Track topics on Twitter Track topics that are important to you
RATIONALE: Drugs used in chemotherapy, such as fluorouracil and gemcitabine, 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. Fluorouracil may make the tumor cells more sensitive to radiation therapy. Brachytherapy uses radioactive material, such as phosphorus P32, placed directly into or near a tumor to kill tumor cells. Combining chemotherapy and external-beam radiation therapy with brachytherapy may kill more tumor cells.
PURPOSE: This randomized clinical trial is studying fluorouracil, gemcitabine, external-beam radiation therapy, and brachytherapy using phosphorus P32 to see how well they work compared to fluorouracil, gemcitabine, and external-beam radiation therapy in treating patients with locally or regionally advanced unresectable adenocarcinoma of the pancreas (pancreatic cancer).
- Compare the survival of patients with locally or regionally advanced unresectable adenocarcinoma of the pancreas treated with fluorouracil, external beam radiotherapy, and gemcitabine with vs without brachytherapy with phosphorus P32 suspension.
- Compare time to disease progression, tumor response rate, and physical performance in patients treated with these regimens.
- Compare the safety and tolerability of these regimens in this patient population.
- Compare duration of response and time to treatment failure in patients treated with these regimens.
OUTLINE: This is a randomized study. Patients are randomized to 1 of 2 treatment arms.
- Arm I: Patients receive phosphorus P32 suspension percutaneously under CT guidance on day 0 and at months 1, 2, 6, 7, and 8. Patients receive fluorouracil IV continuously on days 1-5 of weeks 1-6. Patients concurrently undergo external beam radiotherapy 5 days a week on weeks 1-6. At the completion of radiotherapy, patients receive gemcitabine IV over 30 minutes once weekly for 7 weeks. After a 1-week rest, patients then receive gemcitabine IV over 30 minutes once weekly for 3 weeks. Treatment repeats every 28 days.
- Arm II: Patients receive fluorouracil and gemcitabine and undergo external beam radiotherapy as in arm I.
In both arms, treatment continues in the absence of disease progression or unacceptable toxicity.
Patients are followed every 3 months.
PROJECTED ACCRUAL: A total of 80 patients (40 per treatment arm) will be accrued for this study within 24-30 months.
Allocation: Randomized, Control: Active Control, Primary Purpose: Treatment
fluorouracil, gemcitabine hydrochloride, brachytherapy, phosphorus P32, radiation therapy
USF Physician's Group
Active, not recruiting
National Cancer Institute (NCI)
Published on BioPortfolio: 2014-08-27T03:54:31-0400
Gemcitabine Hydrochloride With or Without Erlotinib Hydrochloride Followed By the Same Chemotherapy Regimen With or Without Radiation Therapy and Capecitabine or Fluorouracil in Treating Patients With Pancreatic Cancer That Has Been Removed By Surgery
This randomized phase II-R/III trial studies gemcitabine hydrochloride with or without erlotinib hydrochloride followed by the same chemotherapy regimen with or without radiation therapy a...
This phase II trial studies how well combination chemotherapy, gemcitabine hydrochloride, and radiation therapy before surgery works in treating patients with borderline resectable pancrea...
The purpose of this study is to test a new treatment of pancreatic cancer that cannot be removed by surgery. This treatment is a Phase I dose escalation research study which will combine ...
RATIONALE: Stereotactic radiation therapy may be able to send x-rays directly to the tumor and cause less damage to normal tissue. Drugs, such as nelfinavir mesylate, may make tumor cells ...
RATIONALE: Drugs used in chemotherapy, such as gemcitabine, fluorouracil, and cisplatin, work in different ways to stop the growth of tumor cells, either by killing the cells or by stoppin...
The objectives of this study were to assess the feasibility of preoperative gemcitabine/nab-paclitaxel-based chemoradiation therapy (CRT) for patients with borderline resectable pancreatic cancer (BRP...
Fluorouracil plus cisplatin and radiation twice a day (FCT) is an established chemoradiation (CRT) regimen for selective bladder-sparing treatment of muscle-invasive bladder cancer. Gemcitabine and on...
The NAPOLI-1 study (NCT01494506) reported that liposomal irinotecan plus 5-fluorouracil and leucovorin (nal-IRI+5-FU/LV) improved overall survival vs 5-FU/LV with manageable toxicity in patients with ...
Gemcitabine is the cornerstone of pancreatic cancer treatment. Although effective in most patients, development of tumor resistance to gemcitabine can critically limit its efficacy. The mechanisms res...
We analyzed factors associated with rectal toxicity after iodine-125 prostate brachytherapy (BT) with or without external beam radiation therapy (EBRT).
Unstable isotopes of phosphorus that decay or disintegrate emitting radiation. P atoms with atomic weights 28-34 except 31 are radioactive phosphorus isotopes.
Preliminary cancer therapy (chemotherapy, radiation therapy, hormone/endocrine therapy, immunotherapy, hyperthermia, etc.) that precedes a necessary second modality of treatment.
Organs which might be damaged during exposure to a toxin or to some form of therapy. It most frequently refers to healthy organs located in the radiation field during radiation therapy.
Stable phosphorus atoms that have the same atomic number as the element phosphorus, but differ in atomic weight. P-31 is a stable phosphorus isotope.
Drugs used to protect against ionizing radiation. They are usually of interest for use in radiation therapy but have been considered for other, e.g. military, purposes.
In a clinical trial or interventional study, participants receive specific interventions according to the research plan or protocol created by the investigators. These interventions may be medical products, such as drugs or devices; procedures; or change...
Pancreatitis Acute pancreatitis is inflammation of the pancreas caused by the release of activated pancreatic enzymes. Common triggers are biliary tract disease and chronic heavy alcohol intake. Diagnosis is based on clinical presentation...