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Sponsored by: |
M.D. Anderson Cancer Center |
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Information provided by: | M.D. Anderson Cancer Center |
ClinicalTrials.gov Identifier: | NCT00254436 |
To demonstrate the effectiveness of epoetin alfa on reduction in red blood cell tranfusions in gastric and rectal cancer patients undergoing preoperative chemoradiation therapy followed by surgery.
Condition | Intervention | Phase |
---|---|---|
Gastrointestinal Cancer Rectal Cancer |
Drug: Procrit (epoetin alfa) |
Phase III |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double-Blind, Placebo Control, Factorial Assignment, Safety/Efficacy Study |
Official Title: | A Double-Blind, Randomized, Placebo-Controlled Study of the Efficacy and Safety of Epoetin Alfa Administered Weekly in Patients With Gastric or Rectal Cancers Undergoing Preoperative Chemoradiation Followed by Surgery |
Estimated Enrollment: | 184 |
Study Start Date: | December 2002 |
Estimated Study Completion Date: | December 2003 |
Anemia and fatigue are common problems in gastric and rectal cancer subjects at the completion of chemoradiation therapy and surgery. Results of several studies in cancer subjects suggest that treatment with epoetin alfa may be effective in maintaining hemoglobin levels, thereby reducing fatigue, decreasing transfusion requirement, and potentially improving quality of life.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
Exclusion Criteria:
United States, Texas | |
UT MDAnderson Cancer Center | |
Houston, Texas, United States, 77030 |
Principal Investigator: | Saroj Vadhan-Raj, M.D. | UT MDAnderson Cancer Center |
Study ID Numbers: | ID00-264 |
Study First Received: | November 14, 2005 |
Last Updated: | November 14, 2005 |
ClinicalTrials.gov Identifier: | NCT00254436 History of Changes |
Health Authority: | United States: Food and Drug Administration |
Epoetin Alfa Digestive System Neoplasms Rectal Neoplasms Gastrointestinal Diseases Hematinics Rectal Neoplasm Intestinal Diseases |
Rectal Diseases Intestinal Neoplasms Digestive System Diseases Rectal Cancer Gastrointestinal Neoplasms Colorectal Neoplasms |
Epoetin Alfa Digestive System Neoplasms Rectal Neoplasms Gastrointestinal Diseases Hematinics Hematologic Agents Intestinal Diseases Rectal Diseases |
Pharmacologic Actions Intestinal Neoplasms Neoplasms Neoplasms by Site Digestive System Diseases Therapeutic Uses Gastrointestinal Neoplasms Colorectal Neoplasms |