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Clinical Trial 20720

Cancer Type: Thoracic
Study Type: Treatment
NCT#: NCT04155034

Phase: Phase III
Principal Investigator: Perez, Bradford

Call 813-745-6100
or 1-800-679-0775 Learn More

Overview

Study Title

S1827, MRI Brain Surveillance Alone Versus MRI Surveillance and Prophylactic Cranial Irradiation (PCI): A Randomized Phase III Trial in Small-Cell Lung Cancer (MAVERICK)

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.

Objective

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

Treatments

Therapies

Radiotherapy

Medications

Inclusion Criteria

Participant must have a histologically confirmed diagnosis of small-cell lung cancer (SCLC)

Participant must have an MRI of the brain performed within 28 days prior to registration documenting no evidence of brain metastases or leptomeningeal disease. Participant 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. Participant s 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. Participant s 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 => Participant 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

Participant must have Zubrod performance status of 0-2

Participants who speak and understand English or French must agree to participate in cognitive function testing

Participant must be offered the opportunity to have specimens submitted for banking

Participants 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 Participant 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

Exclusion Criteria

Participant must not have received prior radiotherapy to the brain or whole brain radiotherapy. Participant s 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

Participant must not have a contraindication to MR imaging, such as implanted metal devices or foreign bodies

Participant must not have a contraindication to gadolinium contrast administration during MR imaging, such as allergy or insufficient renal function

Participant must not have other metastatic malignancies requiring current active treatment

Participant 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 > Note that Participant s 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

Participant 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 Participant 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

If you are interested in learning more about clinical trials, our clinical trial navigators can discuss your options and recommend opportunities that may be suitable for you. Call 813-745-6100 or 1-800-679-0775 (toll-free) or submit a clinical trials inquiry form.