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SWOG S1827 (MAVERICK) Testing Whether the Use of Brain Scans Alone Instead of Brain Scans Plus Preventive Brain Radiation Affects Lifespan in Patients With Small Cell Lung Cancer

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ClinicalTrials.gov Identifier: NCT04155034
Recruitment Status : Recruiting
First Posted : November 7, 2019
Last Update Posted : August 12, 2020
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Southwest Oncology Group

Tracking Information
First Submitted Date  ICMJE November 5, 2019
First Posted Date  ICMJE November 7, 2019
Last Update Posted Date August 12, 2020
Actual Study Start Date  ICMJE January 10, 2020
Estimated Primary Completion Date November 15, 2025   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: November 5, 2019)
Overall survival (OS) [ Time Frame: From the date of registration to date of death due to any cause, assessed up to 2 years after randomization ]
Will evaluate OS with magnetic resonance imaging (MRI) surveillance alone and MRI surveillance combined with prophylactic cranial irradiation (PCI) for the treatment of small cell lung cancer (SCLC).
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: November 5, 2019)
  • Cognitive failure-free survival (CFFS) [ Time Frame: Baseline to first neurocognitive failure CF or death due to any cause, assessed up to 12 months after randomization ]
    The comparison of CFFS up to 12 months between the arms will be done using a 1-sided 5% level log-rank test.
  • CFFS rate [ Time Frame: Baseline to first neurocognitive failure CF or death due to any cause, assessed at 90, 180, 270, 360, 540, and 720 days after randomization ]
    There will be a comparison of the CFFS rates between the arms at each of the assessment times and the cumulative incidence of cognitive failure, evaluating death as a competing risk. The CFFS rates at the landmark times will be estimated using the method of Kaplan-Meier and the difference in rates will be evaluated using a 90% confidence interval using Greenwood?s formula.
  • Cumulative incidence of cognitive failure [ Time Frame: Neurocognitive function test will be assessed at 90, 180, 270, 360, 540, and 720 days after randomization ]
    The cumulative incidence of cognitive failure in the presence of the competing risk of death will be estimated used the method of Fine and Gray.
  • OS in an "as-treated" analysis [ Time Frame: From the date of registration to date of death due to any cause, assessed up to 2 years after randomization. Patients will be seen at day 90, 180, 270, 360, 540, and 720 ]
    The comparison of OS in the ?as-treated? analysis will be done as described for the primary analysis, however patients will be categorized per treatment received (patients who do not accept their randomized assignment will be analyzed per treatment received). The number of patients not accepting the randomized assignment will also be summarized.
  • Brain metastases-free survival (BMFS) [ Time Frame: Up to 2 years after randomization. Patients will have MRI on day 90, 180, 270, 360, 540, and 720 ]
    This will be estimated using the method of Kaplan-Meier and comparisons will be done using a log-rank test at the 1-sided 0.05 level. Hazard ratios and associated confidence intervals will be estimated using a Cox Proportional hazards model. Confidence intervals for medians will be estimated using the method of Brookmeyer-Crowley.
  • Incidence of adverse events [ Time Frame: Up to 2 years after randomization. Patients will be assessed for adverse event after PCI (for patients on PCI + MRI arm) and at month 3 (all patients) ]
    Binary proportions and associated confidence intervals will be estimated.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE SWOG S1827 (MAVERICK) Testing Whether the Use of Brain Scans Alone Instead of Brain Scans Plus Preventive Brain Radiation Affects Lifespan in Patients With Small Cell Lung Cancer
Official Title  ICMJE MRI Brain Surveillance Alone Versus MRI Surveillance and Prophylactic Cranial Irradiation (PCI): A Randomized Phase III Trial in Small-Cell Lung Cancer (MAVERICK)
Brief Summary This phase III trial studies magnetic resonance imaging (MRI) surveillance and prophylactic cranial irradiation (PCI) to see how well they work compared to MRI surveillance alone in treating patients with small cell lung cancer. MRI scans are used to monitor the possible spread of the cancer with an MRI machine over time. PCI is radiation therapy that is delivered to the brain in hopes of preventing spread of cancer into the brain. The use of brain MRI alone may reduce side effects of receiving PCI and prolong patients' lifespan. Monitoring with MRI scans alone (delaying radiation until the actual spread of the cancer) may be at least as good as the combination of PCI with MRI scans.
Detailed Description

PRIMARY OBJECTIVE:

I. To evaluate whether overall survival (OS) with magnetic resonance imaging (MRI) surveillance alone is not inferior to MRI surveillance combined with prophylactic cranial irradiation (PCI) for the treatment of small cell lung cancer (SCLC).

SECONDARY OBJECTIVES:

I. To compare cognitive failure free survival (CFFS) rate up to 12 months after randomization between the arms.

II. To compare brain-metastasis-free survival between the arms. III. To compare OS between the arms within the subgroups of patients with limited-stage and extensive-stage disease.

IV. To compare cognitive failure free survival (CFFS) rates at the assessment times between the arms.

V. To compare the cumulative incidence of cognitive failure with death as a competing risk between the arms.

VI. To compare the frequency and severity of toxicities between the two arms.

ADDITIONAL OBJECTIVE:

I. To collect blood for banking.

OUTLINE: Patients are randomized to 1 of 2 arms.

ARM I: Patients undergo conventional or hippocampal avoidance PCI over 20 minutes 5 days per week for 2 weeks. Patients also undergo MRI scan at 3, 6, 9, 12, 18, and 24 months.

ARM II: Patients undergo MRI scan at 3, 6, 9, 12, 18, and 24 months.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • Extensive Stage Lung Small Cell Carcinoma
  • Limited Stage Lung Small Cell Carcinoma
  • Lung Small Cell Carcinoma
Intervention  ICMJE
  • Procedure: Magnetic Resonance Imaging
    Undergo MRI
    Other Names:
    • Magnetic Resonance Imaging Scan
    • Medical Imaging, Magnetic Resonance / Nuclear Magnetic Resonance
    • MR Imaging
    • MRI
    • MRI Scan
    • NMR Imaging
    • NMRI
    • Nuclear Magnetic Resonance Imaging
  • Radiation: Prophylactic Cranial Irradiation
    Undergo PCI
    Other Name: PCI
Study Arms  ICMJE
  • Active Comparator: Arm I (PCI, MRI)
    Patients undergo conventional or hippocampal avoidance PCI over 20 minutes 5 days per week for 2 weeks. Patients also undergo MRI scan at 3, 6, 9, 12, 18, and 24 months.
    Interventions:
    • Procedure: Magnetic Resonance Imaging
    • Radiation: Prophylactic Cranial Irradiation
  • Experimental: Arm II (MRI)
    Patients undergo MRI scan at 3, 6, 9, 12, 18, and 24 months.
    Intervention: Procedure: Magnetic Resonance Imaging
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: November 5, 2019)
668
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE November 15, 2027
Estimated Primary Completion Date November 15, 2025   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Patient must have a histologically confirmed diagnosis of small-cell lung cancer (SCLC)
  • Patient must have an MRI of the brain performed within 28 days prior to registration documenting no evidence of brain metastases or leptomeningeal disease. Patient also must not have a history of brain metastases or leptomeningeal disease
  • Immunotherapy concurrent with and/or adjuvant to first-line therapy is allowed at the discretion of the treating physician. Patients with limited-stage (LS)-SCLC must have completed platinum-based chemotherapy and either definitive thoracic radiotherapy (including stereotactic body radiation therapy [SBRT] for early-stage T1-2 N0 M0 disease who do not undergo surgery) or definitive surgical resection; thoracic radiation in addition to definitive surgical resection is allowed at the discretion of the treating physician, but is not required. Patients with extensive-stage (ES)-SCLC must have completed platinum-based chemotherapy either with or without thoracic radiotherapy at the discretion of the treating physician
  • All adverse events from prior treatment must have resolved to =< grade 2 (Common Terminology Criteria for Adverse Events [CTCAE] version 5.0) prior to randomization
  • Patient must have had a response to first-line therapy and no evidence of progression in opinion of the treating investigator. Systemic imaging (computed tomography [CT] or positron emission tomography [PET]/CT including the chest and abdomen) must be performed within 28 days prior to randomization
  • No more than 8 weeks may have elapsed between day 1 of the last cycle of chemotherapy and randomization
  • Patient must not have received prior radiotherapy to the brain or whole brain radiotherapy. Patients who have undergone prior stereotactic radiosurgery for benign tumors or conditions (e.g., acoustic neuroma, grade I meningioma, trigeminal neuralgia) may be considered on a case-by-case basis
  • Patient must have Zubrod performance status of 0-2
  • Patient must not have a contraindication to MR imaging, such as implanted metal devices or foreign bodies
  • Patient must not have a contraindication to gadolinium contrast administration during MR imaging, such as allergy or insufficient renal function
  • Patient must not have other metastatic malignancies requiring current active treatment
  • Patient must not have any severe active comorbidities, defined as follows:

    • Unstable angina and/or congestive heart failure requiring hospitalization within 6 months prior to randomization
    • Transmural myocardial infarction within 6 months prior to randomization
    • Acute bacterial or fungal infection requiring intravenous antibiotics at the time of randomization
    • Chronic obstructive pulmonary disease exacerbation or other acute respiratory illness precluding study therapy at the time of randomization
    • Severe hepatic disease defined as a diagnosis of Child-Pugh class B or C hepatic disease
    • Human immunodeficiency virus (HIV) positive with CD4 count < 200 cells/microliter

      • Note that patients who are HIV positive are eligible, provided they are under treatment with highly active antiretroviral therapy (HAART) and have a CD4 count >= 200 cells/microliter within 16 weeks prior to randomization
      • Note also that HIV testing is not required for eligibility for this protocol
  • Patient must not be pregnant because of fetal risks from radiation exposure. Men must have agreed to use an effective contraceptive method during PCI and for six months after completing PCI. Women of reproductive potential must have agreed to use an effective contraceptive method during PCI. A woman is considered to be of "reproductive potential" if she has had menses at any time in the preceding 12 consecutive months. In addition to routine contraceptive methods, "effective contraception" also includes heterosexual celibacy and surgery intended to prevent pregnancy (or with a side-effect of pregnancy prevention) defined as a hysterectomy, bilateral oophorectomy or bilateral tubal ligation. However, if at any point a previously celibate patient chooses to become heterosexually active during the time period for use of contraceptive measures outlined in the protocol, he/she is responsible for beginning contraceptive measures
  • Patients who speak and understand English or French must agree to participate in cognitive function testing
  • Patient must be offered the opportunity to have specimens submitted for banking
  • Patients must be informed of the investigational nature of this study and must sign and give written informed consent in accordance with institutional and federal guidelines
  • As a part of the Oncology Patient Enrollment Network (OPEN) randomization process the treating institution?s identity is provided in order to ensure that the current (within 365 days) date of institutional review board approval for this study has been entered in the system
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04155034
Other Study ID Numbers  ICMJE S1827
NCI-2019-05338 ( Registry Identifier: CTRP (Clinical Trial Reporting Program) )
S1827 ( Other Identifier: SWOG )
S1827 ( Other Identifier: CTEP )
U10CA180888 ( U.S. NIH Grant/Contract )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Southwest Oncology Group
Study Sponsor  ICMJE Southwest Oncology Group
Collaborators  ICMJE National Cancer Institute (NCI)
Investigators  ICMJE
Principal Investigator: Chad G Rusthoven Southwest Oncology Group
PRS Account Southwest Oncology Group
Verification Date August 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP