Rectal CancerNCT00394615
Metabolic Imaging Predict Histopathologic Response to Preop ChemoXRT for Locally Advanced Rectal CA
A study testing Metabolic Imaging in people with Rectal Cancer, run by Stanford University at 1 site in United States.
Trial summary
In this research study of metabolic imaging in locally advanced rectal cancer, we hope to learn whether new medical imaging technology can help predict the response of rectal cancer to preoperative chemotherapy and radiation therapy. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Rectal Cancer
- What is being tested?
- Metabolic Imaging
- Type of treatment
- Surgery or procedure
- How many people
- 15 participants
- Where
- 1 siteUnited States
- Study dates
- Oct 2003to Oct 2005
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Inclusion Criteria:- You must be diagnosed with locally advanced rectal cancer and have chosen treatment with preoperative chemoradiotherapy followed by surgery, which is a standard treatment approach for this disease. Exclusion Criteria:- You are ineligible for this study if you are pregnant or under the age of 18 years old.
Trial locations and contacts
1 site in 1 country.
United States1 site
Stanford University School of Medicine
Stanford, California, 94305
About this study
Official title: Metabolic Imaging: Predicting Histopathologic Response to Preoperative Chemoradiotherapy for Locally Advanced Rectal Cancer
In this research study of metabolic imaging in locally advanced rectal cancer, we hope to learn whether new medical imaging technology can help predict the response of rectal cancer to preoperative chemotherapy and radiation therapy. Ultimately we hope this information will in the future help us predict which patients will benefit from more or less aggressive initial therapy for their rectal cancer.
- Conditions
- Rectal Cancer
- Being tested
- Metabolic Imaging
- Medical subject headings
- Rectal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Metabolic ImagingProcedure or surgery
What is being measured
The primary outcome is the main question the study is designed to answer.
To learn whether new medical imaging technology can help predict the response of rectal cancer to preoperative chemotherapy and radiation therapy.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Nov 2006 (estimated)
- Study startOct 2003
- Primary completionOct 2005
- Study completionOct 2005
Why it stopped: Protocol approval expired
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.
- More trials run by Stanford UniversityThe sponsor's other registered studies.
- 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
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 15 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Stanford University
- Sponsor type
- University, hospital or other
- Collaborators
- Stanford Cancer Council
- Investigators
- Albert Koong, Principal investigator, Stanford University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00394615
- Sponsor's protocol ID
- REC0001
- Other IDs
- NCT00394615, REC0001
- Status last verified
- Mar 2010
- First submitted
- 5 Jul 2006
- Last updated
- 29 Mar 2010
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Mar 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Metabolic Imaging: Predicting Histopathologic Response to Preoperative Chemoradiotherapy for Locally Advanced Rectal Cancer
- ClinicalTrials.gov ID
- NCT00394615
- Acronym / sponsor ID
- REC0001
- Conditions
- Rectal Cancer
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Protocol approval expired
- Enrolment
- 15 participants (estimated)
- Lead sponsor
- Stanford UniversityUniversity, hospital or other
- Collaborators
- Stanford Cancer Council
- Study start
- Oct 2003
- Primary completion
- Oct 2005 (actual)
- Study completion
- Oct 2005 (actual)
- First posted
- 1 Nov 2006 (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.
In this research study of metabolic imaging in locally advanced rectal cancer, we hope to learn whether new medical imaging technology can help predict the response of rectal cancer to preoperative chemotherapy and radiation therapy. Ultimately we hope this information will in the future help us predict which patients will benefit from more or less aggressive initial therapy for their rectal cancer.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
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 |
|---|---|---|
| Metabolic Imaging | Procedure or surgery | – |
Primary outcome
To learn whether new medical imaging technology can help predict the response of rectal cancer to preoperative chemotherapy and radiation therapy.
Results and safety
The study was stopped early (reason given: Protocol approval expired). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Mar 2010.
Related trials for Rectal Cancer
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.
Albert Koong principal investigator
Stanford University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Metabolic Imaging in people with Rectal Cancer, run by Stanford University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
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: stopped early, as of the sponsor's last update on 29 Mar 2010. 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 United States. 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 was stopped early (reason given: Protocol approval expired). 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?
To learn whether new medical imaging technology can help predict the response of rectal cancer to preoperative chemotherapy and radiation therapy.. 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 29 Mar 2010.