Colorectal CancerPhase 2SoMoreNCT01290926
Sorafenib Plus Capecitabine Efficacy Assessment in Patients With Advanced Pre-treated Colorectal Cancer
A Phase 2 study testing chemotherapy in people with Colorectal Cancer, run by Jules Bordet Institute at 7 sites in Belgium.
Trial summary
Prospective non-randomized phase II study assessing the activity of the Capecitabine-Sorafenib combination by estimating overall survival of the study population at a fixed time point (6 months) and, as an exploratory analysis the overall survival of metabolic responders versus non-responders. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Colorectal Cancer
- What is being tested?
- chemotherapy
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 97 participants
- Where
- 7 sitesBelgium
- Study dates
- Feb 2011to Jan 2016
- 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
Who may be able to join
- Participants must have histologically confirmed colorectal cancer that is metastatic or unresectable and for which standard curative or palliative measures do not exist or are no longer effective.
- All standard chemotherapy agents (fluoropyrimidines, irinotecan, and oxaliplatin) and monoclonal antibodies (bevacizumab, cetuximab, and panitumumab) are allowed as administered therapy before study entry. No more than two lines of treatment for metastatic or recurrent disease are allowed, except for patients with KRAS-wt tumors, for which third line with anti-EGFR agents is allowed.
- Age over 18 years.
- Life expectancy of greater than 12 weeks.
- ECOG performance status ≤ 1.
- Participants must have normal organ and marrow function as defined below:
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- Leukocytes > 3,000/mcL
- Absolute neutrophil count > 1,500/mcL
- Platelets > 100,000/mcL
- total bilirubin within 2 × normal institutional limits
- AST/ALT/PAKL levels < 5 × institutional upper limit of normal
- creatinine within 2 × normal institutional limits or creatinine clearance > 35mL/min
- Women of child-bearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control, abstinence) prior to study entry and for the duration of study participation. Should a woman become pregnant or suspect she is pregnant while participating in this study, she should inform her treating physician immediately.
- Ability to understand and the willingness to sign a written informed consent document.
Who cannot join
- Participants who exhibit any of the following conditions at screening will not be eligible for admission into the study.
- Participants who have had chemotherapy or radiotherapy within 4 weeks prior to entering the study or those who have not recovered from adverse events due to agents administered more than 4 weeks earlier.
- Participants may not be receiving any other experimental agents.
- Participants with known brain metastases should be excluded from this clinical trial because of their poor prognosis and because they often develop progressive neurologic dysfunction that would confound the evaluation of neurologic and other adverse events.
- History of allergic reactions attributed to compounds of similar chemical or biologic composition to sorafenib or capecitabine.
- Bleeding diathesis, history of cardiovascular ischemic disease or cerebrovascular incident within the last six months, or major surgery within four weeks.
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- Uncontrolled concurrent illness including, but not limited to ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements.
- Pregnant women are excluded from this study because sorafenib and capecitabine are antitumor agents with the potential for teratogenic or abortifacient effects. Because there is an unknown but potential risk of adverse events in nursing infants secondary to treatment of the mother with sorafenib or capecitabine, breastfeeding should be discontinued if the mother is treated with sorafenib or capecitabine. These potential risks may also apply to other agents used in this study.
- Uncontrolled Diabetes
- FDG PET/CT negative lesions or non metabolically assessable lesions (to small <2cm) at the base line FDG PET/CT
- Individuals with a history of a different malignancy are ineligible except for the following circumstances. Individuals with a history of other malignancies are eligible if they have been disease-free for at least 5 years and are deemed by the investigator to be at low risk for recurrence of that malignancy. Individuals with the following cancers are eligible if diagnosed and treated within the past 5 years: cervical cancer in situ, and basal cell or squamous cell carcinoma of the skin.
Trial locations and contacts
7 sites in 1 country.
7 sites in 1 country
Belgium7 sites
Universiteit Ziekenhuis Antwerpen
Antwerp, Antwerpen
Institut Jules Bordet
Brussels, 1000
Hopital Erasme
Brussels, 1070
Entité Jolimontoise
La Louvière
Hopitaux St Joseph
Liège, 4000
CHU Ambroise Paré
Mons, 7000
Cliniques Universitaires Saint Luc
Woluwe-Saint-Lambert, Brussels Capital, 1200
About this study
Prospective non-randomized phase II study assessing the activity of the Capecitabine-Sorafenib combination by estimating overall survival of the study population at a fixed time point (6 months) and, as an exploratory analysis the overall survival of metabolic responders versus non-responders.
Read the detailed description
Treatment doses :
Sorafenib 200mg in the morning,400mg in the evening; escalation to 400mg twice daily after 1 cycle Capecitabine 850mg/m2 twice daily Oral Days 1-14, weeks 1-2
Fluoro-Deoxy Glucose Positron Emitting Tomography (FDG-PET)imaging at baseline and after 17-21 days while on therapy.
Sample size justification/statistical analysis
Sample size has been estimated in order to be able to test the null hypothesis that the overall survival rate at 6 months is less than 30%. This hypothesis will be tested using a binomial distribution. The study should be able to reject the null hypothesis, using a 1-sided test with α = 0.025, with a power of 90% in case of a true overall survival ≥ 50% (rate at 6 months). The sample size required is 66 eligible patients (to be followed for 6 months minimum). Analysis will be done on all registered patients using an ITT approach on all eligible patients.
A co-primary endpoint is to compare the overall survival of patients assessed as early PET responders and of patients assessed as early PET non responders (the clinicians will remain blinded for PET response assessment). For this primary analysis, patients who will undergo the second PET assessment will be eligible and time zero for measuring survival will be the date of this second PET examination. It is anticipated that 95% of the patients will be eligible for the analysis with a 50% expected rate of early PET non-responders (result obtained from an unpublished study conducted at Jules-Bordet Institute). With 66 patients registered, we anticipate then that 63 patients will be available for the co-primary endpoint. With 63 patients and our assumption that the HR for the comparison between the survival distributions will be around 0.385 (based on the previously mentioned unpublished study), we will need using a two-sided logrank test at the 2.5% level (2.5% chosen because of the existence of 2 co-primary endpoints), 54 events (power of 90%). With 63 patients and a follow-up after accrual of 1 year, we should reach this number of 54 events. However, to account for another possible 5% drop-out (patient's refusal for undergoing the second PET examination for instance), sample size should be increased to 70 eligible patients.
However, our estimation of 50% expected rate of early PET responders is coming from a prospective unicentric cohort of 38 patients undergoing chemotherapy for 1st line or 2nd line treatment of advanced colorectal cancer with a few of them having received biological agents together with chemotherapy. Our estimation may then not be reliable due to small sample size and different patients population. If this rate of early PET responders proves to be higher, we should be prepared to increase our sample size for targeting the same power of 90%. For instance, if the rate is 67% instead of 50%, the required number of events would be 62 in-stead of 54. If the rate is 75%, the number of events should be increased to 73. The number of patients would have then to be adapted according to the rate of evaluable patients for this PET objective and the rate of patients lost to follow-up. For reassessing the required numbers of events, we did not change our hypothesis of detecting, if true, a hazard ratio of 0.385 in favor of early PET responders.
We plan, during the course of accrual, to assess the rate of patients evaluable for the PET objective, of early PET responders and, if possible the rate of patients lost to follow-up in order to check whether we need to review our planned sample size. However, no interim analysis will be done on the primary endpoints.
Secondary endpoints are to estimate progression-free survival and objective response rate, and to describe the adverse reactions associated with the study regimen in the study population. Also, to determine the correlation of early metabolic response, as assessed by FDG-PET/CT immediately before the first and the second cycles of treatment with the study regimen, with overall survival, progression-free survival, and response rate, and to determine the correlation of growth modulation index (GMI), defined as the time to progression under the study regimen over the time to progression under the latest regimen administered to the patient, with overall survival and progression-free survival.
The study is designed as a single-arm phase II study, with all patients accrued in one stage. No early stopping rules will be used.
- Conditions
- Colorectal Cancer
- Being tested
- chemotherapy
- Keywords
- advanced chemorefractory colorectal cancer, sorafenib, capecitabine, FDG-PET, early metabolic response
- Medical subject headings
- Colorectal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
chemotherapyDrug
Also called Xeloda, Nexavar
sorafenib 600mg/day capecitabine 1250 mg/m²/day
| Study group | Role | What they receive |
|---|---|---|
| Capecitabine & Sorafenib | Experimental | Sorafenib 200mg in the morning,400mg in the evening; escalation to 400mg twice daily after 1 cycle, Oral, Continuous dosing Capecitabine 850mg/m2 twice daily, Oral Days 1-14, weeks 1-2 Receives: Drug: chemotherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Overall survival at 6 months fixed endpoint
The 2 primary co-endpoints are :
- To obtain a preliminary assessment about the activity of the combination by estimating overall survival of the study population at a fixed time point (6 months)
- To compare as an exploratory analysis the overall survival of metabolic responders versus non-responders.
Measured: 6 months
Secondary outcomes (5)
To estimate the Progression Free Survival (PFS) distribution of the study population
Measured: 12 months
To determine the objective response rate of the study population as assessed by standard imaging
Measured: 12 months
To describe the adverse reactions associated with the study regimen in the study population.
Measured: 12 months
To determine the correlation of early metabolic response, as assessed by FDG-PET/CT immediately before the first and the second cycles of treatment with the study regimen, with overall survival, progression-free survival, and response.
Measured: 12 months
To determine the correlation of growth modulation index (GMI), defined as the time to progression under the study regimen over the time to progression un-der the latest prior regimen administered to the patient, with overall survival and progression-free
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Feb 2011 (estimated)
- Study startFeb 2011
- Primary completionJan 2016
- Study completionJan 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Colorectal CancerStudies of the same condition, open and under way.
- 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 97 participants (actual)
Sponsor and investigators
- Lead sponsor
- Jules Bordet Institute
- Sponsor type
- University, hospital or other
- Collaborators
- Erasme University Hospital, INDC Entité Jolimontoise, Centre Hospitalier Chretien, Universiteit Antwerpen, Cliniques universitaires Saint-Luc- Université Catholique de Louvain, Hospital Ambroise Paré Paris
- Responsible party
- Sponsor
- Investigators
- Alain Hendlisz, MD, Principal investigator, Jules Bordet Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01290926
- Sponsor's protocol ID
- EudraCT 2010-023695-91
- Acronym
- SoMore
- Status last verified
- Feb 2016
- First submitted
- 4 Feb 2011
- Last updated
- 24 Feb 2016
- Results posted
- No
- Data monitoring committee
- No
Publications
Charette N, Vandeputte C, Ameye L, Bogaert CV, Krygier J, Guiot T, Deleporte A, Delaunoit T, Geboes K, Van Laethem JL, Peeters M, Demolin G, Holbrechts S, Flamen P, Paesmans M, Hendlisz A. Prognostic value of adipose tissue and muscle mass in advanced colorectal cancer: a post hoc analysis of two non-randomized phase II trials. BMC Cancer. 2019 Feb 12;19(1):134. doi: 10.1186/s12885-019-5319-8.
PubMed 30744591Hendlisz A, Deleporte A, Delaunoit T, Marechal R, Peeters M, Holbrechts S, Van den Eynde M, Houbiers G, Filleul B, Van Laethem JL, Ceyssens S, Barbuto AM, Lhommel R, Demolin G, Garcia C, El Mansy H, Ameye L, Moreau M, Guiot T, Paesmans M, Piccart M, Flamen P. The Prognostic Significance of Metabolic Response Heterogeneity in Metastatic Colorectal Cancer. PLoS One. 2015 Sep 30;10(9):e0138341. doi: 10.1371/journal.pone.0138341. eCollection 2015.
PubMed 26421426
Study at a glance
From the registry record, last updated by the sponsor on 24 Feb 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Sorafenib Plus Capecitabine Efficacy Assessment in Patients With Advanced Pre-treated Colorectal Cancer
- ClinicalTrials.gov ID
- NCT01290926
- Acronym / sponsor ID
- SoMore / EudraCT 2010-023695-91
- Conditions
- Colorectal Cancer
- Keywords
- advanced chemorefractory colorectal cancer, sorafenib, capecitabine, FDG-PET, early metabolic response
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 97 participants (actual)
- Lead sponsor
- Jules Bordet InstituteUniversity, hospital or other
- Collaborators
- Erasme University Hospital, INDC Entité Jolimontoise, Centre Hospitalier Chretien, Universiteit Antwerpen, Cliniques universitaires Saint-Luc- Université Catholique de Louvain, Hospital Ambroise Paré Paris
- Study start
- Feb 2011
- Primary completion
- Jan 2016 (actual)
- Study completion
- Jan 2016 (actual)
- First posted
- 7 Feb 2011 (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.
Prospective non-randomized phase II study assessing the activity of the Capecitabine-Sorafenib combination by estimating overall survival of the study population at a fixed time point (6 months) and, as an exploratory analysis the overall survival of metabolic responders versus non-responders.
Detailed description
Treatment doses :
Sorafenib 200mg in the morning,400mg in the evening; escalation to 400mg twice daily after 1 cycle Capecitabine 850mg/m2 twice daily Oral Days 1-14, weeks 1-2
Fluoro-Deoxy Glucose Positron Emitting Tomography (FDG-PET)imaging at baseline and after 17-21 days while on therapy.
Sample size justification/statistical analysis
Sample size has been estimated in order to be able to test the null hypothesis that the overall survival rate at 6 months is less than 30%. This hypothesis will be tested using a binomial distribution. The study should be able to reject the null hypothesis, using a 1-sided test with α = 0.025, with a power of 90% in case of a true overall survival ≥ 50% (rate at 6 months). The sample size required is 66 eligible patients (to be followed for 6 months minimum). Analysis will be done on all registered patients using an ITT approach on all eligible patients.
A co-primary endpoint is to compare the overall survival of patients assessed as early PET responders and of patients assessed as early PET non responders (the clinicians will remain blinded for PET response assessment). For this primary analysis, patients who will undergo the second PET assessment will be eligible and time zero for measuring survival will be the date of this second PET examination. It is anticipated that 95% of the patients will be eligible for the analysis with a 50% expected rate of early PET non-responders (result obtained from an unpublished study conducted at Jules-Bordet Institute). With 66 patients registered, we anticipate then that 63 patients will be available for the co-primary endpoint. With 63 patients and our assumption that the HR for the comparison between the survival distributions will be around 0.385 (based on the previously mentioned unpublished study), we will need using a two-sided logrank test at the 2.5% level (2.5% chosen because of the existence of 2 co-primary endpoints), 54 events (power of 90%). With 63 patients and a follow-up after accrual of 1 year, we should reach this number of 54 events. However, to account for another possible 5% drop-out (patient's refusal for undergoing the second PET examination for instance), sample size should be increased to 70 eligible patients.
However, our estimation of 50% expected rate of early PET responders is coming from a prospective unicentric cohort of 38 patients undergoing chemotherapy for 1st line or 2nd line treatment of advanced colorectal cancer with a few of them having received biological agents together with chemotherapy. Our estimation may then not be reliable due to small sample size and different patients population. If this rate of early PET responders proves to be higher, we should be prepared to increase our sample size for targeting the same power of 90%. For instance, if the rate is 67% instead of 50%, the required number of events would be 62 in-stead of 54. If the rate is 75%, the number of events should be increased to 73. The number of patients would have then to be adapted according to the rate of evaluable patients for this PET objective and the rate of patients lost to follow-up. For reassessing the required numbers of events, we did not change our hypothesis of detecting, if true, a hazard ratio of 0.385 in favor of early PET responders.
We plan, during the course of accrual, to assess the rate of patients evaluable for the PET objective, of early PET responders and, if possible the rate of patients lost to follow-up in order to check whether we need to review our planned sample size. However, no interim analysis will be done on the primary endpoints.
Secondary endpoints are to estimate progression-free survival and objective response rate, and to describe the adverse reactions associated with the study regimen in the study population. Also, to determine the correlation of early metabolic response, as assessed by FDG-PET/CT immediately before the first and the second cycles of treatment with the study regimen, with overall survival, progression-free survival, and response rate, and to determine the correlation of growth modulation index (GMI), defined as the time to progression under the study regimen over the time to progression under the latest regimen administered to the patient, with overall survival and progression-free survival.
The study is designed as a single-arm phase II study, with all patients accrued in one stage. No early stopping rules will be used.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Capecitabine & Sorafenib | Experimental | Drug: chemotherapySorafenib 200mg in the morning,400mg in the evening; escalation to 400mg twice daily after 1 cycle, Oral, Continuous dosing Capecitabine 850mg/m2 twice daily, Oral Days 1-14, weeks 1-2 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (14 listed)
- Participants must have histologically confirmed colorectal cancer that is metastatic or unresectable and for which standard curative or palliative measures do not exist or are no longer effective.
- All standard chemotherapy agents (fluoropyrimidines, irinotecan, and oxaliplatin) and monoclonal antibodies (bevacizumab, cetuximab, and panitumumab) are allowed as administered therapy before study entry. No more than two lines of treatment for metastatic or recurrent disease are allowed, except for patients with KRAS-wt tumors, for which third line with anti-EGFR agents is allowed.
- Age over 18 years.
- Life expectancy of greater than 12 weeks.
- ECOG performance status ≤ 1.
Key exclusion criteria (11 listed)
- Participants who exhibit any of the following conditions at screening will not be eligible for admission into the study.
- Participants who have had chemotherapy or radiotherapy within 4 weeks prior to entering the study or those who have not recovered from adverse events due to agents administered more than 4 weeks earlier.
- Participants may not be receiving any other experimental agents.
- Participants with known brain metastases should be excluded from this clinical trial because of their poor prognosis and because they often develop progressive neurologic dysfunction that would confound the evaluation of neurologic and other adverse events.
- History of allergic reactions attributed to compounds of similar chemical or biologic composition to sorafenib or capecitabine.
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 |
|---|---|---|
| chemotherapyAlso: Xeloda, Nexavarsorafenib 600mg/day capecitabine 1250 mg/m²/day | Drug | Capecitabine & Sorafenib |
Primary outcome
Overall survival at 6 months fixed endpoint
Time frame: 6 months
The 2 primary co-endpoints are : 1. To obtain a preliminary assessment about the activity of the combination by estimating overall survival of the study population at a fixed time point (6 months) 2. To compare as an exploratory analysis the overall survival of metabolic responders versus non-responders.
5 secondary outcomes
To estimate the Progression Free Survival (PFS) distribution of the study population
Time frame: 12 months
To determine the objective response rate of the study population as assessed by standard imaging
Time frame: 12 months
To describe the adverse reactions associated with the study regimen in the study population.
Time frame: 12 months
To determine the correlation of early metabolic response, as assessed by FDG-PET/CT immediately before the first and the second cycles of treatment with the study regimen, with overall survival, progression-free survival, and response.
Time frame: 12 months
To determine the correlation of growth modulation index (GMI), defined as the time to progression under the study regimen over the time to progression un-der the latest prior regimen administered to the patient, with overall survival and progression-free
Time frame: 12 months
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 24 Feb 2016.
- Derived from this study: PubMed 30744591Charette N, Vandeputte C, Ameye L, Bogaert CV, Krygier J, Guiot T, Deleporte A, Delaunoit T, Geboes K, Van Laethem JL, Peeters M, Demolin G, Holbrechts S, Flamen P, Paesmans M, Hendlisz A. Prognostic value of adipose tissue and muscle mass in advanced colorectal cancer: a post hoc analysis of two non-randomized phase II trials. BMC Cancer. 2019 Feb 12;19(1):134. doi: 10.1186/s12885-019-5319-8.
- Derived from this study: PubMed 26421426Hendlisz A, Deleporte A, Delaunoit T, Marechal R, Peeters M, Holbrechts S, Van den Eynde M, Houbiers G, Filleul B, Van Laethem JL, Ceyssens S, Barbuto AM, Lhommel R, Demolin G, Garcia C, El Mansy H, Ameye L, Moreau M, Guiot T, Paesmans M, Piccart M, Flamen P. The Prognostic Significance of Metabolic Response Heterogeneity in Metastatic Colorectal Cancer. PLoS One. 2015 Sep 30;10(9):e0138341. doi: 10.1371/journal.pone.0138341. eCollection 2015.
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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.
Alain Hendlisz, MD principal investigator
Jules Bordet Institute
7 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing chemotherapy in people with Colorectal Cancer, run by Jules Bordet Institute at 7 sites in Belgium.
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 14 inclusion and 11 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 24 Feb 2016. 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. 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?
Overall survival at 6 months fixed endpoint (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01290926, which also lists 2 linked publications.
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 24 Feb 2016.