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| Sponsor: | GenVec |
|---|---|
| Information provided by: | GenVec |
| ClinicalTrials.gov Identifier: | NCT00137878 |
Purpose
The purpose of this study is to determine if the addition of TNFerade™ to pre-operative chemoradiotherapy increases the number of pathologic complete responses when compared to pre-operative chemoradiotherapy alone as assessed following complete surgical resection of primary rectal cancer.
| Condition | Intervention | Phase |
|---|---|---|
|
Rectal Cancer |
Drug: TNFerade™ |
Phase II |
| Study Type: | Interventional |
| Study Design: | Treatment, Randomized |
| Official Title: | A Phase II Randomized Trial Comparing TNFerade™ Biologic With Capecitabine and Radiation Therapy Followed by Surgical Resection Versus Capecitabine and Radiation Therapy Followed by Surgical Resection for the Treatment of Rectal Cancer |
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations
More Information
| Study ID Numbers: | GV-001.007 |
| Study First Received: | August 26, 2005 |
| Last Updated: | May 20, 2009 |
| ClinicalTrials.gov Identifier: | NCT00137878 History of Changes |
| Health Authority: | United States: Food and Drug Administration |
|
Neoplasms Digestive System Diseases Neoplasms by Site Digestive System Neoplasms Gastrointestinal Diseases Rectal Neoplasms |
Gastrointestinal Neoplasms Intestinal Diseases Rectal Diseases Intestinal Neoplasms Colorectal Neoplasms |