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Anti-metabolites

Pharmacological Study for Rectal Adenocarcinoma

Phase 2
Waitlist Available
Research Sponsored by M.D. Anderson Cancer Center
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 5 years
Awards & highlights

Study Summary

This trial is studying how well radiation therapy and capecitabine works in treating patients with rectal cancer, with or without the addition of curcumin.

Eligible Conditions
  • Rectal Adenocarcinoma
  • Rectal Cancer

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~5 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and 5 years for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Number of Participants With Pathologic Complete Response (pCR) Rate
Secondary outcome measures
Change in Curcumin Level in Serum
Change in Curcumin Level in Tumor Tissue
Number of Participants With Tumor Downstaging
+3 more

Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: Arm I (curcumin)Experimental Treatment6 Interventions
Patients undergo radiation therapy 5 days a week for a total of 28 fractions. Patients also receive capecitabine PO BID on the days of radiation therapy and curcumin PO BID in weeks 1-11.5.
Group II: Arm II (placebo)Active Control6 Interventions
Patients undergo radiation therapy and receive capecitabine as in Arm I. Patients also receive placebo PO BID in weeks 1-11.5.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Capecitabine
2013
Completed Phase 3
~3420
Curcumin
2017
Completed Phase 4
~1050
Radiation Therapy
2017
Completed Phase 3
~7250

Find a Location

Who is running the clinical trial?

M.D. Anderson Cancer CenterLead Sponsor
2,973 Previous Clinical Trials
1,789,324 Total Patients Enrolled
4 Trials studying Rectal Adenocarcinoma
1,312 Patients Enrolled for Rectal Adenocarcinoma
National Cancer Institute (NCI)NIH
13,665 Previous Clinical Trials
40,925,832 Total Patients Enrolled
15 Trials studying Rectal Adenocarcinoma
1,152 Patients Enrolled for Rectal Adenocarcinoma
Jillian R. Gunther, PHDStudy ChairM.D. Anderson Cancer Center

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Recent research and studies
clinicaltrials.govStudy
Radiation Therapy and Capecitabine With or Without Curcumin Before Surgery in Treating Patients With Rectal Cancer
2008. "Radiation Therapy and Capecitabine With or Without Curcumin Before Surgery in Treating Patients With Rectal Cancer". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT00745134.
~1 spots leftby Apr 2025
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