A randomised, placebo‑controlled Phase II trial of simvastatin in addition to standard chemotherapy and radiation in preoperative treatment for rectal cancer (AGITG and CTC study).

See ANZCTR for full trial details >

 

Trial Summary:

Rectal cancer is often treated by chemotherapy and radiation before surgery but if the cancer responds poorly many patients relapse. Retrospective studies show better cancer responses and fewer side effects in patients taking a statin drug (for cholesterol) during radiation. This study with 222 Australasian patients will test if taking a statin for 3 months (during combined chemotherapy and radiation then for another 6 weeks) improves the rate of good tumour response and reduces side effects of this treatment.

Supported By:

AGITG

Eligibility:

Patients aged >18 years with biopsy‑proven rectal adenocarcinoma (or high‑grade dysplasia on biopsy with radiological evidence of invasive tumour) planned for concurrent long‑course pCRT using fluoropyrimidine‑based chemotherapy

Registration ID:

ACTRN12617001087347

Participation:

NSW and SA, Australia and New Zealand

Australian Lead Group:

AGITG

Status:

Open

Chairs:

Michael Jameson and Stephen Ackland

Activation Date:

13.04.2018

Contact:

spar.study@sydney.edu.au