Clinical trial · Interventional
Gemcitabine and Radiation Therapy in Treating Patients With Locally Advanced Upper Gastrointestinal Cancer
Pilot Study of Gemcitabine and IORT/EBRT in Locally Advanced Upper Gastrointestinal Malignancies
- 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)
RATIONALE: Drugs used in chemotherapy, such as gemcitabine, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Radiation therapy uses high-energy x-rays to kill tumor cells. Giving chemotherapy together with radiation therapy may kill more tumor cells. PURPOSE: This phase I trial is studying the side effects and best dose of gemcitabine when given together with radiation therapy in treating patients with locally advanced upper gastrointestinal cancer.
Conditions
Conditions (5)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Extrahepatic Bile Duct Cancer | Malignant Extrahepatic Bile Duct Neoplasm | ALIAS | 0.90 |
| Gallbladder Cancer | Malignant Gallbladder Neoplasm | CURATED_EXACT | 0.92 |
| Gastric Cancer | Malignant Gastric Neoplasm | CURATED_BROADER | 0.80 |
| Pancreatic Cancer | Malignant Pancreatic Neoplasm | CURATED_EXACT | 0.92 |
| Small Intestine Cancer | Small Intestinal Carcinoma | ALIAS | 0.90 |
Interventions
Interventions (6)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| conventional surgery | Procedure | — | UNRESOLVED |
| gemcitabine hydrochloride | Drug | Gemcitabine | ALIAS |
| immunohistochemistry staining method | Other | — | UNRESOLVED |
| intraoperative radiation therapy | Radiation | — | UNRESOLVED |
| polymerase chain reaction | Genetic | — | UNRESOLVED |
| radiation therapy | Radiation | — | UNRESOLVED |
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (3)
- measure
- Feasibility
- measure
- Tolerance
- measure
- Measurement of biochemical parameters in tumors that may correlate with the effectiveness of therapy
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 70 Years
Show eligibility criteria text
DISEASE CHARACTERISTICS:
* Diagnosis of any of the following upper gastrointestinal malignancies:
* Localized pancreatic adenocarcinoma
* Stage I, II, or III disease
* Parapancreatic node involvement and locally recurrent disease allowed
* Locally advanced biliary, gallbladder, or ampullary adenocarcinoma
* Stage II, III, or locally recurrent disease
* Histologically confirmed locally advanced gastric adenocarcinoma
* T3, T4, or node positive OR locally recurrent disease
* Histologically confirmed locally advanced duodenal cancer
* Stage II or III disease
* Locally advanced, but unresectable cancers may be included on protocol if appropriate for intraoperative radiotherapy (IORT)
* Other histologies may be considered for this protocol except for lymphoma, sarcoma, or neuroendocrine tumors
* Patients with evidence of metastatic disease are eligible if there is significant local disease warranting surgery and IORT
PATIENT CHARACTERISTICS:
* Karnofsky performance status \> 60%
* Life expectancy \> 4 months
* Absolute neutrophil count \> 1,500/mm\^3
* Platelet count \> 100,000/mm\^3
* Serum creatinine \< 2.0 mg/dL
* ALT \< 3 x normal
* Bilirubin \< 2 x normal
* Must be able to give voluntary informed consent
* No severe intercurrent illness that would make the patient inappropriate for laparotomy or otherwise inappropriate for treatment on protocol
* Prior history of malignancy allowed
PRIOR CONCURRENT THERAPY:
* More than 4 weeks since prior chemotherapy (6 weeks for mitomycin C)
* Prior gemcitabine hydrochloride allowedReferences
Publications (0)
Data not yet available