Recurrent Rectal CancerNCT02528175
Magnetic Resonance-Guided High Intensity Focused Ultrasound for Recurrent Rectal Cancer
A study testing Magnetic resonance-guided focused ultrasound, Standard Radiation and Chemotherapy in people with Recurrent Rectal Cancer, run by William Chu, MD, MSc, FRCPC at 1 site in Canada.
Trial summary
This pilot study hypothesizes that hyperthermia delivered via magnetic resonance-guided focused ultrasound (MRg-FU) is technically feasible and can be safely used in combination with concurrent reirradiation and chemotherapy for the treatment of recurrent rectal cancer. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Recurrent Rectal Cancer
- What is being tested?
- Magnetic resonance-guided focused ultrasound, Standard Radiation and Chemotherapy
- Type of treatment
- Pill or oral medicine, Medical device, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 6 participants
- Where
- 1 siteCanada
- Study dates
- Apr 2015to Apr 2022
- 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
Who may be able to join
- Able to give informed consent
- Weight <140kg
- Biopsy-proven recurrent rectal adenocarcinoma
- Assessed by the treating surgeon, medical oncologist and radiation oncologist, and following a multidisciplinary discussion, determined to have unresectable and/or inoperable disease in the presence or absence of distant metastases
- Assessed by the treating radiation oncologist and medical oncologist determined to be fit for reirradiation and chemotherapy
- Prior pelvic radiotherapy
Show all 10Show fewer
- Target lesion visible by MR
- Target lesion accessible for MRg-FU procedure
- Target lesion maximum dimension ≤ 6cm
- Able to communicate sensation during MRg-FU treatment
Who cannot join
- Abdominal or pelvic surgery (excluding biopsy) ≤ 6 weeks prior to study enrolment
- Chemotherapy or other systemic anti-cancer agent ≤ 6 weeks prior to enrolment
- Previous radiotherapy ≤ 6 weeks prior to enrolment
- Recurrent tumour involves small bowel
- Unable to characterize pain
- Pregnant / Nursing woman
Show all 11Show fewer
- Orthopaedic implant along proposed MRg-FU beam path or at site of target lesion.
- Serious cardiovascular, neurological, renal or hematological chronic disease
- Active infection
- Unable to tolerate required stationary position during treatment
- Allergy to MR contrast agent or sedation
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Magnetic Resonance-Guided High Intensity Focused Ultrasound for Recurrent Rectal Cancer - A Pilot Study
This pilot study hypothesizes that hyperthermia delivered via magnetic resonance-guided focused ultrasound (MRg-FU) is technically feasible and can be safely used in combination with concurrent reirradiation and chemotherapy for the treatment of recurrent rectal cancer. Twenty recurrent rectal cancer patients who are not candidates for surgery will be recruited for hyperthermia treatment delivered via MRg-FU concurrent with reirradiation and oral chemotherapy.
Read the detailed description
Magnetic resonance-guided focused ultrasound (MRg-FU) is a non-invasive, outpatient modality being investigated for the thermal treatment of cancer. In MRg-FU, a specially designed transducer is used to focus a beam of low intensity ultrasound energy into a small volume at a specific target site in the body. MR is used to identify and delineate the tumour, focus the ultrasound beam on the target and provide real-time thermal mapping to ensure accurate heating of the designated target with minimal effect to the adjacent healthy tissue. The focused ultrasound beam produces therapeutic hyperthermia (40-42°C) in the target field causing protein denaturation and cell damage.
Currently, there is no prospective clinical data reported on the use of MRg-FU in the setting of recurrent rectal cancer. Recurrent rectal cancer is a vexing clinical problem. Current retreatment protocols have limited efficacy. The addition of hyperthermia to radiation and chemotherapy may enhance the therapeutic response. With recent advances in technology, the investigators hypothesize that MRg-FU is technically feasible and can be safely used in combination with concurrent reirradiation and chemotherapy for the treatment of recurrent rectal cancer without increased side-effects.
- Conditions
- Recurrent Rectal Cancer
- Being tested
- Magnetic resonance-guided focused ultrasound, Standard Radiation, Chemotherapy
- Medical subject headings
- Rectal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Magnetic resonance-guided focused ultrasoundDevice
Also called MRg-FU
Targeted warming of the tumor via 3 weekly MR-guided ultrasound procedures. Concurrent with radiation and chemotherapy.
Standard RadiationRadiation
Also called Radiation Therapy
30.6 Gray (Gy) over 17 fractions concurrent with chemotherapy (institutional standard).
ChemotherapyDrug
Also called Xeloda, Oral capecitabine
3.5 weeks concurrent with radiation therapy (institutional standard).
| Study group | Role | What they receive |
|---|---|---|
| MRg-FU | Experimental | Hyperthermia via magnetic resonance-guided focused ultrasound will be administered once per week for three weeks concurrent with standard radiation and chemotherapy. Receives: Device: Magnetic resonance-guided focused ultrasound; Radiation: Standard Radiation; Drug: Chemotherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Acute toxicities
Gastrointestinal and genitourinary toxicities assessed as per Common Toxicity Criteria for Adverse Effects (CTCAE) v4.0 after each MRg-FU treatment and 30, 60 and 90 days post-treatment.
Measured: 3 months
Secondary outcomes (4)
Late toxicities
Gastrointestinal and genitourinary toxicities assessed as per CTCAE v4.0 every 6 months post-treatment for three years.
Measured: 3 years
The efficacy of MRg-FU in reducing pain
Patient reported pain will be assessed through completion of the Brief Pain Inventory (BPI) and reporting of analgesic usage after each MRg-FU treatment, monthly post-treatment for three months and every 6 months post-treatment for 3 years.
Measured: 3 years
Patient quality of life
Patient reported quality of life will be assessed through completion of the European Organization for Research and Treatment of Cancer (EORTC) Functional Assessment of Cancer Therapy - Colorectal (FACT-C) questionnaire after each MRg-FU treatment, monthly post-treatment for three months and every 6 months post treatment for 3 years.
Measured: 3 years
Assessment of radiologic response following treatment.
Assessment of response using the EORTC Response Evaluation Criteria in Solid Tumors (RECIST) criteria.
Measured: 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Aug 2015 (estimated)
- Study startApr 2015
- Primary completionApr 2021
- Study completionApr 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Recurrent 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 N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 6 participants (actual)
Sponsor and investigators
- Lead sponsor
- William Chu, MD, MSc, FRCPC
- Sponsor type
- University, hospital or other
- Collaborators
- Philips Medical Systems
- Responsible party
- Sponsor-investigator, William Chu, MD, MSc, FRCPC, Sunnybrook Health Sciences Centre
- Investigators
- William Chu, MD, FRCPC, Principal investigator, Sunnybrook Health Sciences Centre
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02528175
- Sponsor's protocol ID
- 273-2011
- Other IDs
- 226861
- Status last verified
- Dec 2023
- First submitted
- 9 Jun 2015
- Last updated
- 7 Dec 2023
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Peng J, Partanen A, Pichardo S, Staruch R, Perry K, McGuffin M, Huang Y, Chan KK, Wong S, Czarnota G, Hynynen K, Chu W. Mild hyperthermia with magnetic resonance- guided high intensity focused ultrasound combined with salvage chemoradiation for recurrent rectal cancer. Int J Hyperthermia. 2024;41(1):2365385. doi: 10.1080/02656736.2024.2365385. Epub 2024 Jun 19.
PubMed 38897584
Study at a glance
From the registry record, last updated by the sponsor on 7 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Magnetic Resonance-Guided High Intensity Focused Ultrasound for Recurrent Rectal Cancer - A Pilot Study
- ClinicalTrials.gov ID
- NCT02528175
- Acronym / sponsor ID
- 273-2011
- Conditions
- Recurrent Rectal Cancer
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 6 participants (actual)
- Lead sponsor
- William Chu, MD, MSc, FRCPCUniversity, hospital or other
- Collaborators
- Philips Medical Systems
- Study start
- Apr 2015
- Primary completion
- Apr 2021 (actual)
- Study completion
- Apr 2022 (actual)
- First posted
- 19 Aug 2015 (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 pilot study hypothesizes that hyperthermia delivered via magnetic resonance-guided focused ultrasound (MRg-FU) is technically feasible and can be safely used in combination with concurrent reirradiation and chemotherapy for the treatment of recurrent rectal cancer. Twenty recurrent rectal cancer patients who are not candidates for surgery will be recruited for hyperthermia treatment delivered via MRg-FU concurrent with reirradiation and oral chemotherapy.
Detailed description
Magnetic resonance-guided focused ultrasound (MRg-FU) is a non-invasive, outpatient modality being investigated for the thermal treatment of cancer. In MRg-FU, a specially designed transducer is used to focus a beam of low intensity ultrasound energy into a small volume at a specific target site in the body. MR is used to identify and delineate the tumour, focus the ultrasound beam on the target and provide real-time thermal mapping to ensure accurate heating of the designated target with minimal effect to the adjacent healthy tissue. The focused ultrasound beam produces therapeutic hyperthermia (40-42°C) in the target field causing protein denaturation and cell damage.
Currently, there is no prospective clinical data reported on the use of MRg-FU in the setting of recurrent rectal cancer. Recurrent rectal cancer is a vexing clinical problem. Current retreatment protocols have limited efficacy. The addition of hyperthermia to radiation and chemotherapy may enhance the therapeutic response. With recent advances in technology, the investigators hypothesize that MRg-FU is technically feasible and can be safely used in combination with concurrent reirradiation and chemotherapy for the treatment of recurrent rectal cancer without increased side-effects.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| MRg-FU | Experimental | Device: Magnetic resonance-guided focused ultrasound, Radiation: Standard Radiation, Drug: ChemotherapyHyperthermia via magnetic resonance-guided focused ultrasound will be administered once per week for three weeks concurrent with standard radiation and chemotherapy. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Able to give informed consent
- Weight <140kg
- Biopsy-proven recurrent rectal adenocarcinoma
- Assessed by the treating surgeon, medical oncologist and radiation oncologist, and following a multidisciplinary discussion, determined to have unresectable and/or inoperable disease in the presence or absence of distant metastases
- Assessed by the treating radiation oncologist and medical oncologist determined to be fit for reirradiation and chemotherapy
Key exclusion criteria (11 listed)
- Abdominal or pelvic surgery (excluding biopsy) ≤ 6 weeks prior to study enrolment
- Chemotherapy or other systemic anti-cancer agent ≤ 6 weeks prior to enrolment
- Previous radiotherapy ≤ 6 weeks prior to enrolment
- Recurrent tumour involves small bowel
- Unable to characterize pain
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-guided focused ultrasoundAlso: MRg-FUTargeted warming of the tumor via 3 weekly MR-guided ultrasound procedures. Concurrent with radiation and chemotherapy. | Device | MRg-FU |
| Standard RadiationAlso: Radiation Therapy30.6 Gray (Gy) over 17 fractions concurrent with chemotherapy (institutional standard). | Radiation | MRg-FU |
| ChemotherapyAlso: Xeloda, Oral capecitabine3.5 weeks concurrent with radiation therapy (institutional standard). | Drug | MRg-FU |
Primary outcome
Acute toxicities
Time frame: 3 months
Gastrointestinal and genitourinary toxicities assessed as per Common Toxicity Criteria for Adverse Effects (CTCAE) v4.0 after each MRg-FU treatment and 30, 60 and 90 days post-treatment.
4 secondary outcomes
Late toxicities
Time frame: 3 years
The efficacy of MRg-FU in reducing pain
Time frame: 3 years
Patient quality of life
Time frame: 3 years
Assessment of radiologic response following treatment.
Time frame: 3 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 7 Dec 2023.
- Derived from this study: PubMed 38897584Peng J, Partanen A, Pichardo S, Staruch R, Perry K, McGuffin M, Huang Y, Chan KK, Wong S, Czarnota G, Hynynen K, Chu W. Mild hyperthermia with magnetic resonance- guided high intensity focused ultrasound combined with salvage chemoradiation for recurrent rectal cancer. Int J Hyperthermia. 2024;41(1):2365385. doi: 10.1080/02656736.2024.2365385. Epub 2024 Jun 19.
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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.
William Chu, MD, FRCPC principal investigator
Sunnybrook Health Sciences Centre
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Magnetic resonance-guided focused ultrasound, Standard Radiation and Chemotherapy in people with Recurrent Rectal Cancer, run by William Chu, MD, MSc, FRCPC 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 10 inclusion and 11 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 7 Dec 2023. 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.
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?
Acute toxicities (time frame: 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02528175, which also lists 1 linked publication.
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 7 Dec 2023.