Quality-of-Life Assessment for Small Cell Lung Carcinoma

Phase-Based Estimates
1
Effectiveness
2
Safety
Diagnostic and Treatment Center, Weston, WI
Small Cell Lung Carcinoma+15 More
Quality-of-Life Assessment - Other
Eligibility
18+
All Sexes
Eligible conditions
Small Cell Lung Carcinoma

Study Summary

This study is evaluating whether a combination of chemotherapy and radiation therapy with or without an immunotherapy drug may help treat limited stage small cell lung cancer.

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Eligible Conditions

  • Small Cell Lung Carcinoma
  • Lung Cancer
  • Carcinoma, Small Cell
  • Limited Stage Small Cell Lung Carcinoma
  • Stage IB Lung Cancer AJCC v8
  • Stage IIIC Lung Cancer AJCC v8
  • Stage IIIA Lung Cancer AJCC v8
  • Stage IA2 Lung Cancer AJCC v8
  • Stage IA1 Lung Cancer AJCC v8
  • Stage IIB Lung Cancer AJCC v8
  • Lung Neoplasms
  • Stage III Lung Cancer AJCC v8
  • Stage I Lung Cancer AJCC v8
  • Stage IIA Lung Cancer AJCC v8
  • Stage II Lung Cancer AJCC v8
  • Stage IA3 Lung Cancer AJCC v8
  • Stage IIIB Lung Cancer AJCC v8

Treatment Effectiveness

Effectiveness Estimate

1 of 3

Study Objectives

This trial is evaluating whether Quality-of-Life Assessment will improve 1 primary outcome, 9 secondary outcomes, and 1 other outcome in patients with Small Cell Lung Carcinoma. Measurement will happen over the course of Up to 15 months after the end of the 4th cycle of chemotherapy.

Year 5
Distant metastases-free survival (DMFS)
Year 5
Progression free survival (PFS)
Year 5
Overall survival (OS)
Month 15
Patient-reported symptomatic toxicities
Month 15
Quality of life (QoL)
Up to 2 years
Level of fatigue
Quality-adjusted survival
Up to 5 years
Blood based tumor mutational burden (bTMB) and tissue-based tumor mutational burden (tTMB)
Incidence of adverse events
Local control
Objective response rate (ORR)

Trial Safety

Safety Estimate

2 of 3
This is better than 68% of similar trials

Trial Design

2 Treatment Groups

Arm II (etoposide, cisplatin, carboplatin, radiation therapy)
Arm I (etoposide, cisplatin, carboplatin, radiation therapy)

This trial requires 506 total participants across 2 different treatment groups

This trial involves 2 different treatments. Quality-of-Life 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 2 & 3 and have had some early promising results.

Arm I (etoposide, cisplatin, carboplatin, radiation therapy)Patients receive etoposide IV on days 1-3 and cisplatin IV or carboplatin IV on day 1. Cycles repeat every 21 days for 3 cycles in the absence of disease progression or unacceptable toxicity. Patients also undergo 3D-CRT or IMRT BID for approximately 3 weeks or QD for approximately 6-7 weeks in the absence of disease progression or unacceptable toxicity.
Arm II (etoposide, cisplatin, carboplatin, radiation therapy)Patients receive treatment as in Arm I. Patients also receive atezolizumab IV over 30-60 minutes on day 1 or 2 of each chemotherapy cycle. Cycles repeat every 3 weeks for 17 cycles (1 year) in the absence of disease progression or unacceptable toxicity.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Platinum
Not yet FDA approved
Etoposide
FDA approved
Carboplatin
FDA approved
3-Dimensional Conformal Radiation Therapy
2005
Completed Phase 3
~6730
Intensity-Modulated Radiation Therapy
2009
Completed Phase 3
~1230

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: up to 5 years
This trial has the following approximate timeline: 3 weeks for initial screening, variable treatment timelines, and roughly up to 5 years for reporting.

Closest Location

Diagnostic and Treatment Center - Weston, WI

Eligibility Criteria

This trial is for patients born any sex aged 18 and older. There are 10 eligibility criteria to participate in this trial as listed below.

Mark “yes” if the following statements are true for you:
The person has a limited stage small cell lung cancer that has been proven through pathology (an examination of tissue under a microscope), within 60 days prior to registration. show original
Patients who have received at least one cycle of platinum-based chemotherapy prior to study enrollment are eligible for this study show original
A PET/CT scan is done within 60 days of registration to help stage the cancer. show original
A CT chest and CT abdomen with IV contrast should be done within 60 days of registration, unless the patient's kidney function prevents it show original
on study The patient must have an Eastern Cooperative Oncology Group (ECOG) performance status of 0-2 within 30 days prior to registration on study. show original
The patient must have an absolute neutrophil count (ANC) of at least 1,500/cells/mm^3 before starting the pre-registration cycle. show original
, and measurable disease must be present on or after the first day of the required platinum/etoposide cycle The patient must have had measurable cancer before the first day of their required cycle of platinum/etoposide chemotherapy, and their cancer must be measurable after the first day of that cycle. show original
This means that you need to have a history and physical examination done within 30 days of your registration. show original
Note: If contrast allergy exists, premedication per institutional guidelines should be performed prior to obtaining CT with contrast. The only exception to this is a documented life-threatening allergy
An MRI scan of the brain with contrast or a CT scan of the brain with contrast within 30 days prior to registration is preferred, but if there is a contraindication with MRI with contrast, a CT scan with contrast is allowable. show original

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 common treatments for small cell lung carcinoma?

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Nearly every patient suffers from pain related to SCLC and/or pleural effusion. SCLC is associated with a significantly worse quality of life than most other cancers.

Unverified Answer

Can small cell lung carcinoma be cured?

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SCLC has both an excellent and dismal prognosis regardless of treatment intensity. However, in patients with limited disease who respond to chemotherapy, the ultimate cure rate is up to 85 %. It is imperative that patients with an underlying cancer are informed of this reality, and that the potential benefits of innovative therapies are realized.

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What are the signs of small cell lung carcinoma?

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CT and PET images are helpful for distinguishing pulmonary nodules from other radiographic patterns. Lymph node lesions in patients with localized small cell lung carcinoma can be diagnosed on CT and PET images.

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What is small cell lung carcinoma?

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SCLC is a very malignant cancer that mainly affects older adults, typically those in their sixties and 70s. It primarily arises in the lungs, but also in many other organs including the stomach (gastric SCLC), liver, bone marrow, brain and prostate gland(prostate SCLC). Small cell carcinoma accounts for about 3% of lung cancer cases worldwide. This aggressive cancer generally has a mean survival of five to 20 months after presentation, but with prolonged survival in rare cases. The prognosis for this disease is improving as more precise methods of diagnosis are refined, treatments become more established such as combination chemotherapy.

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What causes small cell lung carcinoma?

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Given its high prevalence and mortality rate, SCLC is an important public health concern on a world on a local basis. The increased incidence of SCLC in recent years is mainly attributed to cigarette smoking and secondhand smoke. Thus, further studies are warranted to develop an effective preventive strategy for SCLC.

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How many people get small cell lung carcinoma a year in the United States?

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In the U.S., SCLC occurs in about 2 cases per 100,000 new adults per year. The incidence of SCLC decreases as age increases. The incidence should be interpreted with caution as age-standardized incidence rate is higher than age-adjusted incidence rate.

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Who should consider clinical trials for small cell lung carcinoma?

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Only the following two considerations seem relevant for evaluating a possible clinical trial for patients with SCLC: a) whether they can receive, appreciate and tolerate the study; b) how much burden of the clinical trial treatment can be put on them; furthermore, only for patients whose disease is considered to be manageable in terms of current standards should clinical trials be accepted.

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Is quality-of-life assessment safe for people?

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Quality-of-life assessment provides an important aspect to clinical evaluation with [palliative care]. Results from a recent clinical trial, it was demonstrated that patients and their families benefited from an investigation of their global quality of life with standardized and validated assessment tools.

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What are the chances of developing small cell lung carcinoma?

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[Most of patients will develop [small cell lung cancer](https://www.withpower.com/clinical-trials/small-cell-lung-cancer) (SCLC) in their lifetime with the average lifespan being around 2 years] while the average age for developing small cell lung carcinoma is around 61 years. However, not all patient will develop SCLC in their lifetime; so the chances of developing small cell lung carcinoma depends on many factors, such as the chances of developing SCLC with the overall lifetime and the chance of developing SCLC within their lifetime.\n\n[The lifetime chance of developing small cell lung carcinoma is 0.1% if one lives to age of 90, 0% if one lives to age of 50 and 80% if they live until age of 40.

Unverified Answer

What are the common side effects of quality-of-life assessment?

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Assessment of QOL should not be limited to health-related QOL alone. The impact of QOL on physical function should be evaluated along with the QOL measures which may improve a QOL score. The importance of QOL assessment in lung cancer patients is discussed.

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What is the primary cause of small cell lung carcinoma?

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Patients with SCLC were more likely to have a history of tobacco smoking than control subjects. This association is plausible and confirms the hypothesis that exposure to carcinogens increases the risk of an SCLC diagnosis. More research is warranted to determine the extent to which cigarette smoke directly causes or contributes to the development of lung carcinoma.

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What is quality-of-life assessment?

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When assessing HRQoL in cancer patients, it is important to perform HRQoL assessment using the most appropriate instrument (e.g., the EORTC QLQ C30). Results from a recent paper of HRQoL assessment may help us to achieve goals in patients with cancer-related diseases.

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