Colon Rectal Cancer Duke Stage StagevalNCT01310985
A Trial of Pre-Operative Chemoradiotherapy Using Capecitabine, Radiation & Cetuximab, in Rectal Cancer
An observational study of Colon Rectal Cancer Duke Stage Stageval, run by King Faisal Specialist Hospital & Research Center at 1 site in Saudi Arabia.
Trial summary
A Pilot Trial of Pre-Operative Chemoradiotherapy Using Capecitabine (Xelodaâ), External Beam Radiation and Cetuximab (Erbitux®) Followed by Definitive Surgery in Patients With Localized (Non-Metastatic) Rectal Cancer Read more about this study
- Who is it for?
- Ages 14 to 85 years
- Conditions the study is for
- Colon Rectal Cancer Duke Stage Stageval
- What is being tested?
- Capecitabine (Xelodaâ), XRT & Cetuximab (Erbitux®)
- How many people
- 15 participants
- Where
- 1 siteSaudi Arabia
- Study dates
- Mar 2008to Aug 2014
- 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: Patients with Localized (Non-Metastatic) Rectal Cancer
Who may be able to join
- Patients with Localized Non-Metastatic Rectal Cancer
Who cannot join
- Patients with diagnosis other than Localized Non-Metastatic Rectal Cancer
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Pilot Trial of Pre-Operative Chemoradiotherapy Using Capecitabine (Xelodaâ), External Beam Radiation and Cetuximab (Erbitux®) Followed by Definitive Surgery in Patients With Localized (Non-Metastatic) Rectal Cancer
A Pilot Trial of Pre-Operative Chemoradiotherapy Using Capecitabine (Xelodaâ), External Beam Radiation and Cetuximab (Erbitux®) Followed by Definitive Surgery in Patients With Localized (Non-Metastatic) Rectal Cancer
Read the detailed description
Its a pilot study of pre-op chemotherapy and RT utilizing CAPECITABINE, XRT and CETUXIMAB in pts with locally advanced rectal carcinoma.
- Conditions
- Colon Rectal Cancer Duke Stage Stageval
- Being tested
- Capecitabine (Xelodaâ), XRT & Cetuximab (Erbitux®)
- Keywords
- Rectal Cancer
- Medical subject headings
- Rectal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Capecitabine (Xelodaâ), XRT & Cetuximab (Erbitux®)Drug
Also called Capecitabine (Xelodaâ), XRT& Cetuximab (Erbitux®)
Capecitabine (Xelodaâ), External Beam Radiation and Cetuximab (Erbitux®)
What is being measured
The primary outcome is the main question the study is designed to answer.
Evaluate the safety of pre-operative concurrent chemotherapy with capacitabine (Xeloda), weekly cetuximab (Erbitux), and external beam radiation.
Measured: For the duration of the experiment
Secondary outcomes (1)
Evaluate efficacy of sphincter preserving surgery rate, local recurrence rate and the disease free and overall survival in patients.
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 startMar 2008
- Primary completionAug 2014
- Study completionAug 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Colon Rectal Cancer Duke Stage StagevalStudies 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
- Cross-sectional
- Enrolment
- 15 participants (actual)
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
- NCT01310985
- Sponsor's protocol ID
- RAC# 2071-051
- Other IDs
- RAC# 2071-051
- Status last verified
- Dec 2011
- First submitted
- 6 Mar 2011
- Last updated
- 1 Mar 2019
- 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 1 Mar 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Pilot Trial of Pre-Operative Chemoradiotherapy Using Capecitabine (Xelodaâ), External Beam Radiation and Cetuximab (Erbitux®) Followed by Definitive Surgery in Patients With Localized (Non-Metastatic) Rectal Cancer
- ClinicalTrials.gov ID
- NCT01310985
- Acronym / sponsor ID
- RAC# 2071-051
- Conditions
- Colon Rectal Cancer Duke Stage Stageval
- Keywords
- Rectal Cancer
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 15 participants (actual)
- Lead sponsor
- King Faisal Specialist Hospital & Research CenterUniversity, hospital or other
- Study start
- Mar 2008
- Primary completion
- Aug 2014 (actual)
- Study completion
- Aug 2014 (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.
A Pilot Trial of Pre-Operative Chemoradiotherapy Using Capecitabine (Xelodaâ), External Beam Radiation and Cetuximab (Erbitux®) Followed by Definitive Surgery in Patients With Localized (Non-Metastatic) Rectal Cancer
Detailed description
Its a pilot study of pre-op chemotherapy and RT utilizing CAPECITABINE, XRT and CETUXIMAB in pts with locally advanced rectal carcinoma.
Study design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 14 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Patients with Localized (Non-Metastatic) Rectal Cancer
Key inclusion criteria (1 listed)
- Patients with Localized Non-Metastatic Rectal Cancer
Key exclusion criteria (1 listed)
- Patients with diagnosis other than Localized Non-Metastatic Rectal 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 (Xelodaâ), XRT & Cetuximab (Erbitux®)Also: Capecitabine (Xelodaâ), XRT& Cetuximab (Erbitux®)Capecitabine (Xelodaâ), External Beam Radiation and Cetuximab (Erbitux®) | Drug | – |
Primary outcome
Evaluate the safety of pre-operative concurrent chemotherapy with capacitabine (Xeloda), weekly cetuximab (Erbitux), and external beam radiation.
Time frame: For the duration of the experiment
1 secondary outcome
Evaluate efficacy of sphincter preserving surgery rate, local recurrence rate and the disease free and overall survival in patients.
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 1 Mar 2019.
- Individual participant dataSharing planned: Undecided
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. 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 Rectal Cancer Duke Stage Stageval, 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 1 Mar 2019. 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?
Evaluate the safety of pre-operative concurrent chemotherapy with capacitabine (Xeloda), weekly cetuximab (Erbitux), and external beam radiation. (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 1 Mar 2019.