745134
Last Update Posted: 2023-09-28
Recruiting has ended
All Genders accepted | 18 Years + |
22 Estimated Participants | No Expanded Access |
Interventional Study | Does not accept healthy volunteers |
Radiation Therapy and Capecitabine With or Without Curcumin Before Surgery in Treating Patients With Rectal Cancer
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.
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.
Eligibility
Relevant 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
If you aren't sure if you meet the criteria above speak to your healthcare professional. Criteria may be updated but not reflected here, do not hesitate to contact the study if you think are close to fitting criteria.
locations
Data sourced from ClinicalTrials.gov