MRI Adaptive Replanning Using ViewRay

NCT02950792 | Withdrawn DMC FDA Device

• 1 other identifier: 20160397
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief Summary

Current dose escalation regimens with and without chemotherapy have failed to achieve improved local control and overall survival over standard of care therapy to date. Difficulties with dose escalation have been largely due to dose limiting toxicities of surrounding normal organs, in particular to the normal lung parenchyma, and esophagus. Real time, online adaptive planning using magnetic resonance imaging (MRI) could achieve significant volume reduction of primary lung disease over the course of therapy, thereby reducing dose to normal structures, and providing a mechanism in which to dose escalate safely, and more effectively with accurate target delineation. The investigators hypothesize that MRI based adaptive planning will provide a novel method to dose escalate safely with acceptable organ at risk doses. In addition, further improvements in radiotherapy targeting accuracy, normal tissue avoidance, and conformality of target-tissue coverage will be achieved through the use of 4D real-time tracking which is derived by deformably registering daily MR and planning MR (MRsim) and Computed Tomography Simulator (CTsim) with advanced non-rigid image-registration tools.

Conditions

Non-Small Cell Lung Cancer

Keywords

Non-Small Cell Lung Cancer; NSCLC

Outcome Measures

Primary Outcomes (2)

• Rate of Locoregional Failure/Progression (LRF/LRP) in Study Participants Receiving Protocol Therapy.

  MRI-based adaptative radiation planning can provide a method for dose escalation to improve locoregional Failure (LRF/LRP) rates at 2 years in study participants. Locoregional failure/progression (LRF/LRP) will be defined as development of progressive lung cancer centered within 1 cm from the initial planning target volume (PTV). Progressive disease in any of the 14 nodal stations will be considered as regional recurrence. Progression will be assessed by Response Evaluation Criteria In Solid Tumors (RECIST) 1.1 criteria. with integration of MRI/CT.

  Up to 2 Years After Protocol Therapy

• Rate of Severe Treatment-Induced Toxicity

  Rate of severe (grade 3 CTCAE, v.4) radiation-induced lung toxicity (RILT) and other severe adverse events, including grade 3+ (CTCAE, v.4) esophagitis, or grade 2 pericardial effusions, or any grade cardiac adverse events related to chemo-radiation using MRI-based adaptive planning vs. historical controls using conventional plans.

  Up to 2 Years Post-End of Protocol Therapy

Secondary Outcomes (6)

• Rate of Overall Survival (OS) in Study Participants

  Up to 3 years after protocol therapy.

• Rate of Progression-Free Survival (PFS) in Study Participants

  Up to 3 years after protocol therapy.

• Rate of Lung Cancer-Specific Survival

  Up to 3 years after protocol therapy.

• Comparison of Gross Tumor Volumes (GTV) defined by MRI vs. FanBeam CT (FBCT) at CT Simulation and at each adaptive planning time point.

  Daily Up to 5 weeks after start of protocol therapy

• Development of a Database consisting all Daily MR data sets to support further research.

  Up to 5 years

Study Arms (1)

ViewRay MRI-IGART

EXPERIMENTAL

ViewRay MRI-Image-Guided Adaptive Radiation Therapy (IGART): * Daily MRI on ViewRay 5 days per week for 4 weeks in combination with weekly standard of care chemo-radiation. * Daily MRI on ViewRay during Week 5 in combination with Stereotactic Body Radiation Therapy boost for daily for up to 1 week. * Continued standard of care consolidation chemotherapy every 21 days for 3 cycles, beginning 4 - 6 weeks after completion radiation therapy, .

Device: ViewRay MRI; Radiation: Stereotactic Body Radiation Therapy Boost

Interventions

ViewRay MRI DEVICE

ViewRay Magnetic Resonance Imaging

Also known as: ViewRay Magnetic Resonance Imaging

ViewRay MRI-IGART

Stereotactic Body Radiation Therapy Boost RADIATION

In the (week 5), all patients will have a week 5 MRI and Four-dimensional computed tomography (4D CT) for purposes of planning Phase II boost. Gross tumors \< 5 cm will receive a MR-based adaptive replanning Stereo boost of 80 Gy - 90 Gy (20 Gy-30 Gy in 5 fractions). Gross tumors \< 5cm will receive an MR-based adaptive replan fractionated boost to 74 Gy at 2.4 Gy/day. Individualized radiation therapy prescription to primary tumor will maintain organs at risk (OAR) constraints to lung including mean lung dose (MLD) \< 20 Gy with V20 \< 37%. Simultaneously, MRI-based adaptive replanning boost of 12 Gy in 5 fractions (2.4 Gy/day) will be given to gross lymph nodes. Final doses prescribed will be limited by doses to all OARs.

Also known as: Stereotactic radiosurgery (SRS) Boost

ViewRay MRI-IGART

Eligibility Criteria

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

You may qualify if:

• Patient must have primary lung tumor identified on MRI, histologically proven to be NSCLC.
• Patients must be clinical AJCC stage IIIA or IIIB (AJCC 7th ed) with non-operable disease; evaluated by a multidisciplinary treatment team including at least 1 thoracic surgeon within 8 weeks prior to registration.
• Patients with multiple, ipsilateral pulmonary nodules (T3, or T4) are eligible
• Minimum diagnostic workup to include:
• History/physical examination, including documentation of weight, within 8 weeks prior to registration (2 weeks optimal)
• Diagnostic CT scan for staging and RT plan within 4 weeks prior to registration;
• CT scan or sim CT of chest and upper abdomen (IV contrast is recommended unless medically contraindicated) within 6 weeks prior to registration;
• CT scan of the brain (contrast is recommended unless medically contraindicated) or MRI of the brain within 6 weeks prior to registration
• Able to tolerate repeated MRI imaging
• Pulmonary function tests, including diffusing capacity of the lung for carbon monoxide (DLCO), within 6 weeks prior to registration; patients must have forced expiratory volume in one second (FEV1) ≥ 1.2 Liter or ≥ 50% predicted without bronchodilator;
• Zubrod Performance Status 0-1 within 2 weeks prior to registration
• Age ≥ 18;
• Complete blood count (CBC)/differential obtained no more than 8 weeks prior to registration on study, with adequate bone marrow function defined as follows:
• White blood cell (WBC) ≥ 4000/ml
• Absolute neutrophil count (ANC) ≥1,800 cells/mm

You may not qualify if:

• Patients with any component of small cell lung carcinoma are excluded
• Evidence of distant metastases.
• Patients with evidence of a malignant pleural or pericardial effusion.
• Previous systemic chemotherapy (for any cancer) or pelvic radiation therapy
• A prior or concurrent malignancy of any other site or histology unless the patient has been disease free for greater than or equal to five years except for nonmelanoma skin cancer and/or stage T1a prostate cancer or carcinoma in situ of the uterine cervix.
• Prior radiotherapy that would result in overlap of radiation fields
• Patients taking drugs with potential nephrotoxicity or ototoxicity (such as aminoglycosides)
• Prior allergic reaction to the study drug(s) involved in this protocol
• Patients with T4 disease with radiographic evidence of invasion of a large pulmonary artery and tumor causing significant narrowing and destruction of that artery are excluded.
• Severe active co-morbidity:
• Unstable angina and/or congestive heart failure requiring hospitalization within the last 6 months
• Transmural myocardial infarction within the last 6 months
• Acute bacterial or fungal infection requiring intravenous antibiotics at the time of registration
• Chronic Obstructive Pulmonary Disease exacerbation or other respiratory illness requiring hospitalization or precluding study therapy at the time of registration
• Hepatic insufficiency resulting in clinical jaundice and/or coagulation defects (Note: laboratory tests for liver function and coagulation parameters are not required for entry into this protocol)

Sponsors & Collaborators

• University of Miami: lead

Study Sites (1)

University of Miami

Miami, Florida, 33136, United States

Location

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell Lung

Interventions

Radiosurgery; Spermine Synthase

Condition Hierarchy (Ancestors)

Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Radiotherapy; Therapeutics; Stereotaxic Techniques; Neurosurgical Procedures; Surgical Procedures, Operative; Investigative Techniques; Alkyl and Aryl Transferases; Transferases; Enzymes; Enzymes and Coenzymes

Study Officials

• Adrian Ishkanian, MD

  University of Miami

  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: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: October 24, 2016
• First Posted: November 1, 2016
• Study Start: August 1, 2017
• Primary Completion: August 8, 2017
• Study Completion: August 8, 2017
• Last Updated: August 25, 2017

Record last verified: 2017-08

Locations

US (1)