A Study of Whole-Brain Radiation Therapy with or without Avoiding the Hippocampus while Treating Patients with Limited or Extensive Stage Small Cell Lung Cancer

Overview

  • Study type

    Interventional
  • Study phase

    II/III
  • Study IDs

  • Describes the nature of a clinical study. Types include:

    • Observational study — observes people and measures outcomes without affecting results.
    • Interventional study (clinical trial) — studies new tests, treatments, drugs, surgical procedures or devices.
    • Medical records research — uses historical information collected from medical records of large groups of people to study how diseases progress and which treatments and surgeries work best.
  • During the early phases (phases 1 and 2), researchers assess safety, side effects, optimal dosages and risks/benefits. In the later phase (phase 3), researchers study whether the treatment works better than the current standard therapy. They also compare the safety of the new treatment with that of current treatments. Phase 3 trials include large numbers of people to make sure that the result is valid. There are also less common very early (phase 0) and later (phase 4) phases. Phase 0 trials are small trials that help researchers decide if a new agent should be tested in a phase 1 trial. Phase 4 trials look at long-term safety and effectiveness, after a new treatment has been approved and is on the market.

  • Site IRB
    • Rochester, Minnesota: 16-003600
    • Eau Claire, Wisconsin: 16-003600
    • Mankato, Minnesota: 16-003600
    • La Crosse, Wisconsin: 16-003600
    • Albert Lea, Minnesota: 16-003600
    NCT ID: NCT02635009
    Sponsor Protocol Number: NRG-CC003

About this study

This randomized phase II/III trial studies how well whole-brain radiation therapy works and compares it with or without hippocampal avoidance in treating patients with small cell lung cancer that is found in one lung, the tissues between the lungs, and nearby lymph nodes only (limited stage) or has spread outside of the lung in which it began or to other parts of the body (extensive stage). Radiation therapy uses high energy x-rays to kill tumor cells and shrink tumors. The hippocampus is part of the brain that is important for memory. Avoiding the hippocampus during whole-brain radiation could decrease the chance of side effects on memory and thinking. It is not yet known whether giving whole-brain radiation therapy is more effective with or without hippocampal avoidance in treating patients with small cell lung cancer.

Participation eligibility

Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. If you need assistance understanding the eligibility criteria, please contact the study team.

See eligibility criteria

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
    • Must have a three-dimensional (3D), T1-weighted, spoiled gradient, magnetization-prepared rapid gradient echo, or turbo field echo MRI scan with and without gadolinium contrast-enhanced T1-weighted axial, coronal, and sagittal sequence acquisitions and standard T2-weighted axial and coronal fluid attenuation inversion recovery sequence acquisitions within 28 days of step 1 registration
      • To yield acceptable image quality, the pre-contrast-enhanced image 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
      • 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
    • 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
    • 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 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 
      • Completed baseline neurocognitive assessments can be uploaded at the time of step 1 registration
    • Must have a baseline raw score greater than 2 on the HVLT-R delayed recall
    • Prior to chemotherapy or thoracic radiotherapy, 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 no 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
    • Must be registered on study no earlier than 1 week and no later than 8 weeks after completing chemotherapy (+/- thoracic radiotherapy)
    • After chemotherapy, must be restaged using the same diagnostic work-up as required pre-chemotherapy
    • Repeat PET/CT or bone scan is not required
    • 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
    • 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, 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

Participating Mayo Clinic locations

Study statuses change often. Please contact us for help.

Mayo Clinic Location Status Contact

Rochester, Minn.

Mayo Clinic principal investigator

Yolanda Garces, M.D.

Open for enrollment

Contact information:

Cancer Center Clinical Trials Referral Office

855-776-0015

Eau Claire, Wis.

Mayo Clinic principal investigator

Yolanda Garces, M.D.

Open for enrollment

Contact information:

Cancer Center Clinical Trials Referral Office

855-776-0015

Mankato, Minn.

Mayo Clinic principal investigator

Yolanda Garces, M.D.

Open for enrollment

Contact information:

Matthew Hoplin C.C.R.C., CCRP

(507)538-3525

Hoplin.Matthew@mayo.edu

La Crosse, Wis.

Mayo Clinic principal investigator

Yolanda Garces, M.D.

Open for enrollment

Contact information:

Cancer Center Clinical Trials Referral Office

855-776-0015

Albert Lea, Minn.

Mayo Clinic principal investigator

Yolanda Garces, M.D.

Open for enrollment

Contact information:

Matthew Hoplin C.C.R.C., CCRP

(507)538-3525

Hoplin.Matthew@mayo.edu

More information

Publications

Publications are currently not available

Study Results Summary

Not yet available

Supplemental Study Information

Not yet available

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CLS-20366127

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