Metastatic Colorectal CancerNCT01311050
A Trial of Capecitabine (Xeloda), Oxaliplatin and Irinotecan in Combination With Bevacizumab in 1st Line Treatment of Metastatic Colorectal Cancer
An observational study of Metastatic Colorectal Cancer, run by King Faisal Specialist Hospital & Research Center at 1 site in Saudi Arabia.
Trial summary
A Phase I-II Trial of Capecitabine (Xeloda), Oxaliplatin and Irinotecan in Combination with Bevacizumab in 1st Line Treatment of Metastatic Colorectal Cancer Read more about this study
- Who is it for?
- Ages 14 to 85 years
- Conditions the study is for
- Metastatic Colorectal Cancer
- What is being tested?
- Capecitabine (Xeloda), Oxaliplatin, Irinotecan, Bevacizumab
- How many people
- 46 participants
- Where
- 1 siteSaudi Arabia
- Study dates
- Jan 2009to not given
- Phase
- Observational
- 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 14 to 85 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Metastatic Colorectal Cancer
Who may be able to join
- Patients with diagnosed Metastatic Colorectal Cancer
Who cannot join
- Patients with diagnosis other than Metastatic Colorectal Cancer
Trial locations and contacts
1 site in 1 country.
Shouki Bazarbashi, M.D. contact
About this study
Official title: A Phase I-II Trial of Capecitabine (Xeloda), Oxaliplatin and Irinotecan in Combination With Bevacizumab in 1st Line Treatment of Metastatic Colorectal Cancer
A Phase I-II Trial of Capecitabine (Xeloda), Oxaliplatin and Irinotecan in Combination with Bevacizumab in 1st Line Treatment of Metastatic Colorectal Cancer
Read the detailed description
A Phase I-II Trial of Capecitabine (Xeloda), Oxaliplatin and Irinotecan in Combination with Bevacizumab in 1st Line Treatment of Metastatic Colorectal Cancer
- Conditions
- Metastatic Colorectal Cancer
- Being tested
- Capecitabine (Xeloda), Oxaliplatin, Irinotecan, Bevacizumab
- Keywords
- Metastatic Colorectal Cancer
- Medical subject headings
- Colorectal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Capecitabine (Xeloda), Oxaliplatin, Irinotecan, BevacizumabDrug
Capecitabine (Xeloda), Oxaliplatin, Irinotecan, Bevacizumab
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Mar 2011 (estimated)
- Study startJan 2009
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 Metastatic 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
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 46 participants (estimated)
Sponsor and investigators
- Lead sponsor
- King Faisal Specialist Hospital & Research Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Shouki Bazarbashi, M.D., Principal investigator, KFSH & RC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01311050
- Sponsor's protocol ID
- RAC# 2081-068
- Other IDs
- RAC# 2081-068
- Status last verified
- Dec 2011
- First submitted
- 6 Mar 2011
- Last updated
- 13 Dec 2011
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Elshenawy MA, Badran A, Aljubran A, Alzahrani A, Rauf MS, Eldali A, Bazarbashi S. Survival benefit of surgical resection after first-line triplet chemotherapy and bevacizumab in patients with initially unresectable metastatic colorectal cancer. World J Surg Oncol. 2020 Jul 8;18(1):163. doi: 10.1186/s12957-020-01930-8.
PubMed 32641137Bazarbashi S, Aljubran A, Alzahrani A, Mohieldin A, Soudy H, Shoukri M. Phase I/II trial of capecitabine, oxaliplatin, and irinotecan in combination with bevacizumab in first line treatment of metastatic colorectal cancer. Cancer Med. 2015 Oct;4(10):1505-13. doi: 10.1002/cam4.497. Epub 2015 Jul 24.
PubMed 26207614
Study at a glance
From the registry record, last updated by the sponsor on 13 Dec 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I-II Trial of Capecitabine (Xeloda), Oxaliplatin and Irinotecan in Combination With Bevacizumab in 1st Line Treatment of Metastatic Colorectal Cancer
- ClinicalTrials.gov ID
- NCT01311050
- Acronym / sponsor ID
- RAC# 2081-068
- Conditions
- Metastatic Colorectal Cancer
- Keywords
- Metastatic Colorectal Cancer
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 46 participants (estimated)
- Lead sponsor
- King Faisal Specialist Hospital & Research CenterUniversity, hospital or other
- Study start
- Jan 2009
- First posted
- 9 Mar 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.
A Phase I-II Trial of Capecitabine (Xeloda), Oxaliplatin and Irinotecan in Combination with Bevacizumab in 1st Line Treatment of Metastatic Colorectal Cancer
Detailed description
A Phase I-II Trial of Capecitabine (Xeloda), Oxaliplatin and Irinotecan in Combination with Bevacizumab in 1st Line Treatment of Metastatic Colorectal Cancer
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
Who may qualify
- Ages
- 14 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Metastatic Colorectal Cancer
Key inclusion criteria (1 listed)
- Patients with diagnosed Metastatic Colorectal Cancer
Key exclusion criteria (1 listed)
- Patients with diagnosis other than Metastatic Colorectal 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 |
|---|---|---|
| Capecitabine (Xeloda), Oxaliplatin, Irinotecan, BevacizumabCapecitabine (Xeloda), Oxaliplatin, Irinotecan, Bevacizumab | Drug | – |
Primary outcome
Not reported in the source record.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Dec 2011.
- Derived from this study: PubMed 32641137Elshenawy MA, Badran A, Aljubran A, Alzahrani A, Rauf MS, Eldali A, Bazarbashi S. Survival benefit of surgical resection after first-line triplet chemotherapy and bevacizumab in patients with initially unresectable metastatic colorectal cancer. World J Surg Oncol. 2020 Jul 8;18(1):163. doi: 10.1186/s12957-020-01930-8.
- Derived from this study: PubMed 26207614Bazarbashi S, Aljubran A, Alzahrani A, Mohieldin A, Soudy H, Shoukri M. Phase I/II trial of capecitabine, oxaliplatin, and irinotecan in combination with bevacizumab in first line treatment of metastatic colorectal cancer. Cancer Med. 2015 Oct;4(10):1505-13. doi: 10.1002/cam4.497. Epub 2015 Jul 24.
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CRC
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.
Shouki Bazarbashi, M.D. contact
Shouki Bazarbashi, M.D. principal investigator
KFSH & RC
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Metastatic Colorectal Cancer, run by King Faisal Specialist Hospital & Research Center at 1 site in Saudi Arabia.
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 1 inclusion and 1 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 13 Dec 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 Saudi Arabia. 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.
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?
Contact Shouki Bazarbashi, M.D. (+966-1-4423949), or a site near the patient. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01311050, 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 13 Dec 2011.