Health Condition 1: K628- Other specified diseases of anus and rectum
Conditions
Interventions
Intervention1: Rosuvastatin in addition to Neo-adjuvant Chemoradiotherapy: Rosuvastatin is a 3rd generation statin has high potency and efficacy It owes remarkable potency and efficacy due to its fluo
Sponsors
Tata Memorial Hospital
Eligibility
Inclusion criteria
Inclusion criteria: 1.Age between 18 and 70 years 2.ECOG performance status 0 to 2 3.Histologic diagnosis of rectal adenocarcinoma 4.Clinical and radiological T3-4 N0 M0 or T (any) N + M0 5.Fit for receiving neoadjuvant chemoradiotherapy 6.Absence of colorectal synchronous Primary
Exclusion criteria
Exclusion criteria: 1.Patients with proven metastatic disease 2.History of Crohns disease or ulcerative colitis 3.Inherited polyposis syndromes 4.Ongoing statin or aspirin therapy for cardiovascular disease 5.Pregnant or nursing women 6.Patient not willing for informed consent 7.Comorbidities precluding statins and neo-adjuvant therapy including but not limited to Hepatitis, acute or chronic kidney disease •Hepatitis will be defined as sustained elevation of transaminases (two readings 5-7 days apart) >= 3 X upper limit of normal •Kidney disease will be defined as elevated creatinine levels above the upper limit of normal 8.Prior antineoplastic therapy 9.Patients already taking the following drugs: Cyclosporine, Gemfibrozil, Atazanavir/ritonavir, lopinavir/ritonavir, Tipranavir/ritonavir or simeprevir, Eltrombopag, Dronedarone, Itraconazole, Fluconazole or Ketoconazole, coumarin anticoagulants, lipid-lowering therapies: fibrates or lipid modifying doses (greater than or equal to 1 g/day) of niacin Aluminum and magnesium hydroxide combination antacid and Erythromycin
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To determine the impact of Rosuvastatin in improving pCR in patients with localized rectal cancer undergoing neoadjuvant chemoradiotherapy.Timepoint: Rosuvastatin week 2 and week 4 visit and at week 6 | — |
Secondary
| Measure | Time frame |
|---|---|
| The secondary efficacy endpoints are toxicity and 3 year DFS.Timepoint: 30 days after surgery | — |
Countries
India
Contacts
Public ContactDr Prachi Patil
Tata Memorial Hospital
Outcome results
None listed