Clinical Trial Details
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[Information provided by: ClinicalTrials.gov, which provides patients, family members, and members of the public easy and free access to information on clinical studies for a wide range of diseases and conditions.]

NCT02635009 : Whole-Brain Radiation Therapy With or Without Hippocampal Avoidance in Treating Patients With Limited Stage or Extensive Stage Small Cell Lung Cancer
PhasePhase 2/Phase 3
AgesMin: 18 Years Max: N/A
Eligibility
Inclusion Criteria:

- PRIOR TO STEP 1 REGISTRATION

- Histologic proof or unequivocal cytologic proof (fine needle aspiration, biopsy or
two positive sputa) of SCLC within 250 days prior to Step 1 registration

- Patients must have a three-dimensional (3D), T1-weighted, spoiled gradient (SPGR),
magnetization-prepared rapid gradient echo (MP-RAGE), or turbo field echo (TFE) MRI
scan without and with gadolinium contrast-enhanced T1-weighted axial, coronal, and
sagittal sequence acquisitions and standard T2-weighted axial and coronal fluid
attenuation inversion recovery (FLAIR) sequence acquisitions within 28 days of Step 1
registration; to yield acceptable image quality, the pre-contrast-enhanced should
have a resolution of 1 x 1 x 1.2 mm and should follow the protocols established by
the Alzheimer's Disease Neuroimaging Initiative (ADNI); performance of this sequence
at a 3 Tesla field strength is recommended; sites may contact the Imaging Co-Chair,
Dr. Tammie Benzinger, for further information or assistance if needed; to yield
acceptable image quality, the gadolinium contrast-enhanced T1-weighted scan should
use the smallest possible axial slice thickness not exceeding 1.5 mm; the associated
coronal and sagittal sequences can be up to 2.5 mm in slice thickness; this imaging
is considered standard of care

- Note: The MRI study as part of response assessment following chemotherapy can be used
for this purpose, but the appropriate sequences must be obtained; this sequence
cannot be obtained prior to chemotherapy and is mandatory irrespective of
randomization to the experimental or control arm of this study

- Patients must sign a study-specific informed consent prior to study entry

- PRIOR TO STEP 2 REGISTRATION

- The following baseline neurocognitive assessments must be completed within 14 days
prior to Step 2 registration: HVLT-R, TMT, and COWA; the neurocognitive assessments
will be uploaded into the National Surgical Adjuvant Breast and Bowel Project,
Radiation Therapy Oncology Group, and Gynecologic Oncology Group (NRG) Oncology RAVE
system for evaluation by Dr. Wefel; once the upload is complete, a notification will
be sent to the site to proceed to Step 2; note: completed baseline neurocognitive
assessments can be uploaded at the time of Step 1 registration

- Patients must have a baseline raw score greater than 2 on the HVLT-R delayed recall

- Prior to chemotherapy or thoracic radiotherapy, patients must be defined as
limited-stage or extensive-stage SCLC after clinical staging evaluation involving the
following:

- History/physical examination;

- Computed tomography (CT) of the chest and abdomen with contrast (does not have
to be done if the patient has had a positron emission tomography (PET)/CT scan
within 8 weeks prior to initiating chemotherapy or thoracic radiotherapy)

- MRI of the brain

- For patients without evidence of extensive-stage SCLC on chest and abdomen CT
and brain MRI, a PET/CT or bone scan is required to confirm limited-stage SCLC

- Patients must be registered on study no earlier than 1 week and no later than 8 weeks
after completing chemotherapy (+/- thoracic radiotherapy)

- After chemotherapy, patients must be restaged using the same diagnostic work-up as
required pre-chemotherapy; repeat PET/CT or bone scan is not required; patients must
have:

- No central nervous system (CNS) metastases

- Radiographic partial or complete response to chemotherapy in at least one
disease site using Response Evaluation Criteria in Solid Tumors (RECIST)
criteria

- No progression in any site

- Zubrod performance status 0-2

- Women of childbearing potential and male participants must practice adequate
contraception

- Women of childbearing potential must have a negative qualitative serum pregnancy test
=< 2 weeks prior to study entry

- Patients who are primary English or French speakers are eligible

Exclusion Criteria:

- Prior radiotherapy to the head or neck (except for T1 glottic cancer), resulting in
overlap of radiation fields

- Radiographic evidence of CNS metastases

- Radiographic evidence of hydrocephalus

- Planned concurrent chemotherapy or anti-tumor agent during PCI

- Concomitant invasive malignancy or invasive malignancy within the past five years
other than non-melanomatous skin cancer; history of in situ carcinoma (e.g. ductal
carcinoma in situ of breast, in situ carcinoma of the cervix, vulva or larynx) is
permitted

- Contraindication to MR imaging, such as implanted metal devices or foreign bodies or
severe claustrophobia

- Severe, active comorbidity, defined as follows:

- Unstable angina and/or congestive heart failure requiring hospitalization within
the last 6 months

- Transmural myocardial infarction within the last 6 months

- Acute bacterial or fungal infection requiring intravenous antibiotics at the
time of registration

- Hepatic insufficiency resulting in clinical jaundice and/or coagulation defects

- Chronic obstructive pulmonary disease exacerbation or other respiratory illness
requiring hospitalization or precluding study therapy at the time of
registration

- Uncontrolled, clinically significant cardiac arrhythmias

- Women of childbearing potential and male participants who are sexually active and not
willing/able to use medically acceptable forms of contraception
LinksPermanent Link to THIS page: https://virtualtrials.com/nct/display1trial.cfm?nct=NCT02635009      |      Link to official Clinicaltrials.gov listing
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