Purpose

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.

Conditions

Eligibility

Eligible Ages
Over 18 Years
Eligible Genders
All
Accepts Healthy Volunteers
No

Criteria


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

Study Design

Phase
Phase 3
Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel Assignment
Primary Purpose
Treatment
Masking
None (Open Label)

Arm Groups

ArmDescriptionAssigned Intervention
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.
  • 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 names:
    • PCI
Experimental
Arm II (MRI)
Patients undergo MRI scan at 3, 6, 9, 12, 18, and 24 months.
  • 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

Recruiting Locations

Boston Medical Center
Boston, Massachusetts 02118
Contact:
Site Public Contact
617-638-8265

More Details

Status
Recruiting
Sponsor
Southwest Oncology Group

Study Contact

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.

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.