IXO (Irinotecan, Xeloda, Oxaliplatin) in Rectal Cancer (IXOr)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01237665
Recruitment Status : Unknown
Verified October 2012 by Ottawa Hospital Research Institute.
Recruitment status was:  Active, not recruiting
First Posted : November 9, 2010
Last Update Posted : October 15, 2012
Ottawa Regional Cancer Foundation
Hoffmann-La Roche
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment Phase
Rectal Cancer Drug: IXO regimen Phase 2

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 15 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase II Trial of Neoadjuvant IXO Regimen (Irinotecan, Capecitabine [Xeloda], Oxaliplatin) Followed by Combined Modality Capecitabine and Radiation for Locally Resectable Advanced Rectal Cancer
Study Start Date : September 2010
Estimated Primary Completion Date : December 2012
Estimated Study Completion Date : December 2017

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
Experimental: IXO regimen
Drug: IXO regimen

IXO regimen is administered as following: irinotecan 160 mg/m2 i.v. (over 60-90 minutes) with oxaliplatin 100 mg/m2 i.v. (over 120 minutes) on day 1, followed by capecitabine 950 mg/m2 PO, b.i.d. on days 2-15, every 3 weeks.

Each cycle of IXO lasts 21 days, with the subsequent cycle to start on day 22.

Primary Outcome Measures :
  1. Pathological complete response (pCR) [ Time Frame: 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 :
  1. Objective Response [ Time Frame: 12 weeks and 18 weeks ]
    Objective Response by MRI - post IXO and post RCT

  2. Number of Participants with Adverse Events as a Measure of Safety and Tolerability [ Time Frame: 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

  3. Recurrence [ Time Frame: q6 months ]
    Rates of local and distant disease recurrence

  4. RFS, PFS, TTR [ Time Frame: q6 months ]
    Recurrence free survival (RFS), progression free survival (PFS), time to recurrence (TTR)

  5. Quality of life [ Time Frame: enrolment, 12 weeks, 18 weeks, 26 weeks ]
    Quality of life (QoL) as assessed by the EORTC QLQ-C30 scale

  6. Surgical morbidity and mortality [ Time Frame: 26 weeks ]

  7. Rate of post-operative sphincter preservation [ Time Frame: 26 weeks ]

  8. OS [ Time Frame: q6 months first 2 years and annually thereafter ]
    overall survival (OS)

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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:


  • 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


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

Exclusion Criteria:


  • 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01237665

Canada, Ontario
The Ottawa Hospital Cancer Centre
Ottawa, Ontario, Canada, K1H 8L6
Sponsors and Collaborators
Ottawa Hospital Research Institute
Ottawa Regional Cancer Foundation
Hoffmann-La Roche
Principal Investigator: Derek Jonker, MD The Ottawa Hospital Cancer Centre

Responsible Party: Ottawa Hospital Research Institute Identifier: NCT01237665     History of Changes
Other Study ID Numbers: OTT 09-02
First Posted: November 9, 2010    Key Record Dates
Last Update Posted: October 15, 2012
Last Verified: October 2012

Keywords provided by Ottawa Hospital Research Institute:
locally resectable advanced adenocarcinoma of the rectum

Additional relevant MeSH terms:
Rectal Neoplasms
Colorectal Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Digestive System Diseases
Gastrointestinal Diseases
Intestinal Diseases
Rectal Diseases
Antimetabolites, Antineoplastic
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Antineoplastic Agents, Phytogenic
Topoisomerase I Inhibitors
Topoisomerase Inhibitors
Enzyme Inhibitors