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| Sponsor: | M.D. Anderson Cancer Center |
|---|---|
| Information provided by (Responsible Party): | M.D. Anderson Cancer Center |
| ClinicalTrials.gov Identifier: | NCT00745134 |
Purpose
The goal of this clinical research study is to learn if combining a curcumin preparation with standard radiation therapy and chemotherapy (capecitabine) can help to shrink or slow the growth of rectal cancer. The safety of this combination and whether curcumin can help to decrease some of the side effects of standard radiotherapy and chemotherapy will also be studied.
| Condition | Intervention | Phase |
|---|---|---|
|
Rectal Cancer |
Drug: Curcumin Drug: Placebo Radiation: Radiotherapy Drug: Capecitabine |
Phase II |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Double Blind (Subject, Caregiver) Primary Purpose: Treatment |
| Official Title: | A Randomized Double Blinded Study of Curcumin With Pre-operative Capecitabine and Radiation Therapy Followed by Surgery for Rectal Cancer |
| Estimated Enrollment: | 45 |
| Study Start Date: | July 2008 |
| Estimated Primary Completion Date: | July 2013 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Active Comparator: 1
Radiotherapy, Capecitabine, Curcumin
|
Drug: Curcumin
4 gm tablets by mouth twice a day
Radiation: Radiotherapy
45 Gy once a day, for 5 days in a row for 5-6 weeks (up to 28 treatments in all)
Other Names:
Drug: Capecitabine
825 mg/m^2 by mouth twice a day only on days of radiation (Monday through Friday).
Other Name: Xeloda
|
|
Placebo Comparator: 2
Radiotherapy, Capecitabine, Placebo
|
Drug: Placebo
Tablets by mouth twice a day
Radiation: Radiotherapy
45 Gy once a day, for 5 days in a row for 5-6 weeks (up to 28 treatments in all)
Other Names:
Drug: Capecitabine
825 mg/m^2 by mouth twice a day only on days of radiation (Monday through Friday).
Other Name: Xeloda
|
Show Detailed Description
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations| United States, Texas | |
| UT MD Anderson Cancer Center | |
| Houston, Texas, United States, 77030 | |
| Principal Investigator: | Sunil Krishnan, MD | UT MD Anderson Cancer Center |
More Information
| Responsible Party: | M.D. Anderson Cancer Center |
| ClinicalTrials.gov Identifier: | NCT00745134 History of Changes |
| Other Study ID Numbers: | 2006-0644 |
| Study First Received: | September 2, 2008 |
| Last Updated: | November 15, 2011 |
| Health Authority: | United States: Food and Drug Administration |
|
Rectum Rectal Cancer Colon Cancer Curcumin Diferuloylmethane |
Capecitabine Radiation Therapy RT XRT Surgery for Rectal Cancer |
|
Rectal Neoplasms Colorectal Neoplasms Intestinal Neoplasms Gastrointestinal Neoplasms Digestive System Neoplasms Neoplasms by Site Neoplasms Digestive System Diseases Gastrointestinal Diseases Intestinal Diseases Rectal Diseases Curcumin Capecitabine Fluorouracil Anti-Inflammatory Agents, Non-Steroidal |
Analgesics, Non-Narcotic Analgesics Sensory System Agents Peripheral Nervous System Agents Physiological Effects of Drugs Pharmacologic Actions Anti-Inflammatory Agents Therapeutic Uses Antirheumatic Agents Antineoplastic Agents Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action Central Nervous System Agents Antimetabolites, Antineoplastic Antimetabolites |