Rectal NeoplasmsPhase 2NCT00421824
Study of Neoadjuvant Chemotherapeutic Treatment (XELOX) Followed by Chemoradiotherapy (XELOX/RT) and Surgery Versus Chemoradiotherapy Followed by Surgery and Chemotherapy in Patients With High Risk Rectal Cancer
A Phase 2 study testing Oxaliplatin, capecitabine in people with Rectal Neoplasms, run by Sanofi at 1 site in Spain.
Trial summary
Primary: To assess complete pathological response rate of both strategies. Secondary: Safety profile To assess downstaging rate of both strategies. To compare relative dose intensity of oxaliplatin and capecitabine of both strategies To compare time to progression and overall survival of both strategies. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Rectal Neoplasms
- What is being tested?
- Oxaliplatin, capecitabine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 108 participants
- Where
- 1 siteSpain
- Study dates
- May 2006to Nov 2010
- 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 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients with rectal adenocarcinoma.
- Operable tumour, confirmed by magnetic resonance of high resolution and / or endorectal echography, or,
- Rectal tumour at distal third, or
- Tumours spread more than 5 mm in perirectal fat
- Functional state ECOG ≤ 2.
- Good hematological, hepatic and renal function
Who cannot join
- Previous pelvis radiotherapy.
- Previous antitumoural chemotherapy
- Pregnant or breastfeeding women.
- Childbearing women with a positive pregnancy test result at baseline. Menopausal women should not have the period for the last 12 months.
- History of any other neoplastic illness within the last 5 years, except for already resolved small cell skin cancer or cervix cancer.
- Clinically significant cardiovascular disease
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- Confirmed peripheral neuropathy.
- Gastrointestinal disorders or bad absorption syndrome or non-capable to take oral medication.
- Blood disorders.
- Intercurrent non-controlled or severe infections.
- Patients who have undergone major surgery, open biopsies or with significant trauma lesions within the previous 28 days.
- 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
1 site in 1 country.
About this study
Official title: Phase II Randomized Trial of Neoadjuvant Chemotherapeutic Treatment (XELOX) Followed by Chemoradiotherapy (XELOX/RT) and Surgery Versus Chemoradiotherapy Followed by Surgery and Chemotherapy in Patients With High Risk Rectal Cancer
Primary:
- To assess complete pathological response rate of both strategies.
Secondary:
- Safety profile
- To assess downstaging rate of both strategies.
- To compare relative dose intensity of oxaliplatin and capecitabine of both strategies
- To compare time to progression and overall survival of both strategies.
- Conditions
- Rectal Neoplasms
- Being tested
- Oxaliplatin, capecitabine
- 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, capecitabineDrug
Also called Radiotherapy
OXA 130 D1 + Capecitabine 2000 / day D1-D14 for 4 cycles. After 10 weeks of rest, XELOX-RT regimen x 5 weeks followed by surgery
Oxaliplatin, capecitabineDrug
Also called Radiotherapy
XELOX-RT x 5 weeks followed by surgery and 4 cycles of adjuvant XELOX with the same scheme as arm A.
| Study group | Role | What they receive |
|---|---|---|
| A | Experimental | Not described Receives: Drug: Oxaliplatin, capecitabine |
| B | Experimental | Not described Receives: Drug: Oxaliplatin, capecitabine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Response rate
Measured: from the signature of Informed Consent up to the end of the study
Secondary outcomes (3)
Relative dose intensity
Measured: from the signature of Informed Consent up to end of the study
Disease free survival
Measured: from the signature of Informed Consent up to end of the study
Overall survival
Measured: from the signature of Informed Consent up to end of the study
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jan 2007 (estimated)
- Study startMay 2006
- Primary completionNov 2010
- Study completionNov 2010
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
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 108 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sanofi
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- José Mª Taboada, Dr., Study director, Sanofi
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00421824
- Sponsor's protocol ID
- PM_L_0098
- Other IDs
- EudraCT # : 2005-005149-20
- Status last verified
- Jan 2011
- First submitted
- 11 Jan 2007
- Last updated
- 4 Jan 2011
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Jan 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase II Randomized Trial of Neoadjuvant Chemotherapeutic Treatment (XELOX) Followed by Chemoradiotherapy (XELOX/RT) and Surgery Versus Chemoradiotherapy Followed by Surgery and Chemotherapy in Patients With High Risk Rectal Cancer
- ClinicalTrials.gov ID
- NCT00421824
- Acronym / sponsor ID
- PM_L_0098
- Conditions
- Rectal Neoplasms
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 108 participants (actual)
- Lead sponsor
- SanofiIndustry (pharma, biotech, devices)
- Study start
- May 2006
- Primary completion
- Nov 2010 (actual)
- Study completion
- Nov 2010 (actual)
- First posted
- 12 Jan 2007 (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:
- To assess complete pathological response rate of both strategies.
Secondary:
- Safety profile
- To assess downstaging rate of both strategies.
- To compare relative dose intensity of oxaliplatin and capecitabine of both strategies
- To compare time to progression and overall survival of both strategies.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| A | Experimental | Drug: Oxaliplatin, capecitabine |
| B | Experimental | Drug: Oxaliplatin, capecitabine |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Patients with rectal adenocarcinoma.
- Operable tumour, confirmed by magnetic resonance of high resolution and / or endorectal echography, or,
- Rectal tumour at distal third, or
- Tumours spread more than 5 mm in perirectal fat
- Functional state ECOG ≤ 2.
Key exclusion criteria (12 listed)
- Previous pelvis radiotherapy.
- Previous antitumoural chemotherapy
- Pregnant or breastfeeding women.
- Childbearing women with a positive pregnancy test result at baseline. Menopausal women should not have the period for the last 12 months.
- History of any other neoplastic illness within the last 5 years, except for already resolved small cell skin cancer or cervix cancer.
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, capecitabineAlso: RadiotherapyOXA 130 D1 + Capecitabine 2000 / day D1-D14 for 4 cycles. After 10 weeks of rest, XELOX-RT regimen x 5 weeks followed by surgery | Drug | A |
| Oxaliplatin, capecitabineAlso: RadiotherapyXELOX-RT x 5 weeks followed by surgery and 4 cycles of adjuvant XELOX with the same scheme as arm A. | Drug | B |
Primary outcome
Response rate
Time frame: from the signature of Informed Consent up to the end of the study
3 secondary outcomes
Relative dose intensity
Time frame: from the signature of Informed Consent up to end of the study
Disease free survival
Time frame: from the signature of Informed Consent up to end of the study
Overall survival
Time frame: from the signature of Informed Consent up to end of the 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 4 Jan 2011.
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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.
José Mª Taboada, Dr. study director
Sanofi
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 Oxaliplatin, capecitabine in people with Rectal Neoplasms, run by Sanofi at 1 site in Spain.
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 6 inclusion and 12 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: finished, as of the sponsor's last update on 4 Jan 2011. 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 Spain. 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?
Response rate (time frame: from the signature of Informed Consent up to the end of the study). 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 4 Jan 2011.