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

Primary Purpose

Recurrent Rectal Cancer

Status
Unknown status
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
Magnetic resonance-guided focused ultrasound
Standard Radiation
Chemotherapy
Sponsored by
Dr. William Chu
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Recurrent Rectal Cancer

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Sunnybrook Health Sciences Centre

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

MRg-FU

Arm Description

Hyperthermia via magnetic resonance-guided focused ultrasound will be administered once per week for three weeks concurrent with standard radiation and chemotherapy.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Late toxicities
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
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
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.
Assessment of response using the EORTC Response Evaluation Criteria in Solid Tumors (RECIST) criteria.

Full Information

First Posted
June 9, 2015
Last Updated
December 15, 2020
Sponsor
Dr. William Chu
Collaborators
Philips Medical Systems
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1. Study Identification

Unique Protocol Identification Number
NCT02528175
Brief Title
Magnetic Resonance-Guided High Intensity Focused Ultrasound for Recurrent Rectal Cancer
Official Title
Magnetic Resonance-Guided High Intensity Focused Ultrasound for Recurrent Rectal Cancer - A Pilot Study
Study Type
Interventional

2. Study Status

Record Verification Date
October 2020
Overall Recruitment Status
Unknown status
Study Start Date
April 2015 (undefined)
Primary Completion Date
April 2021 (Anticipated)
Study Completion Date
April 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Dr. William Chu
Collaborators
Philips Medical Systems

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Recurrent Rectal Cancer

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
6 (Actual)

8. Arms, Groups, and Interventions

Arm Title
MRg-FU
Arm Type
Experimental
Arm Description
Hyperthermia via magnetic resonance-guided focused ultrasound will be administered once per week for three weeks concurrent with standard radiation and chemotherapy.
Intervention Type
Device
Intervention Name(s)
Magnetic resonance-guided focused ultrasound
Other Intervention Name(s)
MRg-FU
Intervention Description
Targeted warming of the tumor via 3 weekly MR-guided ultrasound procedures. Concurrent with radiation and chemotherapy.
Intervention Type
Radiation
Intervention Name(s)
Standard Radiation
Other Intervention Name(s)
Radiation Therapy
Intervention Description
30.6 Gray (Gy) over 17 fractions concurrent with chemotherapy (institutional standard).
Intervention Type
Drug
Intervention Name(s)
Chemotherapy
Other Intervention Name(s)
Xeloda, Oral capecitabine
Intervention Description
3.5 weeks concurrent with radiation therapy (institutional standard).
Primary Outcome Measure Information:
Title
Acute toxicities
Description
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.
Time Frame
3 months
Secondary Outcome Measure Information:
Title
Late toxicities
Description
Gastrointestinal and genitourinary toxicities assessed as per CTCAE v4.0 every 6 months post-treatment for three years.
Time Frame
3 years
Title
The efficacy of MRg-FU in reducing pain
Description
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.
Time Frame
3 years
Title
Patient quality of life
Description
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.
Time Frame
3 years
Title
Assessment of radiologic response following treatment.
Description
Assessment of response using the EORTC Response Evaluation Criteria in Solid Tumors (RECIST) criteria.
Time Frame
3 years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
William Chu, MD, FRCPC
Organizational Affiliation
Sunnybrook Health Sciences Centre
Official's Role
Principal Investigator
Facility Information:
Facility Name
Sunnybrook Health Sciences Centre
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M4N 3M5
Country
Canada

12. IPD Sharing Statement

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

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