Clinical Trials Logo

Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02528175
Other study ID # 273-2011
Secondary ID 226861
Status Completed
Phase N/A
First received
Last updated
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
Health authority
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

Study Design


Related Conditions & MeSH terms


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
See also
  Status Clinical Trial Phase
Completed NCT01987726 - Comprehensive Gene Sequencing in Guiding Treatment Recommendations Patients With Metastatic or Recurrent Solid Tumors
Active, not recruiting NCT00826540 - Sorafenib and Bevacizumab in Treating Patients With Metastatic Colorectal Cancer Phase 2
Completed NCT00025337 - Combination Chemotherapy With or Without Bevacizumab Compared With Bevacizumab Alone in Treating Patients With Advanced or Metastatic Colorectal Cancer That Has Been Previously Treated Phase 3
Recruiting NCT04642924 - SGM-101 in Locally Advanced and Recurrent Rectal Cancer Phase 2/Phase 3
Completed NCT01846520 - Family Caregiver Palliative Care Intervention in Supporting Caregivers of Patients With Stage II-IV Gastrointestinal, Gynecologic, Urologic and Lung Cancers N/A
Completed NCT01217450 - Selumetinib and Cetuximab in Treating Patients With Refractory Solid Tumors Phase 1
Completed NCT01191684 - Vaccine Therapy in Treating Patients With Colorectal, Stomach, or Pancreatic Cancer Phase 1
Terminated NCT01238965 - Panobinostat and Fluorouracil Followed By Leucovorin Calcium in Treating Patients With Stage IV Colorectal Cancer Who Did Not Respond to Previous Fluorouracil-Based Chemotherapy Phase 1
Terminated NCT01285102 - Chemoembolization Using Irinotecan in Treating Patients With Liver Metastases From Metastatic Colon or Rectal Cancer Phase 1
Terminated NCT01233505 - Veliparib, Oxaliplatin, and Capecitabine in Treating Patients With Advanced Solid Tumors Phase 1
Completed NCT01037790 - Phase II Trial of the Cyclin-Dependent Kinase Inhibitor PD 0332991 in Patients With Cancer Phase 2
Completed NCT00551421 - Pertuzumab and Cetuximab in Treating Patients With Previously Treated Locally Advanced or Metastatic Colorectal Cancer Phase 1/Phase 2
Completed NCT00407654 - VEGF Trap in Treating Patients With Previously Treated Metastatic Colorectal Cancer Phase 2
Completed NCT00091182 - Oxaliplatin in Treating Young Patients With Recurrent Solid Tumors That Have Not Responded to Previous Treatment Phase 2
Terminated NCT00052585 - Gefitinib and Combination Chemotherapy in Treating Patients With Advanced or Recurrent Colorectal Cancer Phase 2
Completed NCT00023933 - Radiolabeled Monoclonal Antibody Therapy in Treating Patients With Recurrent or Persistent Metastatic Colorectal Cancer Phase 1
Not yet recruiting NCT05076305 - PelvEx 4: Advanced Pelvic Malignancy and the Role of the Multi-disciplinary Team Meeting
Completed NCT01740648 - Trametinib, Fluorouracil, and Radiation Therapy Before Surgery in Treating Patients With Stage II-III Rectal Cancer Phase 1
Terminated NCT00397878 - AZD0530 (NSC 735464) in Treating Patients With Previously Treated Metastatic Colon Cancer or Rectal Cancer Phase 2
Completed NCT00100841 - Phase II Trial of FOLFOX6, Bevacizumab and Cetuximab in Patients With Colorectal Cancer Phase 2