 Cosham, England, United Kingdom

Beatson West of Scotland Cancer Centre; 🇬🇧 Glasgow, Scotland, United Kingdom

Leeds Cancer Centre at St. James's University Hospital; 🇬🇧 Leeds, England, United Kingdom

Ninewells Hospital; 🇬🇧 Dundee, Scotland, United Kingdom

Wrexham Maelor Hospital; 🇬🇧 Wrexham, Wales, United Kingdom

Perth Royal Infirmary; 🇬🇧 Perth, Scotland, United Kingdom

Ysbyty Gwynedd; 🇬🇧 Bangor, Wales, United Kingdom

Edith Cavell Hospital; 🇬🇧 Peterborough, United Kingdom

Hammersmith Hospital; 🇬🇧 London, England, United Kingdom

Scarborough General Hospital; 🇬🇧 Scarborough, England, United Kingdom

Raigmore Hospital; 🇬🇧 Inverness, Scotland, United Kingdom

Royal Free Hospital; 🇬🇧 London, England, United Kingdom

St. Luke's Cancer Centre at Royal Surrey County Hospital; 🇬🇧 Guildford, England, United Kingdom

Diana Princess of Wales Hospital; 🇬🇧 Grimsby, England, United Kingdom

Leicester Royal Infirmary; 🇬🇧 Leicester, England, United Kingdom

Northampton General Hospital; 🇬🇧 Northampton, England, United Kingdom

Castle Hill Hospital; 🇬🇧 Cottingham, England, United Kingdom