🇮🇪Ireland
16°C Partly Cloudy · Dublin
Live Updates
--:--:-- IST
Contributor sign in
Latest
Astellas Expands Its 330 Million Euro Tralee Biopharma Facility with a Second Aseptic Filling Line to Double Drug-Product Capacity ◆ Xeolas Pharmaceuticals Opens 158,000 Sq Ft State-of-the-Art Baldoyle Facility to Scale Specialty Medicine Manufacturing ◆ Priya Life Science Partners with Fleming for the 9th Annual Corporate Compliance & Transparency in Life Sciences Summit in Zurich ◆ Ireland Has the Capital and the Lessons: Digital Project Management Is How They Become Delivery ◆ Dunbar Pharma Brings First Plant-Derived Dronabinol API to UK Market Through IPS Pharma ◆ Leveraging Priya Life Science as a Data Tracker: The Ultimate Use Case & Career Guide ◆ The €100K Reality Check: Why a Six-Figure Pharma Salary in Ireland Feels Different Than in Switzerland or Germany ◆ Ireland's €93.8 Billion Non-EU Pharma Export Engine: Trade Data, Destination Markets, and Economic Impact ◆ Astellas Expands Its 330 Million Euro Tralee Biopharma Facility with a Second Aseptic Filling Line to Double Drug-Product Capacity ◆ Xeolas Pharmaceuticals Opens 158,000 Sq Ft State-of-the-Art Baldoyle Facility to Scale Specialty Medicine Manufacturing ◆ Priya Life Science Partners with Fleming for the 9th Annual Corporate Compliance & Transparency in Life Sciences Summit in Zurich ◆ Ireland Has the Capital and the Lessons: Digital Project Management Is How They Become Delivery ◆ Dunbar Pharma Brings First Plant-Derived Dronabinol API to UK Market Through IPS Pharma ◆ Leveraging Priya Life Science as a Data Tracker: The Ultimate Use Case & Career Guide ◆ The €100K Reality Check: Why a Six-Figure Pharma Salary in Ireland Feels Different Than in Switzerland or Germany ◆ Ireland's €93.8 Billion Non-EU Pharma Export Engine: Trade Data, Destination Markets, and Economic Impact ◆
Clinical Trials in Mexico / NCT04155034
Active, not recruiting Phase 3

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

NCT04155034 · tracked via the Priya Life Science Mexico tracker
Phase
Phase 3
Started
2020-05-04
Last updated
2026-06-11

Condition(s) studied

Extensive Stage Lung Small Cell CarcinomaLimited Stage Lung Small Cell CarcinomaLung Small Cell Carcinoma

Investigational drug(s) / intervention(s)

Magnetic Resonance ImagingProphylactic Cranial Irradiation

Magnetic Resonance Imaging: Undergo MRI

Prophylactic Cranial Irradiation: Undergo PCI

Study 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.

Eligibility

Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
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

Primary outcome measure(s)

Trial sites (446)

FacilityCityRegionStatus
University of Alabama at Birmingham Cancer Center Birmingham Alabama
Katmai Oncology Group Anchorage Alaska
Fairbanks Memorial Hospital Fairbanks Alaska
University of Arizona Cancer Center-Orange Grove Campus Tucson Arizona
University of Arizona Cancer Center-North Campus Tucson Arizona
City of Hope Corona Corona California
City of Hope Comprehensive Cancer Center Duarte California
Veterans Affairs Loma Linda Healthcare System Loma Linda California
Tibor Rubin VA Medical Center Long Beach California
Los Angeles General Medical Center Los Angeles California
USC / Norris Comprehensive Cancer Center Los Angeles California
University of California Davis Comprehensive Cancer Center Sacramento California
Veterans Affairs Medical Center - San Francisco San Francisco California
City of Hope South Pasadena South Pasadena California
Rocky Mountain Regional VA Medical Center Aurora Colorado
UCHealth University of Colorado Hospital Aurora Colorado
UCHealth Memorial Hospital Central Colorado Springs Colorado
Memorial Hospital North Colorado Springs Colorado
Poudre Valley Hospital Fort Collins Colorado
Cancer Care and Hematology-Fort Collins Fort Collins Colorado
Banner North Colorado Medical Center Greeley Colorado
UCHealth Greeley Hospital Greeley Colorado
UCHealth Highlands Ranch Hospital Highlands Ranch Colorado
Saint Anthony Hospital Lakewood Colorado
Medical Center of the Rockies Loveland Colorado
Banner McKee Medical Center Loveland Colorado
Smilow Cancer Hospital Care Center at Greenwich Greenwich Connecticut
Smilow Cancer Hospital Care Center - Guilford Guilford Connecticut
Smilow Cancer Hospital-Hamden Care Center Hamden Connecticut
Yale University New Haven Connecticut
Smilow Cancer Hospital Care Center-Trumbull Trumbull Connecticut
Smilow Cancer Hospital Care Center - Waterford Waterford Connecticut
Veterans Affairs Connecticut Healthcare System-West Haven Campus West Haven Connecticut
Beebe South Coastal Health Campus Millville Delaware
Helen F Graham Cancer Center Newark Delaware
Medical Oncology Hematology Consultants PA Newark Delaware
Christiana Care Health System-Christiana Hospital Newark Delaware
Beebe Health Campus Rehoboth Beach Delaware
John Fitzgerald Kennedy Medical Center Atlantis Florida
Boca Raton Regional Hospital Boca Raton Florida

+ 406 more sites — see the full list on the official registry below.

More SWOG Cancer Research Network trials in Mexico

Other trials for the same condition

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT04155034 on ClinicalTrials.gov ↗ ← All trials in Mexico