Colon Neoadjuvant FOLFOXIRI Study

NCT ID: NCT01941641

Last Updated: 2025-11-17

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Clinical Phase: PHASE2
• Total Enrollment: 40 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-10-09
• Study Completion Date: 2027-12-31

Brief Summary

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

Conditions

Rectal Cancer

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

neoadjuvant FOLFOXIRI

Group Type: EXPERIMENTAL

neoadjuvant FOLFOXIRI

Intervention Type: DRUG

Capecitabine

Intervention Type: DRUG

Interventions

neoadjuvant FOLFOXIRI

Intervention Type: DRUG

Capecitabine

Intervention Type: DRUG

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Chinese University of Hong Kong

OTHER

Sponsor Role: lead

Responsible Party

CCTU

Comprehensive Cancer Trials Unit

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Brigette MA, MD, FRCP

Role: PRINCIPAL_INVESTIGATOR

Chinese University of Hong Kong

Locations

Department of Clinical Oncology

Hong Kong, , Hong Kong

Countries

Hong Kong

Other Identifiers

COL021

Identifier Type: -

Identifier Source: org_study_id