NCT00745134

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

A Randomized Double Blinded Study of Curcumin With Pre-operative Capecitabine and Radiation Therapy Followed by Surgery for Rectal Cancer

• Status: Terminated
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 22 (actual)
• Sponsor: M.D. Anderson Cancer Center · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed description

PRIMARY OBJECTIVES: I. To evaluate the efficacy of a combination of capecitabine and radiation therapy with or without curcumin in locally advanced rectal cancer as assessed by pathological complete response rate. SECONDARY OBJECTIVES: I. To determine downstaging, local control, disease-free survival and overall survival rates. II. To determine serum and rectal tumor tissue pharmacology of curcumin and its metabolites in the above patients and its correlation with clinical response. III. To identify surrogate molecular markers for curcumin effects. IV. To correlate serum cytokine levels with quality of life in patients receiving this therapy. OUTLINE: Patients are randomized to 1 of 2 treatment arms. ARM I: Patients undergo radiation therapy 5 days a week for a total of 28 fractions. Patients also receive capecitabine orally (PO) twice daily (BID) on the days of radiation therapy and curcumin PO BID in weeks 1-11.5. ARM II: Patients undergo radiation therapy and receive capecitabine as in Arm I. Patients also receive placebo PO BID in weeks 1-11.5. After completion of study treatment, patients are followed up at 1 month.

Conditions

• Rectal Mucinous Adenocarcinoma
• Rectal Signet Ring Cell Adenocarcinoma
• Recurrent Rectal Carcinoma
• Stage IIA Rectal Cancer AJCC v7
• Stage IIB Rectal Cancer AJCC v7
• Stage IIC Rectal Cancer AJCC v7
• Stage IIIA Rectal Cancer AJCC v7
• Stage IIIB Rectal Cancer AJCC v7
• Stage IIIC Rectal Cancer AJCC v7

Interventions

Type	Name	Description
DRUG	Capecitabine	Given PO
DIETARY_SUPPLEMENT	Curcumin	Given PO
OTHER	Laboratory Biomarker Analysis	Correlative studies
OTHER	Pharmacological Study	Optional correlative studies
OTHER	Placebo	Given PO
OTHER	Quality-of-Life Assessment	Ancillary studies
RADIATION	Radiation Therapy	Undergo radiation therapy

Timeline

• Start date: 2008-08-11
• Primary completion: 2022-11-11
• Completion: 2022-11-11
• First posted: 2008-09-03
• Last updated: 2023-09-28
• Results posted: 2023-09-28

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study