Neurocognitive Assessment for Cancer

Phase-Based Estimates
2
Effectiveness
3
Safety
McFarland Clinic PC - Ames, Ames, IA
Cancer+10 More
Neurocognitive Assessment - Other
Eligibility
18+
All Sexes
Eligible conditions
Cancer

Study Summary

This study is evaluating whether stereotactic radiosurgery is better than standard of care whole brain radiation therapy plus memantine for the treatment of small cell lung cancer that has spread to the brain.

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Eligible Conditions

  • Cancer
  • Neoplasms
  • Carcinoma, Small Cell
  • Carcinoma
  • Lung Cancer
  • Small Cell Lung Carcinoma
  • Metastatic Lung Small Cell Carcinoma
  • Lung Neoplasms
  • Stage IVA Lung Cancer AJCC v8
  • Stage IVB Lung Cancer AJCC v8
  • Stage IV Lung Cancer AJCC v8
  • Recurrent Small Cell Lung Carcinoma
  • Metastatic Malignant Neoplasm in the Brain

Treatment Effectiveness

Effectiveness Estimate

2 of 3
This is better than 85% of similar trials

Study Objectives

This trial is evaluating whether Neurocognitive Assessment will improve 1 primary outcome, 7 secondary outcomes, and 4 other outcomes in patients with Cancer. Measurement will happen over the course of 1 year.

1 year
Perceived Difficulties in Cognition
Preservation of Neurocognitive Function
Symptom Burden
Time to Neurocognitive Failure
10 years
Incidence of adverse events
Salvage procedures used to manage recurrent intracranial disease
Time to incidence of distant brain relapses
Time to leptomeningeal dissemination
Time to local brain recurrence (in brain lesions present at trial enrollment and treated with either stereotactic radiosurgery [SRS] or hippocampal-avoidant whole brain radiotherapy [HA-WBRT])
Year 10
Time delay to salvage WBRT or HA-WBRT in patients on the SRS arm
Year 10
Overall Survival
Year 10
Time to Neurologic Death

Trial Safety

Safety Estimate

3 of 3
This is better than 85% of similar trials

Trial Design

2 Treatment Groups

Arm II (HA-WBRT, memantine)
Arm I (SRS)

This trial requires 200 total participants across 2 different treatment groups

This trial involves 2 different treatments. Neurocognitive Assessment is the primary treatment being studied. Participants will all receive the same treatment. There is no placebo group. The treatments being tested are in Phase 3 and have had some early promising results.

Arm I (SRS)Patients undergo SRS over 1 day (in some cases several days).
Arm II (HA-WBRT, memantine)Patients also undergo HA-WBRT QD for 2 weeks in the absence of disease progression or unacceptable toxicity. Patients will also receive memantine PO QD or BID for up to 24 weeks in the absence of disease progression or unacceptable toxicity.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Stereotactic Radiosurgery
2016
Completed Phase 2
~170

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: 10 years
This trial has the following approximate timeline: 3 weeks for initial screening, variable treatment timelines, and roughly 10 years for reporting.

Closest Location

McFarland Clinic PC - Ames - Ames, IA

Eligibility Criteria

This trial is for patients born any sex aged 18 and older. You must have received newly diagnosed for Cancer or one of the other 10 conditions listed above. There are 10 eligibility criteria to participate in this trial as listed below.

Mark “yes” if the following statements are true for you:
Pathologically (histologically or cytologically) proven diagnosis of small cell lung cancer within 5 years of registration. If the original histologic proof of malignancy is greater than 5 years, then pathological (i.e., more recent) confirmation is required (e.g., from a systemic or brain metastasis);
Patients with de novo or recurrent small cell lung cancer are permitted.
Ten or fewer brain metastases =< 3 cm in largest diameter and outside a 5-mm margin around either hippocampus must be visible on contrast-enhanced magnetic resonance imaging (MRI) performed =< 21 days prior to study entry.
Brain metastases can be diagnosed synchronous to the initial diagnosis of small cell lung cancer or metachronous to the initial diagnosis and management of small cell lung cancer.
The total tumor volume must be 30 cm^3 or less. Lesion volume will be approximated by measuring the lesion's three perpendicular diameters on contrast enhanced, T1-weighted MRI and the product of those diameters will be divided by 2 to estimate the lesion volume (e.g. xyz/2). Alternatively, direct volumetric measurements via slice by slice contouring on a treatment planning software package can be used to calculate the total tumor volume.
REQUIRED MRI ELEMENTS
Post gadolinium contrast-enhanced T1-weighted three-dimensional (3D) spoiled gradient (SPGR). Acceptable 3D SPGR sequences include magnetization prepared 3D gradient recalled echo (GRE) rapid gradient echo (MP-RAGE), turbo field echo (TFE) MRI, BRAVO (Brain Volume Imaging) or 3D Fast FE (field echo). The T1-weighted 3D scan should use the smallest possible axial slice thickness, not to exceed 1.5 mm.
Pre-contrast T1 weighted imaging (3D imaging sequence strongly encouraged).
A minimum of one axial T2 FLAIR (preferred) or T2 sequence is required. This can be acquired as a two dimensional (2D) or 3D image. If 2D, the images should be obtained in the axial plane.
ADDITIONAL RECOMMENDATIONS

Patient Q&A Section

Please Note: These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What are the signs of cancer?

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As this is a complex subject as many of the signs and symptoms of cancer may be vague, it is imperative that signs and symptoms be evaluated in order to diagnose cancer.

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Can cancer be cured?

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This model shows that there is an inherent error in the use of the ‘curing of cancer’ metaphor with regard to cancer. Cancer is a disease that is incurable in the sense of being unable to be cured. We propose the following question as a counter model: ‘how can cancer be cured?’ This question is in response to a metaphorized notion that cancer can or ‘can’ be cured. We highlight that ‘curing’ cancer does not represent or imply the absence of the disease for most people; rather, it represents a medical treatment paradigm in which the disease is cured where cure is not the goal.

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What causes cancer?

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What causes cancer is not always known, but researchers are gaining more information. Most cancers can be traced back to mutations of genes or the genes themselves. The process of cell proliferation can also be involved in cancer. Oncogenes are genes that are involved in cell growth and multiplication. Chemotherapeutics are medicines that can alter the expression of cell genes. Immune system related cancers can also develop, as illustrated in non-Hodgkin's lymphoma. The link between cancer and diet is still being explored.

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What are common treatments for cancer?

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Treatment options are varied, dependent on the type of cancer and the status of the patient, and vary according to age. People over the age of 70 or who have poor health should talk to their doctor about treatments, and seek help for side-effects, as well as treatments that complement their current treatment.\n

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How many people get cancer a year in the United States?

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In the US, about 7.1 million will be diagnosed with cancer at least once during the year, and 5.7 million will die from cancer. As an overview of the public’s awareness, the American Cancer Society reported a total of 2,932,632 new cancer diagnoses in 2015, with an estimated 2687 cancer deaths. With a life expectancy at 77 following age 50 in the U.S., about 6,000 people with non-cancer related deaths are expected to die each year. The U.S. death rate from cancer was the 11th highest in 2017, down from 23rd in 2016. However, in the past decade, the death rate has been on the rise.

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What is cancer?

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The way people live with cancer is changing and we all must take responsibility for the consequences of the new way of living with cancer (and all we need to do). Oncology and palliative care are complementary and not rivals but an essential part of health care. Oncology is the main area for intervention because the quality of life is affected and needs for palliative care are growing exponentially because the cancer population is ageing exponentially, and the prognosis for those who get cancer, increases.

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How does neurocognitive assessment work?

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The NCA is a useful and effective diagnostic and prognostic tool in selected patients, and appears to perform similarly to MMSE score. Results from a recent clinical trial suggests that neuropsychological assessment might be able to play a significant role in evaluating people with unknown cognitive status.

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What are the latest developments in neurocognitive assessment for therapeutic use?

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It is concluded that there is a lack of clinically useful neurocognitive indices to characterize the therapeutic drug activity in patients with chronic and degenerative diseases.

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How serious can cancer be?

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This analysis demonstrates that most patients will survive 3 years or more from the time of diagnosis. There is a substantial overlap in the survival curves of the two groups regardless of the staging. Results from a recent paper may be reassuring for newly diagnosed patients and their families and may reassure clinicians of the potential benefits of early diagnosis.

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What is the survival rate for cancer?

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The survival rate for cancer depends on the type of cancer and the tumor grade. The survival rate is lowest for the most invasive cancers and it is highest for sarcoma and brain cancer\n

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What is the average age someone gets cancer?

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While the number is relatively small, the results are useful for determining whether it makes sense to treat children with cancer and for estimating survival rates of children with cancer. Because cancer affects children differently from adults and the most common cancers in children are cancer of the blood or bone marrow and lymphomas, children constitute a group with different prognoses and different disease management options. Children with cancer should be included in research studies designed to develop new diagnostic technologies and treatments. Findings from a recent study underscore the importance of addressing these issues within the field of pediatric oncology [corrected].

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