Colon Neoadjuvant FOLFOXIRI Study

Rectal Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT01941641
• Other study ID #: COL021
• Status: Active, not recruiting
• Phase: Phase 2
• Start date: October 9, 2013
• Est. completion date: December 31, 2025

Study information

• Verified date: April 2023
• Source: Chinese University of Hong Kong
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 40
• Est. completion date: December 31, 2025
• Est. primary completion date: December 31, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Rectal Cancer
• Rectal Neoplasms

Intervention

Drug:
• neoadjuvant FOLFOXIRI

• Capecitabine

Locations

Country	Name	City	State
Hong Kong	Department of Clinical Oncology	Hong Kong

Sponsors (1)

Lead Sponsor	Collaborator
Chinese University of Hong Kong

Country where clinical trial is conducted

Hong Kong, 

Outcome

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