Status:
UNKNOWN
IXO (Irinotecan, Xeloda, Oxaliplatin) in Rectal Cancer
Lead Sponsor:
Ottawa Hospital Research Institute
Collaborating Sponsors:
Ottawa Regional Cancer Foundation
Sanofi
Conditions:
Rectal Cancer
Eligibility:
All Genders
18-80 years
Phase:
PHASE2
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) follow...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
September 1 2010
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2017
Estimated Enrollment :
15 Patients enrolled
Trial Details
Trial ID
NCT01237665
Start Date
September 1 2010
End Date
December 1 2017
Last Update
October 15 2012
Active Locations (1)
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1
The Ottawa Hospital Cancer Centre
Ottawa, Ontario, Canada, K1H 8L6