A Phase 2 interventional study of IXO regimen in Rectal Cancer, sponsored by Ottawa Hospital Research Institute. Status unknown at 1 site in Canada. Open to participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2012-10-15.
Sponsored by Ottawa Hospital Research Institute · Phase 2, Interventional, and Treatment
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.
1,762 studies on the registry are indexed under Rectal Neoplasms; 518 are open to participants now.
This study's planned enrollment of 15 is below the median of 65 across 1,298 interventional studies indexed under Rectal Neoplasms.
Browse Rectal Neoplasms studies →Ottawa Hospital Research Institute is the lead sponsor of 538 studies on the registry; 100 are open to participants now.
Counted across the registry records on this site, refreshed daily.
General
Resectability
Exclusion Criteria:
Resectability
Prior treatment
Other conditions
Pregnancy / Contraception
single-group
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.
Pathological complete response (pCR)
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)
Time frame: 26 weeks
Objective Response
Objective Response by MRI - post IXO and post RCT
Time frame: 12 weeks and 18 weeks
Number of Participants with Adverse Events as a Measure of Safety and Tolerability
Toxicity according to the NCI Common Terminology Criteria for Adverse Events (CTCAE) v.3.0 and drug safety
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
Rates of local and distant disease recurrence
Time frame: q6 months
RFS, PFS, TTR
Recurrence free survival (RFS), progression free survival (PFS), time to recurrence (TTR)
Time frame: q6 months
Quality of life
Quality of life (QoL) as assessed by the EORTC QLQ-C30 scale
Time frame: enrolment, 12 weeks, 18 weeks, 26 weeks
Surgical morbidity and mortality
post-operative
Time frame: 26 weeks
Rate of post-operative sphincter preservation
post-operative
Time frame: 26 weeks
OS
overall survival (OS)
Time frame: q6 months first 2 years and annually thereafter
This study is status unknown, as verified in Oct 2012. You cannot join it, but the record below documents what was studied.
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Ottawa Hospital Research Institute