Overview

This trial is active, not recruiting.

Condition rectal cancer
Treatment ixo regimen
Phase phase 2
Sponsor Ottawa Hospital Research Institute
Collaborator Ottawa Regional Cancer Foundation
Start date September 2010
End date December 2012
Trial size 15 participants
Trial identifier NCT01237665, OTT 09-02

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation non-randomized
Endpoint classification safety/efficacy study
Intervention model single group assignment
Masking open label
Primary purpose treatment
Arm
(Experimental)
single-group
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 Outcomes

Measure
Pathological complete response (pCR)
time frame: 26 weeks

Secondary Outcomes

Measure
Objective Response
time frame: 12 weeks and 18 weeks
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
Recurrence
time frame: q6 months
RFS, PFS, TTR
time frame: q6 months
Quality of life
time frame: enrolment, 12 weeks, 18 weeks, 26 weeks
Surgical morbidity and mortality
time frame: 26 weeks
Rate of post-operative sphincter preservation
time frame: 26 weeks
OS
time frame: q6 months first 2 years and annually thereafter

Eligibility Criteria

Male or female participants from 18 years up to 80 years old.

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

Additional Information

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
Principal investigator Derek Jonker, MD
Trial information was received from ClinicalTrials.gov and was last updated in October 2012.
Information provided to ClinicalTrials.gov by Ottawa Hospital Research Institute.