Rectal CancerPhase 2IXOrNCT01237665
IXO (Irinotecan, Xeloda, Oxaliplatin) in Rectal Cancer
A Phase 2 study testing IXO regimen in people with Rectal Cancer, run by Ottawa Hospital Research Institute at 1 site in Canada.
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… Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Rectal Cancer
- What is being tested?
- IXO regimen
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 15 participants
- Where
- 1 siteCanada
- Study dates
- Sep 2010to Dec 2017
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
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- Adequate haematological, liver, renal function
- Resectability
- Patients categorized as having resectable locally advanced cancer
- Favorable general condition
Who cannot join
- 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
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- 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
Trial locations and contacts
1 site in 1 country.
About this study
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
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.
- Conditions
- Rectal Cancer
- Being tested
- IXO regimen
- Keywords
- locally resectable advanced adenocarcinoma of the rectum
- Medical subject headings
- Rectal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
IXO regimenDrug
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.
| Study group | Role | What they receive |
|---|---|---|
| IXO regimen | Experimental | single-group Receives: Drug: IXO regimen |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: 26 weeks
Secondary outcomes (8)
Objective Response
Objective Response by MRI - post IXO and post RCT
Measured: 12 weeks and 18 weeks
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
Measured: 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
Recurrence
Rates of local and distant disease recurrence
Measured: q6 months
RFS, PFS, TTR
Recurrence free survival (RFS), progression free survival (PFS), time to recurrence (TTR)
Measured: q6 months
Quality of life
Quality of life (QoL) as assessed by the EORTC QLQ-C30 scale
Measured: enrolment, 12 weeks, 18 weeks, 26 weeks
Surgical morbidity and mortality
post-operative
Measured: 26 weeks
Rate of post-operative sphincter preservation
post-operative
Measured: 26 weeks
OS
overall survival (OS)
Measured: q6 months first 2 years and annually thereafter
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Nov 2010 (estimated)
- Study startSep 2010
- Primary completionDec 2012 (estimated)
- Study completionDec 2017 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Rectal CancerStudies of the same condition, open and under way.
- More trials run by Ottawa Hospital Research InstituteThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 15 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ottawa Hospital Research Institute
- Sponsor type
- University, hospital or other
- Collaborators
- Ottawa Regional Cancer Foundation, Sanofi, Hoffmann-La Roche
- Responsible party
- Sponsor
- Investigators
- Derek Jonker, MD, Principal investigator, The Ottawa Hospital Cancer Centre
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01237665
- Sponsor's protocol ID
- OTT 09-02
- Acronym
- IXOr
- Status last verified
- Oct 2012
- First submitted
- 25 Aug 2010
- Last updated
- 15 Oct 2012
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 15 Oct 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT01237665
- Acronym / sponsor ID
- IXOr / OTT 09-02
- Conditions
- Rectal Cancer
- Keywords
- locally resectable advanced adenocarcinoma of the rectum
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 15 participants (estimated)
- Lead sponsor
- Ottawa Hospital Research InstituteUniversity, hospital or other
- Collaborators
- Ottawa Regional Cancer Foundation, Sanofi, Hoffmann-La Roche
- Study start
- Sep 2010
- Primary completion
- Dec 2012 (estimated)
- Study completion
- Dec 2017 (estimated)
- First posted
- 9 Nov 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| IXO regimen | Experimental | Drug: IXO regimensingle-group |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- 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
Key exclusion criteria (32 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| IXO regimenIXO 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. | Drug | IXO regimen |
Primary outcome
Pathological complete response (pCR)
Time frame: 26 weeks
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)
8 secondary outcomes
Objective Response
Time frame: 12 weeks and 18 weeks
Number of Participants with Adverse Events as a Measure of Safety and Tolerability
Time frame: 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
Recurrence
Time frame: q6 months
RFS, PFS, TTR
Time frame: q6 months
Quality of life
Time frame: enrolment, 12 weeks, 18 weeks, 26 weeks
Surgical morbidity and mortality
Time frame: 26 weeks
Rate of post-operative sphincter preservation
Time frame: 26 weeks
OS
Time frame: q6 months first 2 years and annually thereafter
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Oct 2012.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Derek Jonker, MD principal investigator
The Ottawa Hospital Cancer Centre
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing IXO regimen in people with Rectal Cancer, run by Ottawa Hospital Research Institute at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 32 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 15 Oct 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pathological complete response (pCR) (time frame: 26 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Oct 2012.