Rectal NeoplasmsNCT00535041
Pilot Trial of Pre-operative Chemo/RT Using Xeloda and External Beam RT Followed by Definite Surgery in Patients With Localized Rectal CA
A study testing Chemotherapy, radiation therapy & surgery in people with Rectal Neoplasms, run by King Faisal Specialist Hospital & Research Center at 1 site in Saudi Arabia.
Trial summary
Pilot trial of pre-operative chemo/RT using Xeloda and external beam RT followed by definite surgery in patients with localized rectal CA Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Rectal Neoplasms
- What is being tested?
- Chemotherapy, radiation therapy & surgery
- How many people
- 200 participants
- Where
- 1 siteSaudi Arabia
- Study dates
- Sep 2007to Sep 2015
- Phase
- Interventional
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Patients with localized rectal CA
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
About this study
Pilot trial of pre-operative chemo/RT using Xeloda and external beam RT followed by definite surgery in patients with localized rectal CA
- Conditions
- Rectal Neoplasms
- Being tested
- Chemotherapy, radiation therapy & surgery
- Keywords
- Pilot trial of pre-operative chemo/RT using Xeloda and external beam RT followed by definite surgery in patients with localized rectal CA
- Medical subject headings
- Rectal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Chemotherapy, radiation therapy & surgeryDrug
radiation and chemotherapy
What is being measured
The primary outcome is the main question the study is designed to answer.
safety
Measured: 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Sep 2007 (estimated)
- Study startSep 2007
- Primary completionSep 2015
- Study completionSep 2015
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.
- 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 N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 200 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, MD, Principal investigator, KFSH&RC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00535041
- Sponsor's protocol ID
- RAC#2011-031
- Status last verified
- Jan 2016
- First submitted
- 21 Sep 2007
- Last updated
- 1 Mar 2019
- Results posted
- No
- Data monitoring committee
- Yes
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
- Pilot Trial of Pre-operative Chemo/RT Using Xeloda and External Beam RT Followed by Definite Surgery in Patients With Localized Rectal CA
- ClinicalTrials.gov ID
- NCT00535041
- Acronym / sponsor ID
- RAC#2011-031
- Conditions
- Rectal Neoplasms
- Keywords
- Pilot trial of pre-operative chemo/RT using Xeloda and external beam RT followed by definite surgery in patients with localized rectal CA
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 200 participants (actual)
- Lead sponsor
- King Faisal Specialist Hospital & Research CenterUniversity, hospital or other
- Study start
- Sep 2007
- Primary completion
- Sep 2015 (actual)
- Study completion
- Sep 2015 (actual)
- First posted
- 26 Sep 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.
Pilot trial of pre-operative chemo/RT using Xeloda and external beam RT followed by definite surgery in patients with localized rectal CA
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- Patients with localized rectal CA
Key exclusion criteria (0 listed)
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 |
|---|---|---|
| Chemotherapy, radiation therapy & surgeryradiation and chemotherapy | Drug | – |
Primary outcome
safety
Time frame: 5 years
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.
Related trials for Rectal Neoplasms
Not yet recruitingPhase 1
Hepatic Artery Infusion of Carfilzomib in Participants With Liver Metastatic Disease Previously Treated With Hepatic Artery Infusion Pump Therapy
Colorectal Neoplasms, Neoplasms
Active, not recruiting
Streamlined Geriatric and Oncological Evaluation Based On IC Technology
Breast Cancer, Comorbidities and Coexisting Conditions
RecruitingObservational study
Pre- and On-treatment Multi-omics Profiling of Locally Advanced Rectal Cancer
Rectal Neoplasms
Enrolling by invitationObservational study
Natural History Study of Early Life Exposures in Agriculture (ELEA)
Prostate Cancer, Leukemia
RecruitingPhase 2
Tislelizumab in People With Colorectal Cancer
Colorectal Cancer
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, MD 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?
A study testing Chemotherapy, radiation therapy & surgery in people with Rectal Neoplasms, 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 0 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?
safety (time frame: 5 years). 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.