Rectal NeoplasmsPhase 2NCT00174616
CORE: Capecitabine, Oxaliplatin, Radiotherapy and Excision
A Phase 2 study testing Oxaliplatin, capecitabine, radiotherapy in people with Rectal Neoplasms, run by Sanofi at 7 sites in 7 countries.
Trial summary
Primary objective: Pathological complete response (ypT0N0) rate Secondary objectives: Histopathological R0 resection rate Pathological downstaging (ypT0-T2N0) rate One month surgical complication rate Predictive value of pre-operative MRI for surgical, pathological and clinical outcomes Safety Local and distant… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Rectal Neoplasms
- What is being tested?
- Oxaliplatin, capecitabine, radiotherapy
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 87 participants
- Where
- 7 sitesin 7 countries
- Study dates
- Jul 2003to Nov 2007
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
- Histologically proven adenocarcinoma of the rectum (Tumour ≤ 12 cm from the anal verge)
- No evidence of distant spread
- No prior therapy for chemotherapy or radiation therapy for rectal cancer
- Patient considered locally advanced by MRI:
- Tumour beyond mesorectal fascia, or
- Tumour ≤ 2mm from mesorectal fascia, or
- T3 tumour < 5cm from anal verge
- For female patient of childbearing potential, neither pregnant nor breastfeeding, and under active contraception
- No peripheral neuropathy > grade1
- ECOG PS ≤ 2
- ANC > 1,500 x 10^9/L
- Platelets > 100,000 x 10^9/L
- Creatinine < 1.5 x IULN
- Bilirubin < 1.5 IULN
- SGPT (ALT) < 2.5 IULN
- No pre-existing condition which would deter chemoradiotherapy
- No uncontrolled diarrhoea or fecal incontinence
- No significant small bowel (> 200cc or 6X6X6cm) delineated within the radiation fields
- No other serious uncontrolled concomitant illness
- Informed consent signed
The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.
Trial locations and contacts
7 sites in 7 countries.
7 sites in 7 countries
United Kingdom1 site
Sanofi-Aventis Administrative Office
Guildford Surrey
About this study
Official title: Phase 2 Study of Weekly Oxaliplatin and Capecitabine (XELOX) in Combination With Preoperative Radiotherapy in Patients With MRI Defined Locally Advanced Rectal Cancer
Primary objective:
- Pathological complete response (ypT0N0) rate
Secondary objectives:
- Histopathological R0 resection rate
- Pathological downstaging (ypT0-T2N0) rate
- One month surgical complication rate
- Predictive value of pre-operative MRI for surgical, pathological and clinical outcomes
- Safety
- Local and distant recurrence rates
- Progression-free survival
- Overall survival
- Conditions
- Rectal Neoplasms
- Being tested
- Oxaliplatin, capecitabine, radiotherapy
- Medical subject headings
- Rectal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Oxaliplatin, capecitabine, radiotherapyDrug
- Oxaliplatin 50mg/m² I.V. 2 hours weekly x 5 doses
- Capecitabine 825mg/m² P.O. B.I.D. daily x 5 days x 5 weeks
- Radiotherapy 45 Gy total (1.8Gy/dose) 25 fractions daily x 5 days x 5 weeks
| Study group | Role | What they receive |
|---|---|---|
| Single arm | Experimental | Not described Receives: Drug: Oxaliplatin, capecitabine, radiotherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
MRI staging and TME surgery
Measured: within 4 - 6 weeks after completion XELOX-RT
Secondary outcomes (1)
Measure safety - NCI-CTC version 2
Measured: from baseline to end of study
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Sep 2005 (estimated)
- Study startJul 2003
- Primary completionNov 2007
- Study completionNov 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Rectal NeoplasmsStudies of the same condition, open and under way.
- More trials run by SanofiThe 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
- 87 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sanofi
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Jean-Philippe Aussel, Study director, Sanofi
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00174616
- Sponsor's protocol ID
- C_8601
- Status last verified
- Dec 2009
- First submitted
- 9 Sep 2005
- Last updated
- 7 Dec 2009
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Dec 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase 2 Study of Weekly Oxaliplatin and Capecitabine (XELOX) in Combination With Preoperative Radiotherapy in Patients With MRI Defined Locally Advanced Rectal Cancer
- ClinicalTrials.gov ID
- NCT00174616
- Acronym / sponsor ID
- C_8601
- Conditions
- Rectal Neoplasms
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 87 participants (actual)
- Lead sponsor
- SanofiIndustry (pharma, biotech, devices)
- Study start
- Jul 2003
- Primary completion
- Nov 2007 (actual)
- Study completion
- Nov 2007 (actual)
- First posted
- 15 Sep 2005 (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.
Primary objective:
- Pathological complete response (ypT0N0) rate
Secondary objectives:
- Histopathological R0 resection rate
- Pathological downstaging (ypT0-T2N0) rate
- One month surgical complication rate
- Predictive value of pre-operative MRI for surgical, pathological and clinical outcomes
- Safety
- Local and distant recurrence rates
- Progression-free survival
- Overall survival
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Single arm | Experimental | Drug: Oxaliplatin, capecitabine, radiotherapy |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
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 |
|---|---|---|
| Oxaliplatin, capecitabine, radiotherapy* Oxaliplatin 50mg/m² I.V. 2 hours weekly x 5 doses * Capecitabine 825mg/m² P.O. B.I.D. daily x 5 days x 5 weeks * Radiotherapy 45 Gy total (1.8Gy/dose) 25 fractions daily x 5 days x 5 weeks | Drug | Single arm |
Primary outcome
MRI staging and TME surgery
Time frame: within 4 - 6 weeks after completion XELOX-RT
1 secondary outcome
Measure safety - NCI-CTC version 2
Time frame: from baseline to end of study
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Dec 2009.
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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.
Jean-Philippe Aussel study director
Sanofi
7 sites in 7 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Oxaliplatin, capecitabine, radiotherapy in people with Rectal Neoplasms, run by Sanofi at 7 sites in 7 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
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: finished, as of the sponsor's last update on 7 Dec 2009. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 7 sites in Belgium, France, Germany, Italy, Netherlands and 2 more countries. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
MRI staging and TME surgery (time frame: within 4 - 6 weeks after completion XELOX-RT). 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 7 Dec 2009.