Magnetic Resonance-Guided High Intensity Focused Ultrasound for Recurrent Rectal Cancer

Not Applicable

Completed

• Conditions: Recurrent Rectal Cancer
• Interventions: Device: Magnetic resonance-guided focused ultrasound; Radiation: Standard Radiation; Drug: Chemotherapy

• Registration Number: NCT02528175
• Lead Sponsor: William Chu, MD, MSc, FRCPC

Brief 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. 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 Timeline

• Study Start: 2015-04
• Study First Submitted: 2015-06-09
• Study First Submitted QC: 2015-08-18
• Study First Posted: 2015-08-19
• Primary Completion: 2021-04
• Study Completion: 2022-04
• Status Verified: 2023-12
• Last Update Submitted: 2023-12-05
• Last Update Posted: 2023-12-07

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 6

Inclusion Criteria

• 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
• 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

Exclusion Criteria

• 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
• 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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
MRg-FU	Magnetic resonance-guided focused ultrasound	Hyperthermia via magnetic resonance-guided focused ultrasound will be administered once per week for three weeks concurrent with standard radiation and chemotherapy.
MRg-FU	Standard Radiation	Hyperthermia via magnetic resonance-guided focused ultrasound will be administered once per week for three weeks concurrent with standard radiation and chemotherapy.
MRg-FU	Chemotherapy	Hyperthermia via magnetic resonance-guided focused ultrasound will be administered once per week for three weeks concurrent with standard radiation and chemotherapy.

Primary Outcome Measures

Name	Time	Method
Acute toxicities	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.

Secondary Outcome Measures

Name	Time	Method
Patient quality of life	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.
Late toxicities	3 years	Gastrointestinal and genitourinary toxicities assessed as per CTCAE v4.0 every 6 months post-treatment for three years.
Assessment of radiologic response following treatment.	3 years	Assessment of response using the EORTC Response Evaluation Criteria in Solid Tumors (RECIST) criteria.
The efficacy of MRg-FU in reducing pain	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.

Trial Locations

Locations (1)

Sunnybrook Health Sciences Centre; 🇨🇦 Toronto, Ontario, Canada