Completed

A Phase II Trial of External Irradiation (50.4 GY) and Weekly Paclitaxel (Taxol) for Non-Metastatic, Unresectable Pancreatic Cancer

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What is being tested

paclitaxel

+ radiation therapy

DrugRadiation
Who is being recruted

Digestive System Diseases+5

+ Digestive System Neoplasms

+ Endocrine System Diseases

Over 18 Years
See all eligibility criteria
How is the trial designed

Treatment Study

Phase 2
Interventional
Study Start: November 1998
See protocol details

Summary

Principal SponsorRadiation Therapy Oncology Group
Last updated: November 13, 2013
Sourced from a government-validated database.Claim as a partner

Study start date: November 1, 1998

Actual date on which the first participant was enrolled.

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.

NCT00003591
Principal SponsorRadiation Therapy Oncology Group
Last updated: November 13, 2013
Sourced from a government-validated database.Claim as a partner

Protocol

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

122 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Treatment Study

These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.



Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria

Any sex

Biological sex of participants that are eligible to enroll.

Over 18 Years

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

Digestive System DiseasesDigestive System NeoplasmsEndocrine System DiseasesEndocrine Gland NeoplasmsNeoplasmsNeoplasms by SitePancreatic DiseasesPancreatic Neoplasms

Criteria

DISEASE CHARACTERISTICS: Histologically confirmed nonmetastatic, unresectable pancreatic adenocarcinoma No evidence of metastatic disease in the major viscera and no peritoneal seeding Residual disease after resection (R-1 or -2 micro- and macroscopic residual) eligible if measurable disease on the post operative CT or MRI scan Recurrent disease following radical surgery is eligible All malignant disease must be encompassable within a single irradiation field Must be a radiographically assessable disease CT with 5 mm cuts or spiral CT PATIENT CHARACTERISTICS: Age: 18 and over Performance status: Karnofsky 60-100% Life expectancy: Not specified Hematopoietic: Granulocyte count at least 1,800/mm3 Platelet count at least 100,000/mm3 Hepatic: Bilirubin no greater than 2 mg/dL Biliary system stented Renal: Creatinine less than 3.0 mg/dL OR Creatinine clearance at least 40 mL/min Other: If patients have biliary or gastroduodenal obstruction, they must have drainage prior to starting chemoradiation Oral intake of at least 1,500 calories per day No significant infection or other coexistent medical condition PRIOR CONCURRENT THERAPY: Biologic therapy: Not specified Chemotherapy: No prior paclitaxel At least 4 weeks since prior gemcitabine No other prior chemotherapy Endocrine therapy: Not specified Radiotherapy: No prior radiotherapy to the planned field Surgery: See Disease Characteristics

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Treatment Groups
Study Objectives

One single intervention group is designated in this study

This study does not include a placebo group 

Treatment Groups

Group I

Experimental
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.

Study Objectives

Primary Objectives

Secondary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 234 locations

Veterans Affairs Medical Center - Birmingham

Birmingham, United StatesOpen Veterans Affairs Medical Center - Birmingham in Google Maps

University of Alabama Comprehensive Cancer Center

Birmingham, United States

Huntsville Hospital System

Huntsville, United States

Urology Associates - Mobile AL

Mobile, United States
Completed234 Study Centers