Role of lipid lowering drug in the treatment of rectal cancers

Phase 2

• Conditions: Health Condition 1: K628- Other specified diseases of anus and rectum

• Registration Number: CTRI/2018/11/016459
• Lead Sponsor: Tata Memorial Hospital

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 24 November 2021

Recruitment & Eligibility

• Status: ot Yet Recruiting
• Sex: Not specified
• Target Recruitment: 0

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

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

Study & Design

• Study Type: Interventional
• Study Design: Not specified