Gemcitabine With or Without Radiation Therapy in Treating Patients With Pancreatic Cancer - Study Results

Study Type:	Interventional
Study Design:	Allocation: Randomized; Endpoint Classification: Efficacy Study; Intervention Model: Parallel Assignment; Masking: Open Label; Primary Purpose: Treatment
Condition:	Pancreatic Cancer
Interventions:	Drug: Gemcitabine Radiation: radiation therapy

Participant Flow

Recruitment Details

Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
The study was activated on April 10,2003, and terminated on December 15, 2005 as a result of slow accrual. The final accrual of the study was 74 patients. This was an intergroup study and coordinated by Eastern Cooperative Oncology Group with 9 participating groups.

Pre-Assignment Details

Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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Reporting Groups

	Description
Gemcitabine	Induction: Patients will receive the first cycle of gemcitabine 1000 mg/m² intravenously once per week for 6 weeks followed by 1 week rest. Consolidation: Following the week of rest, treatment will resume with 1000 mg/m² administered intravenously once per week for 3 weeks, followed by 1 week rest, for 5 (4-week) cycles.
Gemcitabine + Radiation	Induction: Patients will receive gemcitabine 600 mg/m² intravenous infusion over 30-60 minutes once a week for 6 weeks while receiving radiation therapy. The first gemcitabine dose will be given on the first day of radiation therapy (prior to radiation), then weekly thereafter. All patients on Arm B will receive radiation therapy Monday through Friday (no radiation on Saturday or Sunday), weeks 1-6, with once/week gemcitabine. The radiation dose per fraction will be 180 cGy prescribed to the isocenter. The total dose of radiation will be 5040 cGy given in 28 fractions over 5 1/2 weeks. Consolidation: Additional cycles of gemcitabine will begin approximately 4 weeks after completion of radiation therapy.

Description

Gemcitabine

Induction: Patients will receive the first cycle of gemcitabine 1000 mg/m² intravenously once per week for 6 weeks followed by 1 week rest.

Consolidation: Following the week of rest, treatment will resume with 1000 mg/m² administered intravenously once per week for 3 weeks, followed by 1 week rest, for 5 (4-week) cycles.

Gemcitabine + Radiation

Induction: Patients will receive gemcitabine 600 mg/m² intravenous infusion over 30-60 minutes once a week for 6 weeks while receiving radiation therapy. The first gemcitabine dose will be given on the first day of radiation therapy (prior to radiation), then weekly thereafter. All patients on Arm B will receive radiation therapy Monday through Friday (no radiation on Saturday or Sunday), weeks 1-6, with once/week gemcitabine. The radiation dose per fraction will be 180 cGy prescribed to the isocenter. The total dose of radiation will be 5040 cGy given in 28 fractions over 5 1/2 weeks.

Consolidation: Additional cycles of gemcitabine will begin approximately 4 weeks after completion of radiation therapy.

Participant Flow: Overall Study

	Gemcitabine	Gemcitabine + Radiation
STARTED	38	36
Eligible	37	34
Began Protocol Therapy	35	34
Eligible and Treated	34	34
COMPLETED	9	9
NOT COMPLETED	29	27
Adverse Event	8	8
Death	2	1
Withdrawal by Subject	5	6
Lack of Efficacy	10	8
Ineligible	1	2
other reason	2	2
other complicating disease	1	0

Baseline Characteristics

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Reporting Groups

	Description
Gemcitabine	Induction: Patients will receive the first cycle of gemcitabine 1000 mg/m² intravenously once per week for 6 weeks followed by 1 week rest. Consolidation: Following the week of rest, treatment will resume with 1000 mg/m² administered intravenously once per week for 3 weeks, followed by 1 week rest, for 5 (4-week) cycles.
Gemcitabine + Radiation	Induction: Patients will receive gemcitabine 600 mg/m² intravenous infusion over 30-60 minutes once a week for 6 weeks while receiving radiation therapy. The first gemcitabine dose will be given on the first day of radiation therapy (prior to radiation), then weekly thereafter. All patients on Arm B will receive radiation therapy Monday through Friday (no radiation on Saturday or Sunday), weeks 1-6, with once/week gemcitabine. The radiation dose per fraction will be 180 cGy prescribed to the isocenter. The total dose of radiation will be 5040 cGy given in 28 fractions over 5 1/2 weeks. Consolidation: Additional cycles of gemcitabine will begin approximately 4 weeks after completion of radiation therapy.

Description

Gemcitabine

Induction: Patients will receive the first cycle of gemcitabine 1000 mg/m² intravenously once per week for 6 weeks followed by 1 week rest.

Consolidation: Following the week of rest, treatment will resume with 1000 mg/m² administered intravenously once per week for 3 weeks, followed by 1 week rest, for 5 (4-week) cycles.

Gemcitabine + Radiation

Induction: Patients will receive gemcitabine 600 mg/m² intravenous infusion over 30-60 minutes once a week for 6 weeks while receiving radiation therapy. The first gemcitabine dose will be given on the first day of radiation therapy (prior to radiation), then weekly thereafter. All patients on Arm B will receive radiation therapy Monday through Friday (no radiation on Saturday or Sunday), weeks 1-6, with once/week gemcitabine. The radiation dose per fraction will be 180 cGy prescribed to the isocenter. The total dose of radiation will be 5040 cGy given in 28 fractions over 5 1/2 weeks.

Consolidation: Additional cycles of gemcitabine will begin approximately 4 weeks after completion of radiation therapy.

Baseline Measures

	Gemcitabine	Gemcitabine + Radiation	Total
Number of Participants [units: participants]	37	34	71
Age [units: years] Mean ± Standard Deviation	67.0 ± 8.7	65.3 ± 10.3	66.2 ± 9.5
Gender [units: participants]
Female	19	15	34
Male	18	19	37
Region of Enrollment [units: participants]
United States	37	34	71

Outcome Measures

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1. Primary:

Overall Survival Time [ Time Frame: assessed every 3 months for 2 years, then every 6 months for year 3 ]

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2. Secondary:

Progression-free Survival Time [ Time Frame: assessed every 3 months for 2 years, then every 6 months for year 3 ]

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3. Secondary:

Overall Response [ Time Frame: assessed at week 8, and every 3 months for 2 years, then every 6 months for year 3 ]

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Serious Adverse Events

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Other Adverse Events

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More Information

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Certain Agreements:

Principal Investigators are NOT employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.

Limitations and Caveats

Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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Results Point of Contact:

Name/Title: Study Statistician
Organization: Eastern Cooperative Oncology Group (ECOG) Statistical Office
phone: 617-632-3012

Publications of Results:

Loehrer PJ, Powell ME, Cardenes HR, et al.: A randomized phase III study of gemcitabine in combination with radiation therapy versus gemcitabine alone in patients with localized, unresectable pancreatic cancer: E4201. [Abstract] J Clin Oncol 26 (Suppl 15): A-4506, 2008.

Responsible Party:	Robert Comis, M.D., ECOG Group Chair's Office
ClinicalTrials.gov Identifier:	NCT00057876 History of Changes
Other Study ID Numbers:	CDR0000278947, U10CA021115, E4201
Study First Received:	April 7, 2003
Results First Received:	February 28, 2011
Last Updated:	June 21, 2011
Health Authority:	United States: Federal Government