Anal Cancer PatientsNCT01053923
MRI for Tumor During Chemoradiation for Anal Canal and Perianal Cancer
An observational study of Anal Cancer Patients and Perianal Patients, run by University Health Network, Toronto.
Trial summary
The purpose of this study is to establish a prospective database of anal canal and perianal cancer patients treated with IMRT and chemotherapy with curative intent at PMH for the purposes of investigating MRI-derived primary tumor parameters. Read more about this study
- Who is it for?
- Ages 19 years and older
- Conditions the study is for
- Anal Cancer Patients, Perianal Patients
- What is being tested?
- Magnetic Resonance Imaging (MRI)
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- Dec 2009to Mar 2013
- 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 19 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with anal canal or perianal cancer
Who may be able to join
- histological confirmation of invasive primary squamous cell carcinoma or adenocarcinoma of the anal canal or perianal region
- treatment with curative intent
- patients who are not eligible for chemotherapy and receive IMRT alone are eligible for evaluation
- primary anal or perianal cancer evaluable on cross-sectional imaging (CT or MRI) scan
- ECOG performance status of 0, 1, or 2
- age > 18 years
- able to provide informed consent
Who cannot join
- evidence of distant metastasis (M1)
- prior radiation therapy to the pelvis or contraindication to radiotherapy
- contraindication to MRI imaging
- known allergy to intravenous Gadolinium
- renal insufficiency (serum creatinine greater than 150)
- serious claustrophobia
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- cardiac pacemaker
- hip prosthesis
- major medical or psychiatric illness which, in the investigator's opinion, would prevent completion of imaging study
About this study
Official title: A Feasibility Study of MRI in Assessment of Primary Tumor During Chemoradiation for Anal Canal and Perianal Cancer
The purpose of this study is to establish a prospective database of anal canal and perianal cancer patients treated with IMRT and chemotherapy with curative intent at PMH for the purposes of investigating MRI-derived primary tumor parameters. Patients who decide to participate in this study will be treated according to standard treatment policies and radiation therapy planning protocols at Princess Margaret Hospital (PMH) with radiation therapy +/- chemotherapy. IMRT for all treatment phases of radiotherapy has been implemented as standard treatment. Surgery is reserved for salvage treatment.
Read the detailed description
Anal cancer is an uncommon cancer, accounting for 2% of gastrointestinal cancers. Prognostic factors include tumor differentiation and staging, along with patient gender, race, and socioeconomic status. The standard of care is radical chemoradiation with 5-fluorouracil and mitomycin C, with surgery reserved for salvage. Intensity modulated radiation therapy (IMRT) is a specialized radiotherapy technique that may be used for anal cancer. IMRT allows the radiation dose to conform to the three-dimensional shape of the target volume more than conventional two-dimensional techniques, and it may reduce treatment toxicities without compromising tumor control. At the Princess Margaret Hospital (PMH) since July 2007, IMRT for all treatment phases of radiotherapy has been implemented as standard treatment for patients with anal canal and perianal cancer.
- Conditions
- Anal Cancer Patients, Perianal Patients
- Being tested
- Magnetic Resonance Imaging (MRI)
- Keywords
- Perianal Cancer, Anal Cancer, MRI scan
- Medical subject headings
- Anus Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Magnetic Resonance Imaging (MRI)Other
This study involves three imaging sessions (Magnetic Nuclear Resonance -MRI), with one session before radiation therapy and two sessions during radiation therapy (one at 3 weeks of RT; the other during the last week of RT). Each imaging session will last for approximately 45 to 60 minutes.
| Study group | Role | What they receive |
|---|---|---|
| MRI Scan | Not described Receives: Other: Magnetic Resonance Imaging (MRI) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Primary tumor dimensions at simulation and during week 3 and last week of fractionated radiotherapy from MRI
Measured: 12 months
Primary tumor perfusion coefficient at simulation and during week 3 and last week of fractionated radiotherapy from MRI
Measured: 12 months
Primary tumor apparent diffusion coefficient at simulation and during week 3 and last week of fractionated radiotherapy from MRI
Measured: 12 months
Secondary outcomes (3)
Change with time from start of radiotherapy course in primary tumor dimensions from MRI
Measured: 12 months
Change with time from start of radiotherapy course in primary tumor perfusion coefficient from MRI
Measured: 12 months
Change with time from start of radiotherapy course in primary tumor apparent diffusion coefficient from MRI
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jan 2010 (estimated)
- Study startDec 2009
- Primary completionMar 2013 (estimated)
- Study completionMar 2013 (estimated)
Why it stopped: Patient eligibility has limited accrual and patient sample has changed with the change in referral patients.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Anal Cancer PatientsStudies of the same condition, open and under way.
- More trials run by University Health Network, TorontoThe 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
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Health Network, Toronto
- Sponsor type
- University, hospital or other
- Collaborators
- Princess Margaret Hospital, Canada
- Responsible party
- Sponsor
- Investigators
- Robert Dinniwell, MD, Principal investigator, University Health Network, Princess Margaret Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01053923
- Sponsor's protocol ID
- UHN REB 09-0695-CE
- Status last verified
- Jun 2013
- First submitted
- 21 Jan 2010
- Last updated
- 13 Jun 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Jun 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Feasibility Study of MRI in Assessment of Primary Tumor During Chemoradiation for Anal Canal and Perianal Cancer
- ClinicalTrials.gov ID
- NCT01053923
- Acronym / sponsor ID
- UHN REB 09-0695-CE
- Conditions
- Anal Cancer Patients, Perianal Patients
- Keywords
- Perianal Cancer, Anal Cancer, MRI scan
- Study type
- Observational
- Recruitment status
- WithdrawnReason stopped: Patient eligibility has limited accrual and patient sample has changed with the change in referral patients.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- University Health Network, TorontoUniversity, hospital or other
- Collaborators
- Princess Margaret Hospital, Canada
- Study start
- Dec 2009
- Primary completion
- Mar 2013 (estimated)
- Study completion
- Mar 2013 (estimated)
- First posted
- 22 Jan 2010 (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 study is to establish a prospective database of anal canal and perianal cancer patients treated with IMRT and chemotherapy with curative intent at PMH for the purposes of investigating MRI-derived primary tumor parameters. Patients who decide to participate in this study will be treated according to standard treatment policies and radiation therapy planning protocols at Princess Margaret Hospital (PMH) with radiation therapy +/- chemotherapy. IMRT for all treatment phases of radiotherapy has been implemented as standard treatment. Surgery is reserved for salvage treatment.
Detailed description
Anal cancer is an uncommon cancer, accounting for 2% of gastrointestinal cancers. Prognostic factors include tumor differentiation and staging, along with patient gender, race, and socioeconomic status. The standard of care is radical chemoradiation with 5-fluorouracil and mitomycin C, with surgery reserved for salvage. Intensity modulated radiation therapy (IMRT) is a specialized radiotherapy technique that may be used for anal cancer. IMRT allows the radiation dose to conform to the three-dimensional shape of the target volume more than conventional two-dimensional techniques, and it may reduce treatment toxicities without compromising tumor control. At the Princess Margaret Hospital (PMH) since July 2007, IMRT for all treatment phases of radiotherapy has been implemented as standard treatment for patients with anal canal and perianal cancer.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| MRI Scan | – | Other: Magnetic Resonance Imaging (MRI) |
Who may qualify
- Ages
- 19 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with anal canal or perianal cancer
Key inclusion criteria (7 listed)
- histological confirmation of invasive primary squamous cell carcinoma or adenocarcinoma of the anal canal or perianal region
- treatment with curative intent
- patients who are not eligible for chemotherapy and receive IMRT alone are eligible for evaluation
- primary anal or perianal cancer evaluable on cross-sectional imaging (CT or MRI) scan
- ECOG performance status of 0, 1, or 2
Key exclusion criteria (9 listed)
- evidence of distant metastasis (M1)
- prior radiation therapy to the pelvis or contraindication to radiotherapy
- contraindication to MRI imaging
- known allergy to intravenous Gadolinium
- renal insufficiency (serum creatinine greater than 150)
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 |
|---|---|---|
| Magnetic Resonance Imaging (MRI)This study involves three imaging sessions (Magnetic Nuclear Resonance -MRI), with one session before radiation therapy and two sessions during radiation therapy (one at 3 weeks of RT; the other during the last week of RT). Each imaging session will last for approximately 45 to 60 minutes. | Other | MRI Scan |
Primary outcome
Primary tumor dimensions at simulation and during week 3 and last week of fractionated radiotherapy from MRI
Time frame: 12 months
Primary tumor perfusion coefficient at simulation and during week 3 and last week of fractionated radiotherapy from MRI
Time frame: 12 months
Primary tumor apparent diffusion coefficient at simulation and during week 3 and last week of fractionated radiotherapy from MRI
Time frame: 12 months
3 secondary outcomes
Change with time from start of radiotherapy course in primary tumor dimensions from MRI
Time frame: 12 months
Change with time from start of radiotherapy course in primary tumor perfusion coefficient from MRI
Time frame: 12 months
Change with time from start of radiotherapy course in primary tumor apparent diffusion coefficient from MRI
Time frame: 12 months
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Jun 2013.
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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.
Robert Dinniwell, MD principal investigator
University Health Network, Princess Margaret Hospital
Questions about this trial
What is this clinical trial studying?
An observational study of Anal Cancer Patients and Perianal Patients, run by University Health Network, Toronto.
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 7 inclusion and 9 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: withdrawn, as of the sponsor's last update on 13 Jun 2013. Status can change between updates, so confirm with the study contact before making plans.
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 withdrawn before enrolling participants, so there are no results.
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?
Primary tumor dimensions at simulation and during week 3 and last week of fractionated radiotherapy from MRI (time frame: 12 months). The study lists 3 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 13 Jun 2013.