Colon CancerNCT01310972
Adjuvant Colon Cancer w/ ELOXatin®/5 FU Based Regimen: ACCELOX
An observational study of Colon Cancer, run by King Faisal Specialist Hospital & Research Center at 1 site in Saudi Arabia.
Trial summary
Adjuvant Colon Cancer With ELOXatin®/5 FU Based Regimen: ACCELOX Read more about this study
- Who is it for?
- Ages 14 to 85 years
- Conditions the study is for
- Colon Cancer
- What is being tested?
- Registry
- How many people
- 6 participants
- Where
- 1 siteSaudi Arabia
- Study dates
- Sep 2007to Sep 2007
- 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: Colon Cancer Registry
Who may be able to join
- Patients with Adjuvant Colon Cancer
Who cannot join
- Patients with diagnosis other than Colon Cancer.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Adjuvant Colon Cancer With ELOXatin®/5 FU Based Regimen: ACCELOX
Adjuvant Colon Cancer With ELOXatin®/5 FU Based Regimen: ACCELOX
Read the detailed description
It's a study of adjuvant colon carcinoma using ELOXatin/5-FU based chemotherapeutic regimen called ACCELOX as a definitive curative therapy.
- Conditions
- Colon Cancer
- Being tested
- Registry
- Keywords
- Adjuvant Colon Cancer
- Medical subject headings
- Colonic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RegistryOther
Registry
What is being measured
The primary outcome is the main question the study is designed to answer.
OS, PFS, DFS
Measured: For the duration of the experiment
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 startSep 2007
- Primary completionSep 2007
- Study completionSep 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Colon 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 6 participants (actual)
Sponsor and investigators
- Lead sponsor
- King Faisal Specialist Hospital & Research Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Al Jubran, M.D., Principal investigator, KFSH & RC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01310972
- Sponsor's protocol ID
- RAC# 2071-027
- Other IDs
- RAC# 2071-027
- Status last verified
- Aug 2018
- First submitted
- 6 Mar 2011
- Last updated
- 10 Aug 2018
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 10 Aug 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Adjuvant Colon Cancer With ELOXatin®/5 FU Based Regimen: ACCELOX
- ClinicalTrials.gov ID
- NCT01310972
- Acronym / sponsor ID
- RAC# 2071-027
- Conditions
- Colon Cancer
- Keywords
- Adjuvant Colon Cancer
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 6 participants (actual)
- Lead sponsor
- King Faisal Specialist Hospital & Research CenterUniversity, hospital or other
- Study start
- Sep 2007
- Primary completion
- Sep 2007 (actual)
- Study completion
- Sep 2007 (actual)
- 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.
Adjuvant Colon Cancer With ELOXatin®/5 FU Based Regimen: ACCELOX
Detailed description
It's a study of adjuvant colon carcinoma using ELOXatin/5-FU based chemotherapeutic regimen called ACCELOX as a definitive curative therapy.
Study design
- Observational model
- Cohort
- 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
- Colon Cancer Registry
Key inclusion criteria (1 listed)
- Patients with Adjuvant Colon Cancer
Key exclusion criteria (1 listed)
- Patients with diagnosis other than Colon 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 |
|---|---|---|
| RegistryRegistry | Other | – |
Primary outcome
OS, PFS, DFS
Time frame: For the duration of the experiment
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 10 Aug 2018.
- Individual participant dataSharing planned: Undecided
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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.
Al Jubran, 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 Colon 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: finished, as of the sponsor's last update on 10 Aug 2018. 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?
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?
OS, PFS, DFS (time frame: For the duration of the experiment). 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 10 Aug 2018.