TerminatedPhase 2

Radiation Therapy and Capecitabine With or Without Curcumin Before Surgery in Treating Patients With Rectal Cancer

Stopped: The trial was stopped early because there was only one patient with pCR among the first 15 patients randomized to the curcumin arm.

United States22 participantsStarted 2008-08-11

Plain-language summary

This randomized phase II trial studies how well radiation therapy and capecitabine with or without curcumin before surgery works in treating patients with rectal cancer. Drugs such as curcumin may make tumor cells more sensitive to radiation therapy. Drugs used in chemotherapy, such as capecitabine, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving chemotherapy with radiation therapy before surgery may make the tumor smaller and reduce the amount of normal tissue that needs to be removed. It is not yet known whether chemotherapy and radiation therapy is more effective with or without curcumin when given before surgery in patients with rectal cancer.

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * All patients must have clinical stage T3,4 N0,1,2 or T2N1,2 adenocarcinoma of the rectum; patients will be clinically staged using endorectal ultrasound, pelvic computed tomography (CT) or magnetic resonance imaging (MRI), and physical examination * Histology must be confirmed with review by the Department of Pathology at MD Anderson Cancer Center (MDACC) * All patients must have no distant metastatic disease in the liver, peritoneum, lungs, or paraaortic lymph nodes * Patients must have a performance status (Karnofsky scale) of 70% or greater * Absolute neutrophil count (ANC) \> 1200 cells/mm\^3 * Platelets \> 100,000/mm\^3 * Total serum bilirubin \< 2 mg/dl * Blood urea nitrogen (BUN) \< 30 mg/dl * Creatinine \< 1.5 mg/dl or creatinine clearance \> 50cc/min (estimated as calculated with Cockcroft-Gault equation) * Patients must have signed informed consent indicating that they are aware of the investigational nature of the study, and are aware that participation is voluntary; patients must also agree to refrain from use of additional herbal supplements during the course of the study * Patients will agree to continue contraception for 30 days from the date of the last study drug administration; sexually active males must practice contraception during the study * Postmenopausal woman must have been amenorrheic for at least 12 months to be considered of non-childbearing potential Exclusion Criteria: * Prior complete course up to 5 Gy of radiotherapy to…

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Number of Participants With Pathologic Complete Response (pCR) Rate

Timeframe: At time of surgery

Trial details

NCT IDNCT00745134

SponsorM.D. Anderson Cancer Center

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2022-11-11

Results submitted2023-05-26

View on ClinicalTrials.gov More Rectal Mucinous Adenocarcinoma trials