Recurrent Rectal Carcinoma Clinical Trial
Official title:
A Randomized Double Blinded Study of Curcumin With Pre-operative Capecitabine and Radiation Therapy Followed by Surgery for 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. ;
Status | Clinical Trial | Phase | |
---|---|---|---|
Terminated |
NCT01198535 -
Phase I Study of Cetuximab With RO4929097 in Metastatic Colorectal Cancer
|
Phase 1 | |
Completed |
NCT00068692 -
Comparison of Adjuvant Chemotherapy Regimens in Treating Stage II/III Rectal Cancer
|
Phase 3 | |
Recruiting |
NCT04213794 -
Heated Intra-peritoneal Chemotherapy With Doxorubicin and Cisplatin for Abdominal for Pelvic Tumors in Pediatric Patients
|
Early Phase 1 | |
Active, not recruiting |
NCT03365882 -
S1613, Trastuzumab and Pertuzumab or Cetuximab and Irinotecan Hydrochloride in Treating Patients With Locally Advanced or Metastatic HER2/Neu Amplified Colorectal Cancer That Cannot Be Removed by Surgery
|
Phase 2 | |
Completed |
NCT02393755 -
Nintedanib and Capecitabine in Treating Patients With Refractory Metastatic Colorectal Cancer
|
Phase 1/Phase 2 | |
Completed |
NCT01131234 -
Gamma-Secretase Inhibitor RO4929097 and Cediranib Maleate in Treating Patients With Advanced Solid Tumors
|
Phase 1 | |
Completed |
NCT01802320 -
Akt Inhibitor MK2206 in Treating Patients With Previously Treated Colon or Rectal Cancer That is Metastatic or Locally Advanced and Cannot Be Removed by Surgery
|
Phase 2 | |
Terminated |
NCT01729923 -
A Trial of Maintenance ADAPT Therapy With Capecitabine and Celecoxib in Patients With Metastatic Colorectal Cancer
|
Phase 2 | |
Completed |
NCT01254617 -
Lenalidomide and Cetuximab in Treating Patients With Advanced Colorectal Cancer or Head and Neck Cancer
|
Phase 1 | |
Completed |
NCT03297710 -
TAS-102 and Radiation Therapy in Treating Patients With Rectal Cancer That Is Locally Recurrent, Metastatic, or Cannot Be Removed by Surgery
|
Phase 1 | |
Completed |
NCT01383343 -
Sorafenib Tosylate, Bevacizumab, Irinotecan Hydrochloride, Leucovorin Calcium, and Fluorouracil in Treating Patients With Metastatic Colorectal Cancer
|
Phase 1 | |
Active, not recruiting |
NCT02465060 -
Targeted Therapy Directed by Genetic Testing in Treating Patients With Advanced Refractory Solid Tumors, Lymphomas, or Multiple Myeloma (The MATCH Screening Trial)
|
Phase 2 |