Regional Versus Systemic Chemotherapy in the Treatment of Unresectable Pancreatic Cancer
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT01665625|
Recruitment Status : Unknown
Verified August 2012 by Guohong Han, Fourth Military Medical University.
Recruitment status was: Not yet recruiting
First Posted : August 15, 2012
Last Update Posted : August 15, 2012
|Condition or disease||Intervention/treatment||Phase|
|Unresectable Pancreatic Cancer||Procedure: regional interventional chemotherapy group||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||90 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Prospective Randomized Trial of Regional Versus Systemic Continuous Gemcitabine Chemotherapy in the Treatment of Unresectable Pancreatic Cancer|
|Study Start Date :||August 2012|
|Estimated Primary Completion Date :||August 2015|
|Estimated Study Completion Date :||February 2016|
|Experimental: regional interventional chemotherapy group||
Procedure: regional interventional chemotherapy group
The patients in experimental group were monitored by X-ray imaging. A 0.038 super-sliding guide wire was inserted after successful puncture, and when site of the pancreatic carcinoma was reconfirmed by conventional angiography, a 5F cobra catheter was used to place the port-catheter drug delivery system in the celiac artery (pancreatic head) or the hepatic artery (pancreatic body and tail). Finally, the port-catheter was embedded under the left upper chest.
|No Intervention: systemic chemotherapy|
- overall surviva [ Time Frame: 36 months ]
- Clinical Benefit Rate [ Time Frame: 12 months ]
- The median progression-free survival PFS [ Time Frame: 12 months ]
- Drug Toxicity [ Time Frame: 18 months ]The grading standards of the World Health Organization for acute and subacute toxicity of anticancer drugs will be used to grade toxicity.
- surgical complications [ Time Frame: 18 months ]Major surgical complications included allergic reaction to the contrast agent, local hematoma, pneumothorax, puncture site bleeding, wound infection, delayed healing or cracking, port-catheter blockage, and necrosis of the tissue surrounding the port-catheter.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01665625
|Contact: Jun Tie, PH.D., MDemail@example.com|
|Xijing Hospital of Digestive Diseases, Fourth Military Medical University||Not yet recruiting|
|Xi'an, Shaanxi, China, 710032|
|Contact: GuoHong Han, MD 86-29-84775221 firstname.lastname@example.org|
|Sub-Investigator: Jun Tie, PH.D.,MD|
|Xijing Hospital of Digestive Diseases, Fourth Military Medical University|
|Xi`an, Shaanxi, China, 710032|
|Principal Investigator:||Guohong Han, MD||Xijing Hospital of Digestive Diseases, Fourth Military Medical University|