Gemcitabine With or Without Radiation Therapy in Treating Patients With Pancreatic Cancer (NCT00057876) | Clinical Trial Compass
CompletedPhase 3
Gemcitabine With or Without Radiation Therapy in Treating Patients With Pancreatic Cancer
United States74 participantsStarted 2003-08-29
Plain-language summary
RATIONALE: Drugs used in chemotherapy work in different ways to stop tumor cells from dividing so they stop growing or die. Radiation therapy uses high-energy x-rays to damage tumor cells. It is not yet known whether gemcitabine is more effective with or without radiation therapy in treating pancreatic cancer.
PURPOSE: Randomized phase III trial to study the effectiveness of gemcitabine with or without radiation therapy in treating patients who have locally advanced, unresectable pancreatic cancer.
Who can participate
Age range18 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Histologically or cytologically confirmed adenocarcinoma of the pancreas
* Locally advanced or regional (encompassable within the same radiotherapy portals)
* Adenosquamous cancers are allowed
* Unresectable disease
* Measurable and/or non-measurable disease as determined by computed tomography (CT) scan or magnetic resonance imaging (MRI), which must be performed within 4 weeks prior to randomization.
* Age\>=18
* ECOG Performance status of 0-1
* Life expectancy \>= 12 weeks
* Adequate bone marrow reserve,liver and renal function within 2 weeks of randomization:
* Absolute granulocyte count at least 2,000/mm\^3
* Platelet count at least 100,000/mm\^3
* Bilirubin less than 3 mg/dL (unless secondary to biliary obstruction or cholangitis)
* Serum glutamic-oxaloacetic (AST) less than 5 times upper limit of normal (ULN)
* Albumin greater than 2.5 g/dL
* Creatinine no greater than 1.5 times ULN
* Fertile patients must use effective contraception
* Willing and able to attend follow-up visits
* Concurrent enrollment on protocol ECOG-E1Y03 allowed
* More than 4 weeks since prior investigational agents
Exclusion Criteria:
* Candidate for surgical excision based on local extent of disease (e.g., T3, N1, M0)
* Stage M1 disease
* Small cell, mucinous cystadenocarcinoma, islet cell or papillary cystic histology
* Pregnant or nursing
* Active infection within within 4 weeks of randomization
* Malignancy within the past 5 years except nonmelanoma s…
What they're measuring
1
Overall Survival Time
Timeframe: assessed every 3 months for 2 years, then every 6 months for year 3