IXO (Irinotecan, Xeloda, Oxaliplatin) in Rectal Cancer

Phase 2

• Conditions: Rectal Cancer
• Interventions: Drug: IXO regimen

• Registration Number: NCT01237665
• Lead Sponsor: Ottawa Hospital Research Institute

Brief Summary

This is a prospective open label single-arm, single-institution phase II clinical trial to test the efficacy of neoadjuvant treatment with IXO (Irinotecan, Capecitabine \[Xeloda\], Oxaliplatin) followed by chemoradiotherapy and resection in patients with resectable non-metastatic primary rectal cancer of stage cT3-T4 N0-N2.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2010-08-25
• Study Start: 2010-09
• Study First Submitted QC: 2010-11-08
• Study First Posted: 2010-11-09
• Status Verified: 2012-10
• Last Update Submitted: 2012-10-12
• Last Update Posted: 2012-10-15
• Primary Completion: 2012-12
• Study Completion: 2017-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 15

Inclusion Criteria

General

• Pathologically confirmed rectal adenocarcinoma
• T3 or T4 or N1 (node ≥1 cm on short axis) adenocarcinoma of the rectum.
• ECOG performance status equal or less than 1
• Male and female patients, aged ≥ 18 years and ≤ 80 years
• Written informed consent
• Adequate haematological, liver, renal function

Resectability

• Patients categorized as having resectable locally advanced cancer
• Favorable general condition

Exclusion Criteria

Resectability

• Diagnosis of metastatic disease
• Clear indication of involvement of pelvic wall(s), on imaging.
• Peritoneal carcinomatosis, portal vein occlusion, ascites, non-regional lymph nodes
• Histology other than adenocarcinoma
• Obstructed rectal carcinoma without defunctionalizing colostomy

Prior treatment

• Previously undergone treatment for this disease
• Prior chemotherapy for colorectal cancer
• Prior chemotherapy for other malignancies in past 12 months
• Prior radiotherapy other than skin cancer
• Concomitant use of St John's Wort
• Treatment with any other investigational agent
• Current use of full-dose of warfarin for therapeutic

Other conditions

• Confirmed or suspected brain metastases
• History or evidence of CNS disease
• Past or current history of other malignancies
• Clinically significant cardiovascular disease
• Evidence of bleeding diathesis or coagulopathy
• Known hypersensitivity to any of the study drugs
• Serious, non-healing wound, ulcer or bone fracture
• Major surgical procedure or significant traumatic injury within 28 days prior to treatment
• Disease or condition that contraindicates the use of an investigational drug
• Life expectancy less than 5 years
• Inability or unwillingness to comply with the protocol
• Neuropathy ≥ Gr.2
• History of ulcerative colitis or Crohn's disease
• Pelvic abscess or perforated pelvic carcinoma

Pregnancy / Contraception

• Pregnancy or lactation
• Positive serum pregnancy test within 7 days of starting study treatment

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
IXO regimen	IXO regimen	single-group

Primary Outcome Measures

Name	Time	Method
Pathological complete response (pCR)	26 weeks	To test the efficacy of neoadjuvant treatment with IXO followed by chemoradiotherapy and surgical resection, evaluated as histological therapy-induced tumour regression, assessed by the rate of pathological complete response (pCR) at the primary tumor site (pT0)

Secondary Outcome Measures

Name	Time	Method
Objective Response	12 weeks and 18 weeks	Objective Response by MRI - post IXO and post RCT
Number of Participants with Adverse Events as a Measure of Safety and Tolerability	every 3 weeks during neoadjuvant chemotherapy; before CRT; 3rd week of CRT; 2 days, 3 weeks and 6 weeks post CRT; pre-op; 2 days and 4 weeks post-op	Toxicity according to the NCI Common Terminology Criteria for Adverse Events (CTCAE) v.3.0 and drug safety
Recurrence	q6 months	Rates of local and distant disease recurrence
RFS, PFS, TTR	q6 months	Recurrence free survival (RFS), progression free survival (PFS), time to recurrence (TTR)
Quality of life	enrolment, 12 weeks, 18 weeks, 26 weeks	Quality of life (QoL) as assessed by the EORTC QLQ-C30 scale
Surgical morbidity and mortality	26 weeks	post-operative
Rate of post-operative sphincter preservation	26 weeks	post-operative
OS	q6 months first 2 years and annually thereafter	overall survival (OS)

Trial Locations

Locations (1)

The Ottawa Hospital Cancer Centre; 🇨🇦 Ottawa, Ontario, Canada