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

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