|
Home
Search
Study Topics
Glossary
|
![]() |
![]() |
|
![]() |
|
![]() |
|
![]() |
![]() |
![]() |
|
![]() |
![]() |
||||||||||||||||||||||||||||||||||||
| Sponsor: | M.D. Anderson Cancer Center |
|---|---|
| Information provided by: | 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: | Treatment, Randomized, Double Blind (Subject, Caregiver), Single Group Assignment, Safety/Efficacy Study |
| 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 2010 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
1: Active Comparator
Radiotherapy, Capecitabine, Curcumin
|
Drug: Curcumin
Curcumin 4 gm 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)
Drug: Capecitabine
Capecitabine will be given at 825 mg/m^2 by mouth twice a day only on days of radiation (Monday through Friday).
|
|
2: Placebo Comparator
Radiotherapy, Capecitabine, Placebo
|
Drug: Placebo
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)
Drug: Capecitabine
Capecitabine will be given at 825 mg/m^2 by mouth twice a day only on days of radiation (Monday through Friday).
|
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| Contact: Sunil Krishnan, MD | 713-563-2361 |
| United States, Texas | |
| UT MD Anderson Cancer Center | Recruiting |
| Houston, Texas, United States, 77030 | |
| Contact: Sunil Krishnan, MD 713-563-2361 | |
| Principal Investigator: Sunil Krishnan, MD | |
| Principal Investigator: | Sunil Krishnan, MD | UT MD Anderson Cancer Center |
More Information
| Responsible Party: | UT MD Anderson Cancer Center ( Sunil Krishnan MD/Assistant Professor ) |
| Study ID Numbers: | 2006-0644 |
| Study First Received: | September 2, 2008 |
| Last Updated: | October 2, 2009 |
| ClinicalTrials.gov Identifier: | NCT00745134 History of Changes |
| Health Authority: | United States: Food and Drug Administration |
|
Rectum Rectal Cancer Colon Cancer Curcumin Diferuloylmethane |
Capecitabine Radiation Therapy RT XRT Surgery for Rectal Cancer |
|
Antimetabolites Anti-Inflammatory Agents Antimetabolites, Antineoplastic Immunologic Factors Molecular Mechanisms of Pharmacological Action Gastrointestinal Diseases Rectal Neoplasms Antineoplastic Agents Physiological Effects of Drugs Rectal Diseases Neoplasms by Site Sensory System Agents Therapeutic Uses Anti-Inflammatory Agents, Non-Steroidal Analgesics |
Capecitabine Curcumin Digestive System Neoplasms Enzyme Inhibitors Intestinal Diseases Immunosuppressive Agents Intestinal Neoplasms Pharmacologic Actions Neoplasms Digestive System Diseases Analgesics, Non-Narcotic Fluorouracil Gastrointestinal Neoplasms Peripheral Nervous System Agents Antirheumatic Agents |