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

Recurrent Rectal Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02528175
• Other study ID #: 273-2011
• Secondary ID: 226861
• Status: Completed
• Phase: N/A
• Start date: April 2015
• Est. completion date: April 2022

Study information

• Verified date: December 2023
• Source: Sunnybrook Health Sciences Centre
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 6
• Est. completion date: April 2022
• Est. primary completion date: April 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Rectal Neoplasms
• Recurrence
• Recurrent Rectal Cancer

Intervention

Device:
• Magnetic resonance-guided focused ultrasound
Targeted warming of the tumor via 3 weekly MR-guided ultrasound procedures. Concurrent with radiation and chemotherapy.

Radiation:
• Standard Radiation
30.6 Gray (Gy) over 17 fractions concurrent with chemotherapy (institutional standard).

Drug:
• Chemotherapy
3.5 weeks concurrent with radiation therapy (institutional standard).

Locations

Country	Name	City	State
Canada	Sunnybrook Health Sciences Centre	Toronto	Ontario

Sponsors (2)

Lead Sponsor	Collaborator
William Chu, MD, MSc, FRCPC	Philips Medical Systems

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	3 months
Secondary	Late toxicities	Gastrointestinal and genitourinary toxicities assessed as per CTCAE v4.0 every 6 months post-treatment for three years.	3 years
Secondary	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.	3 years
Secondary	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.	3 years
Secondary	Assessment of radiologic response following treatment.	Assessment of response using the EORTC Response Evaluation Criteria in Solid Tumors (RECIST) criteria.	3 years