NCT Number: NCT00002689
Radiation Therapy Plus Chemotherapy in Treating Patients With Pancreatic Cancer
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. Radiation therapy combined with chemotherapy may kill more tumor cells.
PURPOSE: Phase II trial to study the effectiveness of brachytherapy followed by external-beam radiation therapy plus chemotherapy in treating patients who have pancreatic cancer that cannot be removed surgically.
Looking for future studies?
Notify MeKey information
Conditions
Age range
18 year and older
Sex eligibility
All sexes
Study type
Interventional
Phase
Phase 2
Primary location
Northside Hospital Cancer Center, Atlanta, Georgia, United States
About this study
OBJECTIVES:
- Determine the response/remission rate, survival, and degree of local control from interstitial colloidal phosphorus P32 followed by external beam radiotherapy and chemotherapy in patients with unresectable pancreatic cancer.
OUTLINE: Patients are stratified according to prior therapy (yes vs no).
Patients receive dexamethasone intratumorally, then macroaggregated albumin and interstitial phosphorus P32 intratumorally. Most patients receive a second course of this brachytherapy.
Patients then proceed to chemoradiotherapy beginning 7-14 days after brachytherapy. Radiotherapy is administered 5 days a week for 6.4 weeks. Fluorouracil IV is administered every other day for 4 doses during weeks 1 and 2.
Patients are followed monthly for 1 year then every 3 months thereafter.
PROJECTED ACCRUAL: A total of 48 patients will be accrued for this study.
Who can participate
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
DISEASE CHARACTERISTICS:
- Histologically proven unresectable adenocarcinoma of the pancreas limited to the head, body, or tail of the pancreas
- Diameter no greater than 5 cm
- Volume no greater than 66 mL
- No ascites (with or without tumor cells)
- No endoscopically proven tumor penetration of duodenum or stomach
PATIENT CHARACTERISTICS:
Age:
- 18 and over
Performance status:
- Karnofsky 70-100%
Hematopoietic:
- WBC at least 3,000/mm3
- Platelet count at least 100,000/mm3
- Hemoglobin at least 9 g/dL (transfusion allowed)
Hepatic:
- No hepatic disease
- At least 50% uptake of technetium-sulfur colloid in normal liver if cirrhosis suspected
- No vascular occlusion of portal system
Renal:
- Creatinine no greater than 1.5 mg/dL
- BUN no greater than 25 mg/dL
Other:
- No Crohn's disease, ulcerative colitis, or other inflammatory bowel disease
- Not pregnant
PRIOR CONCURRENT THERAPY:
Biologic therapy:
- Not specified
Chemotherapy:
- If prior chemotherapy, test dose of colloidal phosphorous P32 administered prior to attempted treatment
Endocrine therapy:
- Not specified
Radiotherapy:
- No prior radiotherapy to pancreas, liver, or upper gastrointestinal tract
Surgery:
- No complete surgical resection
- No splenectomy
Treatment and study plan
Fluorouracil
DrugBrachytherapy
Radiationphosphorus P32
Radiationradiation therapy
RadiationPrimary outcomes
-
Response rate
-
Duration of remission
-
Survival
Secondary outcomes
-
Patterns of failure
Sponsors and collaborators
Lead sponsor
Center for Molecular Medicine
Other
Registry information
Official study title
Phase II Interstitial Colloidal 32P Integrated in The Treatment of Non-Resectable Pancreatic Cancer
Important dates
- Study start
- 1995
- Study completion
- 2007
- First posted
- Jan 27, 2003
- Registry last updated
- Jul 18, 2013
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
Related clinical trials
Published trials that share one or more normalized conditions with this study.
Support Through Remote Observation and Nutrition Guidance (STRONG) Program for Pancreatic Cancer Patients
NCT05675059
Digestive System Diseases, Digestive System Neoplasms
Tampa, Florida, United States
View Trial DetailsTrial of Ascorbic Acid (AA) + Nanoparticle Paclitaxel Protein Bound + Cisplatin + Gemcitabine (AA NABPLAGEM)
NCT03410030
Digestive System Diseases, Digestive System Neoplasms
Scottsdale, Arizona, United States
View Trial Details'OLAP' (OLAparib Regulatory Post-marketing Surveillance)
NCT04553926
Adnexal Diseases, Breast Cancer
Ansan, South Korea
View Trial DetailsA Phase I Trial of LY3143921 Hydrate in Solid Tumours
NCT03096054
Breast Cancer (Triple Negative Type), Breast Diseases
Belfast, United Kingdom
View Trial Details