Rectal CarcinomaNCT01751516
PET/MRI as a Predictor of Response to Pre-op Chemoradiation in Resectable Rectal Cancer: a Pilot Study
An observational study of Rectal Carcinoma, run by UNC Lineberger Comprehensive Cancer Center at 1 site in United States.
Trial summary
This is a single arm, single center pilot study of 40 patients with uT3N0 or uT1-3N+ rectal cancer receiving pre-operative chemoradiation. Subjects will undergo PET/MRI scans before and after surgery. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Rectal Carcinoma
- How many people
- 8 participants
- Where
- 1 siteUnited States
- Study dates
- Oct 2012to 4 Mar 2018
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: UNC Hospitals
Who may be able to join
- Low-lying, low- to moderate-risk pathologically-confirmed rectal cancer (stage uT3n) or uT1-3N+
- Negative workup for distant disease
- > 18 years of age
- Pre-treatment workup completed including:
- history and physical
- CT or MRI of the abdomen and pelvis
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- endoscopic tumor evaluation (biopsy, blood work to assess CEA and hematopoietic, renal and liver function)
- if female of child-bearing age, negative pregnancy test
- Recommendation to undergo preoperative concurrent chemoradiation, as determined by the treating physician
- Informed consent reviewed and signed
Who cannot join
- Not deemed a candidate for preoperative chemoradiation for medical reasons, such as uncontrolled infection (including HIV), uncontrolled diabetes mellitus or cardiac disease
- Hemoglobin ≤ 10.0 g/dL (transfusion allowed to achieve or maintain levels)
- ANC ≤ 1,500/cubic mm³
- Platelet count ≤ 100,000/mm³
- ALT and AST ≥ 2.5 times upper level of normal (ULN)
- Alkaline phosphatase ≥ 2.5 times ULN
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- Total bilirubin ≥ 1.5 times ULN
- Creatinine clearance < 50 mL/min
- Creatinine ≥ 1.5 times ULN
- Not deemed a candidate for concurrent preoperative chemoradiation for social reasons, such as psychiatric illness
- Not deemed a surgical candidate
- Currently active second malignancy, except non-melanoma skin cancer, non-invasive bladder cancer, low risk adenocarcinoma of the prostate and carcinoma in situ of the cervix
- Previous pelvic radiation therapy
- History of severe reaction to gadolinium
- Inability to tolerate MRI (e.g., inability to lie flat for > 1 hour)
- Presence of a pacemaker, intracranial aneurysm clip, bladder stimulator, cochlear implant or metal near eyes
- Body Mass Index (BMI) > 35
- Pregnant or lactating female
Trial locations and contacts
1 site in 1 country.
United States1 site
University of North Carolina-Chapel Hill
Chapel Hill, North Carolina, 27599
About this study
Official title: PET/MRI as a Predictor for Response to Preoperative Radiation Therapy and Chemotherapy in Resectable Rectal Cancer: a Pilot Study.
This is a single arm, single center pilot study of 40 patients with uT3N0 or uT1-3N+ rectal cancer receiving pre-operative chemoradiation. Subjects will undergo PET/MRI scans before and after surgery.
Read the detailed description
The primary purpose of this study is to determine the negative predictive value of PET/MRI for determining pathological complete response from neoadjuvant chemoradiation.
- Conditions
- Rectal Carcinoma
- Medical subject headings
- Rectal Neoplasms
What is being measured
The primary outcome is the main question the study is designed to answer.
Negative post-chemoradiation PET/MRI scan, as correlated with surgical pathology
Measured: 4-8 weeks post-chemoradiation
Secondary outcomes (3)
Recurrence-free survival
Measured: 5 years
Disease-specific survival
Measured: 5 years
Overall survival
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 posted18 Dec 2012 (estimated)
- Study startOct 2012
- Primary completionAug 2014
- Study completion4 Mar 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Rectal CarcinomaStudies of the same condition, open and under way.
- More trials run by UNC Lineberger Comprehensive Cancer CenterThe 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
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 8 participants (actual)
Sponsor and investigators
- Lead sponsor
- UNC Lineberger Comprehensive Cancer Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Joel E Tepper, MD, Principal investigator, University of North Carolina, Chapel Hill
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01751516
- Sponsor's protocol ID
- LCCC1225
- Status last verified
- Jan 2021
- First submitted
- 13 Dec 2012
- Last updated
- 29 Jan 2021
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 29 Jan 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- PET/MRI as a Predictor for Response to Preoperative Radiation Therapy and Chemotherapy in Resectable Rectal Cancer: a Pilot Study.
- ClinicalTrials.gov ID
- NCT01751516
- Acronym / sponsor ID
- LCCC1225
- Conditions
- Rectal Carcinoma
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 8 participants (actual)
- Lead sponsor
- UNC Lineberger Comprehensive Cancer CenterUniversity, hospital or other
- Study start
- Oct 2012 (actual)
- Primary completion
- Aug 2014 (actual)
- Study completion
- 4 Mar 2018 (actual)
- First posted
- 18 Dec 2012 (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.
This is a single arm, single center pilot study of 40 patients with uT3N0 or uT1-3N+ rectal cancer receiving pre-operative chemoradiation. Subjects will undergo PET/MRI scans before and after surgery.
Detailed description
The primary purpose of this study is to determine the negative predictive value of PET/MRI for determining pathological complete response from neoadjuvant chemoradiation.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- UNC Hospitals
Key inclusion criteria (10 listed)
- Low-lying, low- to moderate-risk pathologically-confirmed rectal cancer (stage uT3n) or uT1-3N+
- Negative workup for distant disease
- > 18 years of age
- Pre-treatment workup completed including:
- history and physical
Key exclusion criteria (18 listed)
- Not deemed a candidate for preoperative chemoradiation for medical reasons, such as uncontrolled infection (including HIV), uncontrolled diabetes mellitus or cardiac disease
- Hemoglobin ≤ 10.0 g/dL (transfusion allowed to achieve or maintain levels)
- ANC ≤ 1,500/cubic mm³
- Platelet count ≤ 100,000/mm³
- ALT and AST ≥ 2.5 times upper level of normal (ULN)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Negative post-chemoradiation PET/MRI scan, as correlated with surgical pathology
Time frame: 4-8 weeks post-chemoradiation
3 secondary outcomes
Recurrence-free survival
Time frame: 5 years
Disease-specific survival
Time frame: 5 years
Overall survival
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 29 Jan 2021.
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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.
Joel E Tepper, MD principal investigator
University of North Carolina, Chapel Hill
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 Rectal Carcinoma, run by UNC Lineberger Comprehensive Cancer Center 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?
The sponsor lists 10 inclusion and 18 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 29 Jan 2021. 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 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?
Negative post-chemoradiation PET/MRI scan, as correlated with surgical pathology (time frame: 4-8 weeks post-chemoradiation). 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 Jan 2021.