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

NCT02528175 | Completed DMC

• 2 other identifiers: 273-2011226861
• Study Type: interventional
• Target: 6
• Locations: 1 country
• Sites: 1

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.

Conditions

Recurrent Rectal Cancer

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• Late toxicities

  3 years

• The efficacy of MRg-FU in reducing pain

  3 years

• Patient quality of life

  3 years

• Assessment of radiologic response following treatment.

  3 years

Study Arms (1)

MRg-FU

EXPERIMENTAL

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; Radiation: Standard Radiation; Drug: Chemotherapy

Interventions

Magnetic resonance-guided focused ultrasound DEVICE

Targeted warming of the tumor via 3 weekly MR-guided ultrasound procedures. Concurrent with radiation and chemotherapy.

Also known as: MRg-FU

MRg-FU

Standard Radiation RADIATION

30.6 Gray (Gy) over 17 fractions concurrent with chemotherapy (institutional standard).

Also known as: Radiation Therapy

MRg-FU

Chemotherapy DRUG

3.5 weeks concurrent with radiation therapy (institutional standard).

Also known as: Xeloda, Oral capecitabine

MRg-FU

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• William Chu, MD, MSc, FRCPC: lead
• Philips Medical Systems: collaborator

Study Sites (1)

Sunnybrook Health Sciences Centre

Toronto, Ontario, M4N 3M5, Canada

Location

Related Publications (1)

• Peng J, Partanen A, Pichardo S, Staruch R, Perry K, McGuffin M, Huang Y, Chan KK, Wong S, Czarnota G, Hynynen K, Chu W. Mild hyperthermia with magnetic resonance- guided high intensity focused ultrasound combined with salvage chemoradiation for recurrent rectal cancer. Int J Hyperthermia. 2024;41(1):2365385. doi: 10.1080/02656736.2024.2365385. Epub 2024 Jun 19.

  PMID: 38897584 DERIVED

MeSH Terms

Conditions

Rectal Neoplasms

Interventions

Radiotherapy; Drug Therapy; Capecitabine

Condition Hierarchy (Ancestors)

Colorectal Neoplasms; Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Intestinal Diseases; Rectal Diseases

Intervention Hierarchy (Ancestors)

Therapeutics; Deoxycytidine; Cytidine; Pyrimidine Nucleosides; Pyrimidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Fluorouracil; Uracil; Pyrimidinones; Deoxyribonucleosides; Nucleosides; Nucleic Acids, Nucleotides, and Nucleosides

Study Officials

• William Chu, MD, FRCPC

  Sunnybrook Health Sciences Centre

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Radiation Oncologist, Clinician Investigator

Study Record Dates

• First Submitted: June 9, 2015
• First Posted: August 19, 2015
• Study Start: April 1, 2015
• Primary Completion: April 1, 2021
• Study Completion: April 1, 2022
• Last Updated: December 7, 2023

Record last verified: 2023-12

Locations

CA (1)