Clinical Trials Logo

Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02683200
Other study ID # 15-000362
Secondary ID NCI-2015-01665
Status Completed
Phase Early Phase 1
First received
Last updated
Start date June 3, 2015
Est. completion date January 1, 2022

Study information

Verified date March 2022
Source Jonsson Comprehensive Cancer Center
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

This pilot clinical trial studies magnetic resonance imaging (MRI)-guided stereotactic body radiation therapy (SBRT) in treating patients with liver metastases or liver cancer. SBRT is a specialized radiation therapy that delivers a single, high dose of radiation directly to the tumor and may kill more tumor cells and cause less damage to normal tissue. Combining MRI with SBRT may help doctors to highlight the tissues surrounding the tumor better.


Description:

PRIMARY OBJECTIVES: I. To assess the feasibility of utilizing an MRI-guided tri-60Co teletherapy system for liver SBRT, as determined the treating radiation oncologist's ability to accurately visualize and align to the target lesion(s). II. To assess the feasibility of using a three versus five fraction scheme, for one versus multiple (i.e., =< 5) target lesions. SECONDARY OBJECTIVES: I. To determine the tumor local control (LC), disease specific survival (DSS), and overall survival (OS). II. To gather biomarkers that may elucidate differential immunogenic responses from the three versus the five fraction SBRT regimens. OUTLINE: Patients undergo MRI-guided Tri-60Co teletherapy SBRT 3-5 fractions over 1-2 weeks. After completion of study treatment, patients are followed up at approximately 4-6 weeks, and then every 3 months for 2 years.


Recruitment information / eligibility

Status Completed
Enrollment 21
Est. completion date January 1, 2022
Est. primary completion date January 1, 2022
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: - Patients may have either metastatic lesions from another primary site or primary hepatocellular carcinoma; patients with one histologically confirmed metastatic lesion of the liver who are presenting for local therapy for lesions concerning for metastases that cannot or should not be biopsied will also be considered for enrollment on a case by case basis; patients can simultaneously receive treatment for multiple hepatic lesions meeting the prior two requirements, at the discretion of the treating radiation oncologist - Karnofsky performance status (KPS) >= 70 - No active infections requiring systemic antibiotics - If a woman is of childbearing potential, a negative urine or serum pregnancy test must be documented; women of childbearing potential must agree to use adequate contraception (hormonal or barrier method of birth control; or abstinence) for duration of study participation and for up to 4 weeks following the study - Ability to understand and willingness to sign a written informed consent Exclusion Criteria: - Pregnant women, or women of childbearing potential who are sexually active and not willing/able to use medically acceptable forms of contraception for the entire study period and for up to 4 weeks after the study - Refusal to sign the informed consent - Patients who are participating in a concurrent treatment protocol - Patients for whom a plan meeting institutional quality criteria cannot be designed for SBRT treatment via the MRI-guided teletherapy unit, but for whom an SBRT plan meeting institutional quality criteria can be designed for a conventional linear accelerator

Study Design


Related Conditions & MeSH terms


Intervention

Radiation:
Image-Guided Adaptive Radiation Therapy
Undergo MRI-guided Tri-60Co teletherapy SBRT
Stereotactic Body Radiation Therapy
Undergo MRI-guided Tri-60Co teletherapy SBRT

Locations

Country Name City State
United States UCLA / Jonsson Comprehensive Cancer Center Los Angeles California

Sponsors (2)

Lead Sponsor Collaborator
Jonsson Comprehensive Cancer Center Eli Lilly and Company

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Plan quality of the MRI guided radiotherapy vs. conventional linac radiotherapy. Comparing the plan quality of the MRI guided radiotherapy to conventional determined by the ability to create treatment plans that are comparable to those generated by a conventional linear accelerator, and by the treating radiation oncologist's ability to accurately visualize and align to the target lesion Up to 2 years
Primary Feasibility of SBRT delivery by the MRI-guided tri-60Co teletherapy system, calculated by recording the number of patients for whom plans were or were not comparable between the two modalities Up to 2 years
Primary Magnitude of target motion in three dimensional space as captured by real time imaging acquired by the MRI guided tri-60 Co teletherapy system Up to 2 years
Primary Velocity of target motion in three dimensional space as captured by real time imaging acquired by the MRI guided tri-60 Co teletherapy system Up to 2 years
Primary Quality of real-time image guidance provided the tri-60Co system, as defined by the treating radiation oncologist's ability to visualize the target lesion using the on-board MRI Up to 2 tears
Secondary Collection of biomarkers that may be associated with an immunologic systemic response to SBRT Up to 2 years
Secondary DSS Up to 2 years
Secondary Frequency of acute grade 2-5 gastrointestinal toxicity graded using the Common Toxicity Criteria version 4.0 Up to 2 years
Secondary Infield tumor LC Up to 2 years
Secondary OS Up to 2 years
Secondary Validity of automatically segmented contours generated by the MRI-guided tri-60Co teletherapy system through independent evaluation of images obtained Up to 2 years
See also
  Status Clinical Trial Phase
Active, not recruiting NCT03068624 - Autologous CD8+ SLC45A2-Specific T Lymphocytes With Cyclophosphamide, Aldesleukin, and Ipilimumab in Treating Patients With Metastatic Uveal Melanoma Phase 1
Recruiting NCT04728633 - Transarterial Chemoembolization for the Treatment of Uveal Melanoma With Liver Metastases Phase 2
Recruiting NCT05863195 - Testing Pump Chemotherapy in Addition to Standard of Care Chemotherapy Versus Standard of Care Chemotherapy Alone for Patients With Unresectable Colorectal Liver Metastases: The PUMP Trial Phase 3
Active, not recruiting NCT02156739 - Contrast-enhanced MRI in Detecting Benign and Malignant Liver Lesions N/A
Recruiting NCT05039632 - Phase I/II Randomized Study of NBTXR3 Activated by Abscopal or RadScopal Radiation in Combination With Immunotherapy (Anti-PD-1/L-1) for Patients With Advanced Solid Malignancies Phase 1/Phase 2
Recruiting NCT05040360 - Testing the Use of Chemotherapy After Surgery for High-Risk Pancreatic Neuroendocrine Tumors Phase 2
Active, not recruiting NCT02738606 - Liver Surgery and Chemotherapy in Treating Patients With Colorectal Cancer With Liver Metastases That Can Be Removed by Surgery and Lung Metastases That Cannot Be Removed by Surgery Phase 2
Active, not recruiting NCT03472586 - Ipilimumab and Nivolumab With Immunoembolization in Treating Participants With Metastatic Uveal Melanoma in the Liver Phase 2
Recruiting NCT05791448 - AU409 for the Treatment of Advanced Primary Liver Cancers or Solid Tumor With Liver Metastatic Disease Phase 1
Completed NCT00862680 - 4D PET/CT in Diagnosing Participants With Lung and Colorectal Cancer With Liver and Lung Metastasis
Active, not recruiting NCT02070549 - Trametinib in Treating Patients With Advanced Cancer With or Without Hepatic Dysfunction Phase 1
Recruiting NCT03203525 - Combination Chemotherapy and Bevacizumab With the NovoTTF-100L(P) System in Treating Participants With Advanced, Recurrent, or Refractory Hepatic Metastatic Cancer Phase 1
Recruiting NCT03844750 - Preoperative Immunotherapy (Pembrolizumab) for Patients With Colorectal Cancer and Resectable Hepatic Metastases Phase 2
Recruiting NCT06449937 - Local Liver Treatment for Multi-organ Colorectal Cancer Metastases N/A
Recruiting NCT04982653 - Short Stitch Versus Traditional Suture for the Prevention of Incisional Hernia After Open Hepatectomy Phase 2
Active, not recruiting NCT02626312 - Radiation Therapy in Treating Patients With Hepatocellular Carcinoma, Cholangiocarcinoma, or Liver Metastasis Who Have Impaired Liver Function Phase 1
Active, not recruiting NCT02364557 - Testing Whether Treating Breast Cancer Metastases With Surgery or High-Dose Radiation Improves Survival Phase 2/Phase 3
Active, not recruiting NCT03457948 - Pembrolizumab With Liver-Directed or Peptide Receptor Radionuclide Therapy for Neuroendocrine Tumors and Liver Metastases Phase 2
Recruiting NCT04796818 - An Investigational Scan (Intravoxel Incoherent Motion Diffusion Weighted Imaging) for the Evaluation of Colorectal Cancer Liver Metastases Treatment Response N/A
Recruiting NCT06016855 - Surgical Debulking Prior to Peptide Receptor Radionuclide Therapy in Well Differentiated Gastroenteropancreatic Neuroendocrine Tumors Phase 4