NCT01237665

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
15

participants targeted

Target at below P25 for phase_2

Timeline
Completed

Started Sep 2010

Longer than P75 for phase_2

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 25, 2010

Completed
7 days until next milestone

Study Start

First participant enrolled

September 1, 2010

Completed
2 months until next milestone

First Posted

Study publicly available on registry

November 9, 2010

Completed
2.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2012

Completed
5 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2017

Completed
Last Updated

October 15, 2012

Status Verified

October 1, 2012

Enrollment Period

2.3 years

First QC Date

August 25, 2010

Last Update Submit

October 12, 2012

Conditions

Rectal Cancer

Keywords

locally resectable advanced adenocarcinoma of the rectum

Outcome Measures

Primary Outcomes (1)

  • 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)

    26 weeks

Secondary Outcomes (8)

  • Objective Response

    12 weeks and 18 weeks

  • 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

  • Recurrence

    q6 months

  • RFS, PFS, TTR

    q6 months

  • Quality of life

    enrolment, 12 weeks, 18 weeks, 26 weeks

  • +3 more secondary outcomes

Study Arms (1)

IXO regimen

EXPERIMENTAL

single-group

Drug: IXO regimen

Interventions

IXO regimenDRUG

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.

IXO regimen

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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
  • +17 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

The Ottawa Hospital Cancer Centre

Ottawa, Ontario, K1H 8L6, Canada

Location

MeSH Terms

Conditions

Rectal Neoplasms

Condition Hierarchy (Ancestors)

Colorectal NeoplasmsIntestinal NeoplasmsGastrointestinal NeoplasmsDigestive System NeoplasmsNeoplasms by SiteNeoplasmsDigestive System DiseasesGastrointestinal DiseasesIntestinal DiseasesRectal Diseases

Study Officials

  • Derek Jonker, MD

    The Ottawa Hospital Cancer Centre

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 25, 2010

First Posted

November 9, 2010

Study Start

September 1, 2010

Primary Completion

December 1, 2012

Study Completion

December 1, 2017

Last Updated

October 15, 2012

Record last verified: 2012-10

Locations

CA(1)