Clinical trial · Interventional
A Phase I Trial of Gemcitabine and Radiation in Locally Advanced Unresectable Cancer of the Pancreas
NCT00001431CI-TRIAL-00001238completedPhase 1ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
Radiotherapy plus Single-Agent Chemotherapy/Radiosensitization. Involved-field irradiation using 4-15 MV photons; plus Gemcitabine, NSC-613327.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Gastrointestinal Neoplasms | Digestive System Neoplasm | ALIAS | 0.90 |
| Pancreatic Neoplasms | Pancreatic Neoplasm | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| gemcitabine | Drug | Gemcitabine | ALIAS |
Eligibility
Eligibility (as posted)
- Sex
- All
Show eligibility criteria text
DISEASE CHARACTERISTICS: 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.
References
Publications (2)
- BACKGROUNDMorohoshi 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. PMID 6313514
- BACKGROUNDRosenberg 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. PMID 2579295