Clinical trial NCT01237665: IXO (Irinotecan, Xeloda, Oxaliplatin) in Rectal Cancer
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 type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
Conditions: Rectal Cancer
Keywords: locally resectable advanced adenocarcinoma of the rectum
Lead sponsor: Ottawa Hospital Research Institute
Sponsor class: OTHER
Collaborators: name: Ottawa Regional Cancer Foundation
name: Sanofi
name: Hoffmann-La Roche
First posted: 2010-11-09
Enrollment: 15
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


Eligibility criteria: 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

Primary outcomes:
measure: Pathological complete response (pCR)
timeFrame: 26 weeks
Secondary outcomes:
measure: Objective Response
timeFrame: 12 weeks and 18 weeks
measure: Number of Participants with Adverse Events as a Measure of Safety and Tolerability
timeFrame: 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
measure: Recurrence
timeFrame: q6 months
measure: RFS, PFS, TTR
timeFrame: q6 months
measure: Quality of life
timeFrame: enrolment, 12 weeks, 18 weeks, 26 weeks
measure: Surgical morbidity and mortality
timeFrame: 26 weeks
measure: Rate of post-operative sphincter preservation
timeFrame: 26 weeks
measure: OS
timeFrame: q6 months first 2 years and annually thereafter
Other outcomes:
Locations:
city: Ottawa
country: Canada
facility: The Ottawa Hospital Cancer Centre
state: Ontario
Study officials:
affiliation: The Ottawa Hospital Cancer Centre
name: Derek Jonker, MD
role: PRINCIPAL_INVESTIGATOR
References: