NCT00243854
Completed
Phase 1
Pilot Study Using Neoadjuvant Chemo-Radiotherapy and EGFR-tyrosine Kinase Inhibitor for Potentially Resectable Pancreatic Cancer
ConditionsPancreatic Cancer
DrugsTarceva
Overview
- Phase
- Phase 1
- Intervention
- Not specified
- Conditions
- Pancreatic Cancer
- Sponsor
- Indiana University School of Medicine
- Enrollment
- 8
- Locations
- 1
- Primary Endpoint
- To determine if giving chemotherapy, radiation, and Tarceva,(EGFR-tyrosine kinase inhibitor)will have side effects that will prevent surgery following this therapy
- Status
- Completed
- Last Updated
- 12 years ago
Overview
Brief Summary
To determine the feasibility and toxicity of neoadjuvant hypofractioned radiotherapy concurrently with weekly gemcitabine and an EGFR tyrosine-kinase inhibitor (OSI-774, Tarceva) in the treatment of patients with resectable pancreatic cancer.
Detailed Description
To determine the feasibility and toxicity of neoadjuvant hypofractioned radiotherapy concurrently with weekly gemcitabine and an EGFR tyrosine-kinase inhibitor (OSI-774, Tarceva) in the treatment of patients with resectable pancreatic cancer.
Investigators
Eligibility Criteria
Inclusion Criteria
- •pathologically confirmed adenocarcinoma of the pancreas
- •resectable disease
- •tumor \</= 6cm diameter
- •ECOG performance 0-1
- •Organ system fxn: granulocytes (\>/=1800/uL); plt ct \>/=100K; bili\</=2mg; liver enzymes \<2.5ULN; crt \</=1.5;
- •Normal CXR
- •Negative pregnancy test
Exclusion Criteria
- •metastatic disease or peritoneal seeding based on cross-sectional imaging
- •previous irradiation to the planned field
- •prior chemotherapy or immunotherapy
- •active infection
- •active PUD
Outcomes
Primary Outcomes
To determine if giving chemotherapy, radiation, and Tarceva,(EGFR-tyrosine kinase inhibitor)will have side effects that will prevent surgery following this therapy
Time Frame: Surgery - No later than 6 weeks from the completion of Neoadjuvant Therapy
Study Sites (1)
Loading locations...
Similar Trials
Not Yet Recruiting
Phase 2
Neoadjuvant Moderately Hypofractionated Radiotherapy Combined with Chemotherapy and Immunotherapy for High-risk LARCRectal CancerNCT06599827Shanghai Zhongshan Hospital54
Completed
N/A
Feasibility study of neoadjuvant chemoradiotherapy using Intensity Modulated Radiation Therapy (IMRT) with Docetaxel, CDDP and 5-Fluorouracil (DCF) for cervical esophageal cancer.cervical esophageal cancerJPRN-UMIN000018241Gunma University Hospital6
Recruiting
Phase 2
Hypofractionated Radiotherapy Followed by Surgical Resection in the Treatment of Soft Tissue SarcomasSoft Tissue SarcomasNCT04506008Vanderbilt-Ingram Cancer Center40
Active, Not Recruiting
N/A
NCRT Combined With Sequential Perioperative PD-1 Inhibitor for LAESCCEsophageal Squamous Cell Carcinoma (ESCC)NCT06762158RenJi Hospital50
Recruiting
Phase 2
A Series of Neoadjuvant Chemoradiotherapy Combined With Immunotherapy for Locally Advanced Rectal CancerLocally Advanced Rectal CarcinomaNCT06312982Beijing Friendship Hospital375