Colon Neoadjuvant FOLFOXIRI Study

A Phase II Study of Neoadjuvant FOLFOXIRI Followed by Concurrent Capecitabine and Radiotherapy for High Risk Rectal Cancer

Objective tumour response rate to FOLFOXIRI to pre-operative therapy.

Study Overview

• Status: Active, not recruiting
• Conditions: Rectal Cancer
• Intervention / Treatment: Drug: Capecitabine; Drug: neoadjuvant FOLFOXIRI

• Study Type: Interventional
• Enrollment (Estimated): 40
• Phase: Phase 2

Contacts and Locations

Study Locations

• Hong Kong
  • Hong Kong, Hong Kong
    • Department of Clinical Oncology

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• 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 operable where there is a significant risk of positive surgical margin:

  • T3 (low-lying tumour at or below the levators) or T4, or
  • Tumour infiltrating perirectal fat, or
  • Any T-stage (T1-4) and node-positive tumour (invading surrounding structures or peritoneum)
• 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, calculated creatinine clearance >= 55 ml/min, total bilirubin =<1.5 x the upper limit of normal, alanine aminotransferase (ALT) =<2.5 upper limit of normal.

Exclusion Criteria:

• 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 non-invasive DCIS of the breast.
• Upper rectal cancer that is located above the peritoneal reflection.

• 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
• Patient with hip prosthesis
• Major surgery within the last 28 days. Exception: Any patient who underwent stomal bypass for obstructing primary tumour within the last 14 days are still eligible, as long as the patient has sufficiently recovered from the surgery at the investigator's discretion.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: neoadjuvant FOLFOXIRI	Drug: Capecitabine; Drug: neoadjuvant FOLFOXIRI

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Objective tumour response rate	2 years

Secondary Outcome Measures

Outcome Measure	Time Frame
Overall survival	5 years
Tumour regression grade	2 years
pathologic complete response	2 years
Rate of circumferential resection margin (CRM) clearance	2 years
Rate of tumour downstaging	2 years
Number of Participants with Adverse Events	2 years
disease-free survival, relapse-free survival	5 years
Time to local (and distant) recurrence	5 years
Number of patients with 30-day post-operative mortality	1 month
Compliance to study treatment	2 years
Number of response to neoadjuvant therapy	2 years

Collaborators and Investigators

• Sponsor: Chinese University of Hong Kong
• Investigators: Principal Investigator: Brigette MA, MD, FRCP, Chinese University of Hong Kong

Study record dates

Study Major Dates

• Study Start (Actual): October 9, 2013
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): December 31, 2027

Study Registration Dates

• First Submitted: September 3, 2013
• First Submitted That Met QC Criteria: September 10, 2013
• First Posted (Estimated): September 13, 2013

Study Record Updates

• Last Update Posted (Estimated): November 17, 2025
• Last Update Submitted That Met QC Criteria: November 13, 2025
• Last Verified: November 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms by Site; Neoplasms; Intestinal Diseases; Gastrointestinal Neoplasms; Digestive System Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Colorectal Neoplasms; Intestinal Neoplasms; Rectal Diseases; Rectal Neoplasms; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Nucleic Acids, Nucleotides, and Nucleosides; Deoxycytidine; Cytidine; Pyrimidine Nucleosides; Pyrimidines; Nucleosides; Uracil; Pyrimidinones; Deoxyribonucleosides; Fluorouracil; Capecitabine
• Other Study ID Numbers: COL021