FOLFOXIRI With or Without Intensification for Rectal Cancer

NCT03997435 | Active Not Recruiting Phase 2

• 1 other identifier: COL026
• Study Type: interventional
• Target: 72
• Locations: 1 country
• Sites: 3

Brief Summary

Pathologic complete response rate

Conditions

Rectal Cancer

Outcome Measures

Primary Outcomes (1)

• Rate of pathologic complete response

  2 years

Secondary Outcomes (11)

• Rate of tumour regression grade

  2 years

• Number of objective tumour 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

Study Arms (2)

Control arm

EXPERIMENTAL

neoadjuvant concurrent capecitabine-radiotherapy followed by surgery and postoperative chemotherapy

Drug: Control arm

Experimental arm

EXPERIMENTAL

Neoadjuvant FOLFOXIRI x4 cycles, then capecitabine-radiotherapy and postoperative chemotherapy

Drug: Experimental arm

Interventions

Control arm DRUG

neoadjuvant concurrent capecitabine-radiotherapy followed by surgery and postoperative chemotherapy.

Control arm

Experimental arm DRUG

Neoadjuvant FOLFOXIRI x4 cycles, then capecitabine-radiotherapy and postoperative chemotherapy.

Experimental arm

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.
• Patient with hip prosthesis
• Major surgery (i.e. requiring general anaesthetics) 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.
• Known cardiac disease that is symptomatic or poorly controlled, including cardiac failure, arrhythmia or ischemic heart disease.
• Myocardial infarction or cerebrovascular accident within the last 12 months.
• Intercurrent infections or medical illnesses that are serious/ potentially life-threatening and require ongoing treatment.

Sponsors & Collaborators

• CCTU: lead

Study Sites (3)

Department of Clinical Oncology, Queen Mary Hospital

Hong Kong, Hong Kong

Location

Department of Oncology, Princess Margaret Hospital

Hong Kong, Hong Kong

Location

The Chinese University of Hong Kong

Hong Kong, Hong Kong

Location

MeSH Terms

Conditions

Rectal Neoplasms

Condition Hierarchy (Ancestors)

Colorectal Neoplasms; Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Intestinal Diseases; Rectal Diseases

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Comprehensive Cancer Trials Unit, Department of Clinical Oncology, The Chinese University of Hong Kong

Study Record Dates

• First Submitted: June 19, 2019
• First Posted: June 25, 2019
• Study Start: September 10, 2019
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): December 31, 2027
• Last Updated: November 17, 2025

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will not share

Locations

HK (3)