Local Ablative Strategies After Endovascular Radioembolization

NCT02611661 | Terminated Phase 1 DMC FDA Device

• 1 other identifier: 201511087
• Study Type: interventional
• Target: 9
• Locations: 1 country
• Sites: 1

Brief Summary

The rationale for this design is initial utilization of a standard-of-care therapy for mCRC (radioembolization) with a dose-calculation algorithm that has been verified as predictive for treatment response. Prediction of treatment failure will enable the proposed subsequent locoregional therapies which were selected based on safety profiles and feasibility. While the goal of this study is assessing feasibility and safety of this approach, the end goal of improving overall patient outcomes by improved hepatic tumor control.

Conditions

Metastatic Colorectal Cancer

Outcome Measures

Primary Outcomes (1)

• Safety and tolerability of administering hepatic locoregional therapy following radioembolization as measured by occurrences of grade 3 or higher toxicities of interest

  * Strata 2, 3, and 4 only * The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for all toxicity reporting.

  30 days after completion of therapy (approximately 6 weeks)

Secondary Outcomes (4)

• Late toxicity associated with radioembolization followed by dosimetry-guided subsequent hepatic locoregional therapy

  Up to 6 months

• Local recurrence rates associated with radioembolization followed by dosimetry-guided subsequent hepatic locoregional therapy

  Up to 2 years

• Overall survival rates associated with radioembolization followed by dosimetry-guided subsequent hepatic locoregional therapy

  Up to 2 years

• Response rates associated with radioembolization followed by dosimetry-guided subsequent hepatic locoregional therapy

  Up to 6 months

Study Arms (5)

Stratum 1: Observe

OTHER

* PET/MRI within 36 hours of standard of care hepatic radioembolization received off study * No further treatment just observation

Device: PET/MRI

Stratum 2: Percutaneous ablation

EXPERIMENTAL

* PET/MRI within 36 hours of standard of care hepatic radioembolization received off study * Percutaneous ablation can be radiofrequency ablation (RFA), microwave ablation (MWA), cryoablation, and irreversible electroporation

Device: PET/MRI; Radiation: Percutaneous ablation

Stratum 3: SBRT

EXPERIMENTAL

* PET/MRI within 36 hours of standard of care hepatic radioembolization received off study * The planned SBRT dose will be 30 Gy in 5 fractions of 6 Gy each. It is recommended that each fraction be separated by a minimum of 12 hours and a maximum of 8 days.

Device: PET/MRI; Radiation: Stereotactic body radiotherapy

Stratum 4: SBRT + Percutaneous Ablation

EXPERIMENTAL

* PET/MRI within 36 hours of standard of care hepatic radioembolization received off study * Percutaneous ablation can be radiofrequency ablation (RFA), microwave ablation (MWA), cryoablation, and irreversible electroporation * The planned SBRT dose will be 30 Gy in 5 fractions of 6 Gy each. It is recommended that each fraction be separated by a minimum of 12 hours and a maximum of 8 days.

Device: PET/MRI; Radiation: Percutaneous ablation; Radiation: Stereotactic body radiotherapy

Stratum 5: Referral for systemic therapy

NO INTERVENTION

* PET/MRI within 36 hours of standard of care hepatic radioembolization received off study * Referred for further systemic therapy and are not candidates for further locoregional therapy on study.

Interventions

PET/MRI DEVICE

Stratum 1: Observe; Stratum 2: Percutaneous ablation; Stratum 3: SBRT; Stratum 4: SBRT + Percutaneous Ablation

Percutaneous ablation RADIATION

Stratum 2: Percutaneous ablation; Stratum 4: SBRT + Percutaneous Ablation

Stereotactic body radiotherapy RADIATION

Also known as: SBRT

Stratum 3: SBRT; Stratum 4: SBRT + Percutaneous Ablation

Eligibility Criteria

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

You may qualify if:

• Diagnosis of colorectal carcinoma with intrahepatic metastases; limited extrahepatic metastasis is allowed as long as the overall metastatic burden is hepatic dominant.
• Local surgical resection is not possible due to tumor or patient factors.
• Prior locoregional therapy is allowed if completed at least 2 weeks prior to enrollment.
• Prior chemotherapy is allowed if stopped/completed at least 2 weeks prior to enrollment.
• At least 18 years old.
• ECOG performance status ≤ 1.
• Scheduled to undergo radioembolization for treatment of intrahepatic metastases.
• Able to understand and willing to sign an IRB-approved written informed consent document.

You may not qualify if:

• Child-Pugh score 8 or greater.
• ALT or AST ≥ 6 x ULN.
• Prior history of abdominal irradiation. Patients who have received prior pelvic radiation for colorectal cancer are eligible; however, prior radiation treatment plans must be reviewed prior to enrollment.
• Presence of any contraindications to MRI scanning.
• GFR \< 30 ml/min/1.73m2 (if receiving contrast for MRI).
• Currently on dialysis (if receiving contrast for MRI).
• Prior allergic reaction to gadolinium-based contrast agents (if receiving contrast for MRI).
• Pregnant or nursing. Women of childbearing potential must have a negative pregnancy test within 14 days of study entry.
• Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements.

Sponsors & Collaborators

• Washington University School of Medicine: lead

Study Sites (1)

Washington University School of Medicine

St Louis, Missouri, 63110, United States

Location

Related Links

• Alvin J. Siteman Cancer Center at Barnes-Jewish Hospital and Washington University School of Medicine

MeSH Terms

Conditions

Colorectal Neoplasms

Interventions

Catheter Ablation; Radiosurgery

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Radiofrequency Ablation; Radiofrequency Therapy; Therapeutics; Ablation Techniques; Surgical Procedures, Operative; Radiotherapy; Stereotaxic Techniques; Neurosurgical Procedures; Investigative Techniques

Study Officials

• Parag Parikh, M.D.

  Washington University School of Medicine

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 18, 2015
• First Posted: November 23, 2015
• Study Start: January 19, 2016
• Primary Completion: February 13, 2018
• Study Completion: February 13, 2018
• Last Updated: August 16, 2018

Record last verified: 2018-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)