A Randomized Study of Neoadjuvant Chemoradiotherapy With or Without Intensification With the FOLFOXIRI Chemo-regimen for High-risk Locally Advanced Rectal Cancer

CCTU3 sites in 1 country72 target enrollmentSeptember 10, 2019

Overview

Pathologic complete response rate

Registry

clinicaltrials.gov

Start Date

September 10, 2019

End Date

December 31, 2027

Last Updated

5 months ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Sponsor

Responsible Party

Sponsor Investigator

Principal Investigator

CCTU

Comprehensive Cancer Trials Unit, Department of Clinical Oncology, The Chinese University of Hong Kong

Chinese University of Hong Kong

•Able to provide written informed consent
•Age \>= 18 years of either sex.
•ECOG performance status 0-1
•Measurable disease by RECIST 1.1 criteria.
•Histologically confirmed rectal adenocarcinoma (defined as either mid- or low rectal cancer that is located within 12 cm from the anal verge OR below the peritoneal reflection) that is previously untreated.
•'High risk' rectal cancer, or rectal cancers that are considered marginally perable where there is a significant risk of positive surgical margin:
•T3 or T4, and / or
•Tumour infiltrating perirectal fat and/ or mesorectal fascia, and / or Involvement of pelvic lymph nodes, and/or
•Tumour invading surrounding structures or peritoneum or vasculature.
•Adequate bone marrow, renal and hepatic function as defined by: absolute neutrophil count \>= 1.5 x 109/L, hemoglobin \>= 9 g/L, platelets \>= 100 x 109/L, serum creatinine level \< 1.5 x ULN (or calculated creatinine clearance \>=50 ml/min, whichever is worse), total bilirubin \<=1.5 x the upper limit of normal, alanine aminotransferase (ALT) \< 3 upper limit of normal.

•Known distant metastasis, even if the metastasis has been resected.
•History of another invasive malignancy within the last 5 years, except for treated basal cell carcinoma of the skin, cervical intraepithelial neoplasia, or breast DCIS.
•Upper rectal cancer that is located above the peritoneal reflection.
•Patients with synchronous colon and rectal cancers are not excluded as long as: (1) these tumors are considered as two separate primaries (i.e. not metastasis or a contiguous part of a large primary), (2) both tumors are not causing imminent obstruction; (3) pelvic radiotherapy is not considered a contraindication.
•Primary tumour associated with any one of the following features:Frank intestinal obstruction, or
•Endoscope unable to pass through the tumour's lumen plus worsening local obstructive symptoms. Note: Patients with such features should be assessed by the surgical team regarding stomal bypass prior to study enrolment. Such patients can still be considered for study enrolment after undergoing stomal bypass.
•Known hypersensitivity reaction to the study drugs (i.e. fluoropyrimidine, irinotecan, oxaliplatin)
•Known peripheral neuropathy of grade 2 or more in severity.\\ -Patients who have received an experimental anticancer therapy within the last 28 days.
•Previous pelvic radiotherapy
•Previous oxaliplatin or irinotecan for the treatment of colon or rectal cancer.