A Phase I Trial of Gemcitabine and Radiation in Locally Advanced Unresectable Cancer of the Pancreas
NCT ID: NCT00001431
Last Updated: 2008-03-04
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
PHASE1
20 participants
INTERVENTIONAL
1995-02-28
2000-11-30
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Chemoradiotherapy With Gemcitabine/S-1 vs Gemcitabine/S-1 for Locally Advanced Pancreatic Cancer
NCT01430052
Gemcitabine Plus Radiation Therapy in Treating Patients With Pancreatic Cancer
NCT00003426
Gemcitabine Plus Radiation Therapy in Treating Patients With Pancreatic Cancer
NCT00003546
Gemcitabine, Herceptin and Radiation to Treat Cancer of the Pancreas
NCT00005926
Gemcitabine With or Without Radiation Therapy in Treating Patients With Pancreatic Cancer
NCT00057876
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
TREATMENT
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
gemcitabine
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
Histologically or cytologically proven unresectable adenocarcinoma of the pancreas or ampulla of Vater. Surgical consult at NCI confirming unresectability fulfills requirement.
Unresectable disease defined as tumor with: Gross involvement of regional nodes or direct extension to any of the following sites: Duodenum, Spleen, Bile duct , Colon, Peripancreatic tissue, Adjacent large vessels, Stomach.
Metastatic disease requiring local radiotherapy allowed. No CNS metastasis.
No lymphomas or neuroendocrine tumors.
No peritoneal carcinomatosis.
PRIOR/CONCURRENT THERAPY:
Biologic Therapy: More than 4 weeks since immunotherapy.
Chemotherapy:
No prior chemotherapy for newly diagnosed disease.
More than 4 weeks since chemotherapy for recurrent disease (6 weeks since nitrosoureas, mitomycin, or suramin).
Endocrine Therapy: More than 4 weeks since hormonal therapy.
Radiotherapy:
No prior radiotherapy for newly diagnosed disease.
No prior abdominal or pelvic radiotherapy.
More than 4 weeks since radiotherapy for recurrent disease. No prior radiotherapy for locally advanced disease after resection allowed.
Surgery:
Prior resection allowed.
Biliary decompression or gastric bypass allowed.
PATIENT CHARACTERISTICS:
Age: 18 and over.
Performance status: ECOG 0-2.
Hematopoietic:
ANC greater than 2,000/mm(3).
Platelets greater than 100,000/mm(3).
Hepatic: AST/ALT no greater than 2.5 times normal.
Renal:
Creatinine less than 1.5 mg/dL.
Creatinine clearance at least 60 mL/min,
Cardiovascular:
No myocardial infarction within 6 months.
No unstable angina.
No congestive heart failure (NYHA class III/IV).
OTHER:
HIV seronegative.
No medical or psychiatric contraindication to protocol therapy.
No concurrent malignancy other than: Skin cancer, Cervical carcinoma in situ.
No pregnant or nursing women.
Adequate contraception required of fertile patients.
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
National Cancer Institute (NCI)
NIH
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
National Cancer Institute (NCI)
Bethesda, Maryland, United States
Countries
Review the countries where the study has at least one active or historical site.
References
Explore related publications, articles, or registry entries linked to this study.
Morohoshi T, Held G, Kloppel G. Exocrine pancreatic tumours and their histological classification. A study based on 167 autopsy and 97 surgical cases. Histopathology. 1983 Sep;7(5):645-61. doi: 10.1111/j.1365-2559.1983.tb02277.x.
Rosenberg JM, Welch JP, Macaulay WP. Cancer of the head of the pancreas: an institutional review with emphasis on surgical therapy. J Surg Oncol. 1985 Mar;28(3):217-21. doi: 10.1002/jso.2930280315.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
95-C-0075
Identifier Type: -
Identifier Source: secondary_id
950075
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.