Single Photon Emission Computed Tomography for Stage III Lung Cancer AJCC v8

Phase-Based Estimates
1
Effectiveness
1
Safety
M D Anderson Cancer Center, Houston, TX
+6 More
Single Photon Emission Computed Tomography - Procedure
Eligibility
18+
All Sexes
Eligible conditions
Stage III Lung Cancer AJCC v8

Study Summary

Cardiovascular Injury and Cardiac Fitness in Locally Advanced Non-Small Cell Lung Cancer Patients Receiving Model Based Personalized Chemoradiation

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Eligible Conditions

  • Lung Cancer
  • Carcinoma, Non-Small-Cell Lung
  • Stage III Lung Cancer AJCC v8
  • Lung Neoplasms
  • Stage IIIC Lung Cancer AJCC v8
  • Stage IIIA Lung Cancer AJCC v8
  • Locally Advanced Lung Non-Small Cell Carcinoma
  • Stage IIIB Lung Cancer AJCC v8

Treatment Effectiveness

Study Objectives

This trial is evaluating whether Single Photon Emission Computed Tomography will improve 2 primary outcomes and 4 secondary outcomes in patients with Stage III Lung Cancer AJCC v8. Measurement will happen over the course of Within 12-month of completion of CRT].

Up to 10 years
Overall survival
Month 24
EuroQol 5 Dimension 5 Level: Patient reported outcomes
MD Anderson Symptom Inventory-Lung Cancer: Patient Report outcomes
Overall cardiac fitness
Within 12-month of completion of CRT]
Incidence of grade >= 2 cardiovascular events
up to 24 months
Increase in level of hs-TnT >= 5ng/L

Trial Safety

Trial Design

2 Treatment Groups

No Control Group
Model Based Personalized Treatment Plan (Cohort Two)

This trial requires 100 total participants across 2 different treatment groups

This trial involves 2 different treatments. Single Photon Emission Computed Tomography is the primary treatment being studied. Participants will be divided into 2 treatment groups. There is no placebo group. The treatments being tested are in Phase 1 and are in the first stage of evaluation with people.

Model Based Personalized Treatment Plan (Cohort Two)Patients undergo SPECT/CT with stress test and echocardiogram with strain before RT, 6-8 weeks and 12 months after completion of RT. Patients also participate in 6 MWT before RT, 2-3 and 6-7 weeks during RT, then 6-8 weeks, 4-6 months and 12 months after completion of RT. Patients undergo blood sample collection and complete questionnaires over 3-5 minutes before RT, 2-3, 4-5, 6-7 weeks after the initiation of RT, then at 3, 6, 12, and 24 months after completion of RT.
Standard Treatment Plan (Cohort One)Patients undergo SPECT/CT with stress test and echocardiogram with strain before RT, 6-8 weeks and 12 months after completion of RT. Patients also participate in 6 MWT before RT, 2-3 and 6-7 weeks during RT, then 6-8 weeks, 4-6 months and 12 months after completion of RT. Patients undergo blood sample collection and complete questionnaires over 3-5 minutes before RT, 2-3, 4-5, 6-7 weeks after the initiation of RT, then at 3, 6, 12, and 24 months after completion of RT.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Single Photon Emission Computed Tomography
2008
Completed Phase 4
~260
Biospecimen Collection
2004
Completed Phase 1
~250
Echocardiography
2013
Completed Phase 4
~11830
Computed Tomography
2017
Completed Phase 2
~3460

Trial Logistics

Trial Timeline

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

Closest Location

M D Anderson Cancer Center - Houston, TX

Eligibility Criteria

This trial is for patients born any sex aged 18 and older. There are 7 eligibility criteria to participate in this trial as listed below.

Mark “yes” if the following statements are true for you:
Patient with histologic diagnosis of non-small cell lung cancer
The recommended treatment is thoracic radiation therapy combined with concurrent systemic therapy (chemotherapy and/or immunotherapy) with or without neoadjuvant and/or adjuvant systemic therapy (chemotherapy, immunotherapy, targeted therapy)
>= 18 years of age
Karnofsky performance status (KPS) >= 70
Willing and able to sign informed consents
Able and willing to perform 6minute walking test
Able and willing to preform required cardiac imaging examinations

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 causes stage iii lung cancer ajcc v8?

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The cause of stage iii [lung cancer](https://www.withpower.com/clinical-trials/lung-cancer)s is not well understood. Although cancer is caused in part by environmental exposures, genetic factors have been shown to occur as the first step in cancer genesis. A few well established environmental factors are suggested, but further work is required.

Unverified Answer

What is stage iii lung cancer ajcc v8?

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Stage iii cancer of the lung is a group of cancer that tends to invade the lung tissues but that usually does not spread to other areas. Symptoms can include cough, dyspnea (shortness of breath) on exertion, chest pain and/or weight loss as the disease worsens. Patients with this type of lung (or in rare cases, other types of cancers) will often have stage iii lung cancer detected earlier in time by their signs and symptoms. Early detection through screening lowers the probability of having a late-stage (iv or v stages) cancer.

Unverified Answer

What are the signs of stage iii lung cancer ajcc v8?

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stage iii is the most prevalent stage of [lung cancer](https://www.withpower.com/clinical-trials/lung-cancer) in our study group with a maximum depth of tumor in stage iii of 14 cm or greater. In a review of the published series, the median survival for stage iii cancer is only 12 months with the 5-year survival rate of 29%. Stage iii can be diagnosed only after surgery once a pathologically proven diagnosis of lung cancer by an experienced pathologist is obtained.

Unverified Answer

How many people get stage iii lung cancer ajcc v8 a year in the United States?

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Stage iii lung cancer is rare in the United States. It is more prevalent in certain population groups. Most notably, non-Hispanic blacks and Hispanic women have increased rates. Stage iii lung cancer should remain as one of the top categories in staging and reporting of lung cancer.

Unverified Answer

What are common treatments for stage iii lung cancer ajcc v8?

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There are many different management options for stage iii cancer but the most common treatment for staging iii lung cancer includes adjuvant chemotherapy and postoperative radiation for NSCLC.

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Can stage iii lung cancer ajcc v8 be cured?

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Tumor cell-to-stromal ratio, %CD90, p53 and p16 expression were found to be independent prognostic factors in stage iii lung cancer. Patients with tumor cell-to-stromal ratio>0.1 and %CD90>20% and p53 < 15% showed improved overall survival. Lymph node metastases and age were found to be independent prognostic factors, and in vitro chemotherapy, cisplatin, etoposide, and cisplatin had a positive effect on overall survival.

Unverified Answer

Who should consider clinical trials for stage iii lung cancer ajcc v8?

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Patients with stage iii lung cancer can be treated effectively with an approved medication (pemetrexed) in combination with platinum analogs. This regimen was found to be well tolerated, with excellent responses in approximately 25% of patients.

Unverified Answer

Have there been any new discoveries for treating stage iii lung cancer ajcc v8?

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There are, as of March 2013, still no effective treatments for metastatic [lung cancer](https://www.withpower.com/clinical-trials/lung-cancer), though surgery for stage iii tumors still is a standard treatment in America. Current strategies are only temporarily effective and in some patients have a low survival rate. The problem with lung cancer in general is that only 5% people die of this form of cancer. In some cases, lung cancer is inoperable and has a very poor prognosis. For individuals with this form of lung cancer, there are several promising treatment options including [Targeted therapies.(http://www.nfl.com/nfl/news/2011/10/01/lung-cancer_pilot_program_is_launched_in_texas.

Unverified Answer

How quickly does stage iii lung cancer ajcc v8 spread?

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Stage iii tumors can spread early but are most likely to spread within the first 3 years. However, stage iii cancer will continue to spread to other parts of the body for up to 15 years. Stage iii lung cancer is treated with surgery, radiation therapy, and often multiple rounds of chemotherapy that can cause a number of serious side effects.

Unverified Answer

What does biospecimen collection usually treat?

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This article presents data from four Phase II clinical trials. In a recent study, findings provide the background and rationale necessary for the design of the next Phase III trial in the treatment of MCL in patients with a biologic or symptomatic response after two preceding chemotherapy-based treatment regimens.

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Is biospecimen collection safe for people?

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The overall incidence of serious adverse events associated to the collection of any biospecimen is minimal. We identified the collection of blood as a potential biospecimen with a higher frequency of serious adverse events.

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Is biospecimen collection typically used in combination with any other treatments?

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Patients participating in trials often require collection of biospecimens. The addition of such collection to conventional therapy adds little extra value beyond the already offered by a trial.

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