IXO (Irinotecan, Xeloda, Oxaliplatin) in Rectal Cancer

Rectal Cancer Clinical Trial

— IXOr  

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT01237665
• Other study ID #: OTT 09-02
• Status: Active, not recruiting
• Phase: Phase 2
• First received: August 25, 2010
• Last updated: October 12, 2012
• Start date: September 2010
• Est. completion date: December 2017

Study information

• Verified date: October 2012
• Source: Ottawa Hospital Research Institute
• Contact: n/a
• Is FDA regulated: No
• Health authority: Canada: Health CanadaCanada: Ethics Review Committee
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 15
• Est. completion date: December 2017
• Est. primary completion date: December 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 80 Years

Eligibility

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

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Rectal Cancer
• Rectal Neoplasms

Intervention

Drug:
• IXO regimen
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.

Locations

Country	Name	City	State
Canada	The Ottawa Hospital Cancer Centre	Ottawa	Ontario

Sponsors (4)

Lead Sponsor	Collaborator
Ottawa Hospital Research Institute	Hoffmann-La Roche, Ottawa Regional Cancer Foundation, Sanofi

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	Objective Response	Objective Response by MRI - post IXO and post RCT	12 weeks and 18 weeks	No
Secondary	Number of Participants with Adverse Events as a Measure of Safety and Tolerability	Toxicity according to the NCI Common Terminology Criteria for Adverse Events (CTCAE) v.3.0 and drug safety	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	Yes
Secondary	Recurrence	Rates of local and distant disease recurrence	q6 months	No
Secondary	RFS, PFS, TTR	Recurrence free survival (RFS), progression free survival (PFS), time to recurrence (TTR)	q6 months	No
Secondary	Quality of life	Quality of life (QoL) as assessed by the EORTC QLQ-C30 scale	enrolment, 12 weeks, 18 weeks, 26 weeks	No
Secondary	Surgical morbidity and mortality	post-operative	26 weeks	Yes
Secondary	Rate of post-operative sphincter preservation	post-operative	26 weeks	No
Secondary	OS	overall survival (OS)	q6 months first 2 years and annually thereafter	No