IXO (Irinotecan, Xeloda, Oxaliplatin) in Rectal Cancer (NCT01237665) | Clinical Trial Compass
UnknownPhase 2
IXO (Irinotecan, Xeloda, Oxaliplatin) in Rectal Cancer
Canada15 participantsStarted 2010-09
Plain-language 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.
Who can participate
Age range18 Years – 80 Years
SexALL
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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 proc…