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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 : June 25, 2018
Sponsor:
Collaborator:
Philips Medical Systems
Information provided by (Responsible Party):
Dr. William Chu, Sunnybrook Health Sciences Centre

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.

Condition or disease Intervention/treatment Phase
Recurrent Rectal Cancer Device: Magnetic resonance-guided focused ultrasound Radiation: Standard Radiation Drug: Chemotherapy Not Applicable

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 Type : Interventional  (Clinical Trial)
Estimated Enrollment : 20 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Ultrasound

Arm Intervention/treatment
Experimental: MRg-FU
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

Drug: Chemotherapy
3.5 weeks concurrent with radiation therapy (institutional standard).
Other Names:
  • Xeloda
  • Oral capecitabine




Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. Late toxicities [ Time Frame: 3 years ]
    Gastrointestinal and genitourinary toxicities assessed as per CTCAE v4.0 every 6 months post-treatment for three years.

  2. 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.

  3. 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.

  4. Assessment of radiologic response following treatment. [ Time Frame: 3 years ]
    Assessment of response using the EORTC Response Evaluation Criteria in Solid Tumors (RECIST) criteria.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02528175


Contacts
Contact: William Chu, MD, FRCPC 416-480-6100 ext 7086 William.Chu@sunnybrook.ca

Locations
Canada, Ontario
Sunnybrook Health Sciences Centre Recruiting
Toronto, Ontario, Canada, M4N 3M5
Sponsors and Collaborators
Dr. William Chu
Philips Medical Systems
Investigators
Principal Investigator: William Chu, MD, FRCPC Sunnybrook Health Sciences Centre

Responsible Party: Dr. William Chu, Radiation Oncologist, Clinician Investigator, Sunnybrook Health Sciences Centre
ClinicalTrials.gov Identifier: NCT02528175     History of Changes
Other Study ID Numbers: 273-2011
226861 ( Other Identifier: Health Canada )
First Posted: August 19, 2015    Key Record Dates
Last Update Posted: June 25, 2018
Last Verified: June 2018

Additional relevant MeSH terms:
Rectal Neoplasms
Colorectal Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Digestive System Diseases
Gastrointestinal Diseases
Intestinal Diseases
Rectal Diseases