Rectal CancerPhase 2NCT00122291
A Study of Preoperative Radiation Therapy and Capecitabine in Locally Advanced Rectal Cancer
A Phase 2 study testing Capecitabine and Pelvic radiation in people with Rectal Cancer and Neoplasm Metastasis, run by Alberta Health services at 1 site in Canada.
Trial summary
The purpose of this trial is to study the efficacy of preoperative radiation therapy and capecitabine in locally advanced rectal cancer. Read more about this study
- Who is it for?
- Ages 17 years and older
- Conditions the study is for
- Rectal Cancer, Neoplasm Metastasis
- What is being tested?
- Capecitabine and Pelvic radiation
- Type of treatment
- Surgery or procedure
- How many people
- 66 participants
- Where
- 1 siteCanada
- Study dates
- Jan 2002to not given
- 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 17 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Biopsy - proven rectal cancer
- Transmural rectal wall invasion
- Karnofsky performance status >70
- Normal bone marrow, liver and kidney function
Who cannot join
- Distant metastases
- Prior pelvic radiation
- Inflammatory bowel disease
- Severe ischemic heart disease
- Anticoagulant therapy
- Pregnancy
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Phase 2 Study of Preoperative Radiation Therapy and Capecitabine (an Oral Fluoropyrimidine Carbamate) in Locally Advanced Rectal Cancer
The purpose of this trial is to study the efficacy of preoperative radiation therapy and capecitabine in locally advanced rectal cancer.
Read the detailed description
The purpose of this trial is to study the efficacy of preoperative radiation therapy and capecitabine in locally advanced rectal cancer.
- Conditions
- Rectal Cancer, Neoplasm Metastasis
- Being tested
- Capecitabine, Pelvic radiation
- Keywords
- preoperative, chemotherapy, radiation therapy, rectal cancer, transmural rectal wall invasion, nodal metastasis
- Medical subject headings
- Rectal Neoplasms, Neoplasm Metastasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CapecitabineDrug
Pelvic radiationProcedure or surgery
What is being measured
The primary outcome is the main question the study is designed to answer.
safety
response
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jul 2005 (estimated)
- Study startJan 2002
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Rectal 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
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 66 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Alberta Health services
- Sponsor type
- University, hospital or other
- Investigators
- Gwyn Bebb, MD, Principal investigator, Alberta Health services
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00122291
- Sponsor's protocol ID
- 16080
- Other IDs
- Capecitabine Phase 2
- Status last verified
- Aug 2011
- First submitted
- 20 Jul 2005
- Last updated
- 19 Jan 2012
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Jan 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 2 Study of Preoperative Radiation Therapy and Capecitabine (an Oral Fluoropyrimidine Carbamate) in Locally Advanced Rectal Cancer
- ClinicalTrials.gov ID
- NCT00122291
- Acronym / sponsor ID
- 16080
- Conditions
- Rectal Cancer, Neoplasm Metastasis
- Keywords
- preoperative, chemotherapy, radiation therapy, rectal cancer, transmural rectal wall invasion, nodal metastasis
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 66 participants (estimated)
- Lead sponsor
- Alberta Health servicesUniversity, hospital or other
- Study start
- Jan 2002
- First posted
- 22 Jul 2005 (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.
The purpose of this trial is to study the efficacy of preoperative radiation therapy and capecitabine in locally advanced rectal cancer.
Detailed description
The purpose of this trial is to study the efficacy of preoperative radiation therapy and capecitabine in locally advanced rectal cancer.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 17 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (4 listed)
- Biopsy - proven rectal cancer
- Transmural rectal wall invasion
- Karnofsky performance status >70
- Normal bone marrow, liver and kidney function
Key exclusion criteria (6 listed)
- Distant metastases
- Prior pelvic radiation
- Inflammatory bowel disease
- Severe ischemic heart disease
- Anticoagulant therapy
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 | Drug | – |
| Pelvic radiation | Procedure or surgery | – |
Primary outcome
safety
response
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Jan 2012.
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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.
Gwyn Bebb, MD principal investigator
Alberta Health services
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Capecitabine and Pelvic radiation in people with Rectal Cancer and Neoplasm Metastasis, run by Alberta Health services at 1 site in Canada.
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 4 inclusion and 6 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 19 Jan 2012. 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 Canada. 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?
Results are not available in the source record.
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. The study lists 2 primary outcomes in all. 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 19 Jan 2012.