Moffitt Cancer Center: Clinical Trial 18555

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Clinical Trial 18555

Cancer Type: Thoracic
Study Type: Treatment
NCT#: NCT02635009

Phase: Phase II/III
Prinicipal Investigator:

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

Overview

Study Title

A Randomized Phase II/III Trial of Prophylactic Cranial Irradiation with or without Hippocampal Avoidance for Small Cell Lung Cancer

Summary

The purpose of this study is to compare any good and bad effects of avoiding the hippocampus during whole-brain radiation to the usual whole-brain radiation. The first portion of this study will test if avoiding the hippocampus during whole-brain radiation is as effective as the usual treatment (whole-brain radiation) in decreasing the chance of cancer spreading to the brain. The second portion of the study will test if hippocampal avoidance decreases memory and thinking side effects.

Objective

Primary Objectives: 1. Randomized Phase II Component (Non-Inferiority): Determine whether the 12-month intracranial relapse rate following HA-PCI is non-inferior compared to the rate following PCI for patients with SCLC. 2. Phase III Component (Efficacy): Determine whether HA-PCI reduces the likelihood of 6-month deterioration from baseline in HVLT-R delayed recall compared to PCI for patients with SCLC. Secondary Objectives: 1. Compare time to cognitive failure, as measured by a battery of tests (HVLT-R, COWA test, and TMT Parts A and B), after PCI versus HA-PCI in SCLC. 2. Compare time to cognitive failure as separately measured by each test (HVLT-R for Total Recall and Delayed Recognition, COWA test, and TMT Parts A and B), after PCI versus HA-PCI for SCLC. 3. Compare patient-reported cognitive functioning and other quality of life domains (assessed by the EORTC QLQ-C30 and BN20) between PCI versus HA-PCI for patients with SCLC. 4. Compare overall survival after PCI versus HA-PCI for patients with SCLC. 5. Compare 12-month intracranial relapse rate (at completion of phase III) and time to intracranial relapse after PCI versus HA-PCI for patients with SCLC. 6. Evaluate adverse events according to CTCAE criteria. 7. Correlate changes in HRQOL domains with changes in cognitive testing outcomes following PCI versus HA-PCI for patients with SCLC. 8. Assess cost-effectiveness of HA-PCI (MRT) and PCI (3DCRT) using the EQ-5D-5L. Exploratory Objectives: 1. Collect serum and whole blood for future translational research analyses. 2. Evaluate baseline MR imaging biomarkers of white matter injury and hippocampal volumetry as potential predictors of cognitive decline and differential benefit from HAPCI as compared to PCI. 3. Compare levels of hopefulness between PCI versus HA-PCI for patients with SCLC.

Treatments

Therapies

Medications

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; High-grade neuroendocrine carcinoma or combined SCLC and NSCLC is permitted.

must have a gadolinium contrast-enhanced three-dimensional (3D), spoiled gradient (SPGR), magnetization-prepared rapid gradient echo (MP-RAGE), or turbo field echo (TFE) MRI scan and an axial T2/FLAIR sequence. To yield acceptable image quality, the gadolinium contrast-enhanced three-dimensional SPGR, MP-RAGE or TFE axial MRI scan should use the smallest possible axial slice thickness not exceeding 1.5 mm. Sites may contact the Imaging Co-Chairs for further information or assistance if needed. The MRI must be obtained within 56 days of Step 1 registration. Note: The MRI study 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 (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

Participants 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

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

After chemotherapy, participants 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 => Primary English or French speakers are eligible

Additional criteria apply

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 or other architectural distortion of the ventricular system, including placement of external ventricular drain or ventriculoperitoneal shunt

Planned concurrent chemotherapy during PCI; Concurrent atezolizumab permitted

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

Additional Criteria apply

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