Magnetic Resonance-Guided High Intensity Focused Ultrasound for Recurrent Rectal Cancer
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|ClinicalTrials.gov Identifier: NCT02528175|
Recruitment Status : Recruiting
First Posted : August 19, 2015
Last Update Posted : July 8, 2019
|Condition or disease||Intervention/treatment||Phase|
|Recurrent Rectal Cancer||Device: Magnetic resonance-guided focused ultrasound Radiation: Standard Radiation Drug: Chemotherapy||Not Applicable|
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 Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||20 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Magnetic Resonance-Guided High Intensity Focused Ultrasound for Recurrent Rectal Cancer - A Pilot Study|
|Study Start Date :||April 2015|
|Estimated Primary Completion Date :||April 2020|
|Estimated Study Completion Date :||April 2022|
Hyperthermia via magnetic resonance-guided focused ultrasound will be administered once per week for three weeks concurrent with standard radiation and chemotherapy.
Device: Magnetic resonance-guided focused ultrasound
Targeted warming of the tumor via 3 weekly MR-guided ultrasound procedures. Concurrent with radiation and chemotherapy.
Other Name: MRg-FU
Radiation: Standard Radiation
30.6 Gray (Gy) over 17 fractions concurrent with chemotherapy (institutional standard).
Other Name: Radiation Therapy
3.5 weeks concurrent with radiation therapy (institutional standard).
- 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.
- Late toxicities [ Time Frame: 3 years ]Gastrointestinal and genitourinary toxicities assessed as per CTCAE v4.0 every 6 months post-treatment for three years.
- The efficacy of MRg-FU in reducing pain [ Time Frame: 3 years ]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.
- Patient quality of life [ Time Frame: 3 years ]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.
- Assessment of radiologic response following treatment. [ Time Frame: 3 years ]Assessment of response using the EORTC Response Evaluation Criteria in Solid Tumors (RECIST) criteria.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02528175
|Contact: William Chu, MD, FRCPC||416-480-6100 ext 7086||William.Chu@sunnybrook.ca|
|Sunnybrook Health Sciences Centre||Recruiting|
|Toronto, Ontario, Canada, M4N 3M5|
|Principal Investigator:||William Chu, MD, FRCPC||Sunnybrook Health Sciences Centre|