IXO (Irinotecan, Xeloda, Oxaliplatin) in Rectal Cancer

• Status: Unknown status
• Trial end date: 2017-12-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Ottawa Hospital Research Institute
• Collaborators: Hoffmann-La Roche; Ottawa Regional Cancer Foundation; Sanofi
• Treatments: Capecitabine; Irinotecan; Oxaliplatin

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