Radiation Therapy Plus Paclitaxel in Treating Patients With Nonmetastatic, Unresectable Pancreatic Cancer
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|ClinicalTrials.gov Identifier: NCT00003591|
Recruitment Status : Completed
First Posted : September 13, 2004
Last Update Posted : November 13, 2013
RATIONALE: Radiation therapy uses high-energy x-rays to damage tumor cells. Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining radiation therapy with chemotherapy may kill more tumor cells.
PURPOSE: Phase II trial to study the effectiveness of radiation therapy plus paclitaxel in treating patients who have nonmetastatic, unresectable pancreatic cancer.
|Condition or disease||Intervention/treatment||Phase|
|Pancreatic Cancer||Drug: paclitaxel Radiation: radiation therapy||Phase 2|
OBJECTIVES: I. Determine the response rate of patients with nonmetastatic, unresectable pancreatic cancer receiving external beam irradiation and weekly paclitaxel. II. Determine the median survival after this treatment in these patients. III. Evaluate the acute and late treatment morbidity of paclitaxel in these patients. IV. Correlate p53 status with treatment response to this treatment in this patient population.
OUTLINE: This is a open label, multicenter study. Patients are highly recommended to undergo laparoscopic surgical staging prior to protocol to exclude peritoneal and hepatic metastases. Patients receive paclitaxel IV over 3 hours weekly for 6 weeks beginning on day 1 followed 1.5 hours later by external beam radiotherapy daily 5 days a week for 5.5 weeks beginning on day 1. All patients are restaged with an abdominal CT scan 6 weeks following completion of chemoradiotherapy. If there is marked response to treatment at this time, curative surgery may be attempted at the discretion of the attending surgeon. Patients are followed every 3 months for 1 year, every 4 months for the second year, every 6 months for years 3-5, and annually thereafter.
PROJECTED ACCRUAL: A total of 100 patients will be accrued into this study over 12 months.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||122 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Phase II Trial of External Irradiation (50.4 GY) and Weekly Paclitaxel (Taxol) for Non-Metastatic, Unresectable Pancreatic Cancer|
|Study Start Date :||November 1998|
|Primary Completion Date :||June 2001|
|Study Completion Date :||October 2005|
Experimental: Pacilitaxel + External Beam Radiation Therapy (PXRT)
Paclitaxel 50 mg/m2 given on Days 1, 8, 15, 22, 29 and 36. Radiation therapy: 50.4 Gy/28 fractions (1.8 Gy per fraction) once a day in 5.5 weeks.
|Drug: paclitaxel Radiation: radiation therapy|
- To determine the one-year and median survival rates after PXRTTo determine the one-year and median survival rates after paclitaxel and external beam radiation therapy (PXRT)
- To determine the response rate of PXRT in unresectable pancreatic cancer in a multi-center trial
- To evaluate the acute and late treatment morbidity of paclitaxel in a multi-institutional setting
- To correlate p53 status with treatment response to PXRT
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00003591
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|Study Chair:||Tyvin A. Rich, MD||University of Virginia|