CLINICAL TRIAL

Stereotactic Body Radiation Therapy for Carcinoma

1 Prior Treatment
High Risk
Locally Advanced
Metastatic
Recurrent
Refractory
Recruiting · 18+ · All Sexes · Brighton, MI

Immunotherapy With or Without Radiation Therapy for Metastatic Urothelial Cancer

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About the trial for Carcinoma

Eligible Conditions
Carcinoma · Metastatic Ureter Urothelial Carcinoma · Carcinoma, Transitional Cell · Platinum-Resistant Urothelial Carcinoma

Treatment Groups

This trial involves 2 different treatments. Stereotactic Body Radiation Therapy 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 2 and have already been tested with other people.

Experimental Group 1
Atezolizumab
BIOLOGICAL
+
Questionnaire Administration
OTHER
+
Quality-of-Life Assessment
OTHER
Experimental Group 2
Atezolizumab
BIOLOGICAL
+
Questionnaire Administration
OTHER
+
Quality-of-Life Assessment
OTHER
+
Stereotactic Body Radiation Therapy
RADIATION

About The Treatment

Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Atezolizumab
FDA approved
Stereotactic Body Radiation Therapy
2016
Completed Phase 2
~560

Eligibility

This trial is for patients born any sex aged 18 and older. You must have received 1 prior treatment for Carcinoma or one of the other 3 conditions listed above. There are 10 eligibility criteria to participate in this trial as listed below.

Inclusion & Exclusion Checklist
Mark “yes” if the following statements are true for you:
PRE-REGISTRATION INCLUSION
Histologically confirmed metastatic urothelial carcinoma
You have impaired renal function (creatinine clearance [CrCl] of < 30 mL/min). show original
Eastern Cooperative Oncology Group (ECOG) performance status (PS) of > 2
Grade > 2 peripheral neuropathy
New York Heart Association (NYHA) Heart Failure of > 3
You have received prior platinum-based chemotherapy within 12 months of relapse. show original
You have received prior platinum-based chemotherapy for metastatic disease. show original
Patients must have tissue available for central PD-L1 determination stratification OR agree to undergo a biopsy for additional tissue. show original
Patients must have at least one measurable site > 1 cm in diameter per RECIST 1.1 and a site targetable for radiotherapy. show original
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Odds of Eligibility
Unknown<50%
Be sure to apply to 2-3 other trials, as you have a low likelihood of qualifying for this one.Apply To This Trial
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Approximate Timelines

Please note that timelines for treatment and screening will vary by patient
Screening: ~3 weeks
Treatment: varies
Reporting: Time from randomization until disease progression as assessed by the treating physician using RECIST 1.1 or death due to any cause, assessed up to 3 years
Screening: ~3 weeks
Treatment: Varies
Reporting: Time from randomization until disease progression as assessed by the treating physician using RECIST 1.1 or death due to any cause, assessed up to 3 years
This trial has approximate timelines as follows: 3 weeks for initial screening, variable treatment timelines, and reporting: Time from randomization until disease progression as assessed by the treating physician using RECIST 1.1 or death due to any cause, assessed up to 3 years.
View detailed reporting requirements
Trial Expert
Connect with the researchersHop on a 15 minute call & ask questions about:
- What options you have available- The pros & cons of this trial
- Whether you're likely to qualify- What the enrollment process looks like

Measurement Requirements

This trial is evaluating whether Stereotactic Body Radiation Therapy will improve 5 secondary outcomes in patients with Carcinoma. Measurement will happen over the course of At 1 year.

Rate of treatment discontinuation
AT 1 YEAR
The proportion of patients who discontinue their protocol directed treatment prior to one year from date of study registration will be determined. Patients who stop their protocol directed treatment for any reason prior to one year from study registration will be considered to have discontinued their treatment.
AT 1 YEAR
Overall survival (OS)
TIME FROM RANDOMIZATION UNTIL DEATH DUE TO ANY CAUSE. PATIENTS WHO ARE NOT KNOWN TO BE DEAD AT TIME OF ANALYSIS WILL BE CENSORED AT THE TIME OF THEIR LAST FOLLOW-UP, ASSESSED UP TO 3 YEARS
Stratified Cox models will be used to compare the outcomes between the two treatment groups.
TIME FROM RANDOMIZATION UNTIL DEATH DUE TO ANY CAUSE. PATIENTS WHO ARE NOT KNOWN TO BE DEAD AT TIME OF ANALYSIS WILL BE CENSORED AT THE TIME OF THEIR LAST FOLLOW-UP, ASSESSED UP TO 3 YEARS
Tumor response
UP TO 3 YEARS FROM RANDOMIZATION
Will be assessed by immune modified (i)RECIST.
UP TO 3 YEARS FROM RANDOMIZATION
Incidence of adverse events
UP TO 3 YEARS FROM RANDOMIZATION
Will be assessed by Common Terminology Criteria for Adverse Events version 5.0. Adverse events will be summarized with frequencies and relative frequencies.
UP TO 3 YEARS FROM RANDOMIZATION
Progression-free survival (PFS)
TIME FROM RANDOMIZATION UNTIL DISEASE PROGRESSION AS ASSESSED BY THE TREATING PHYSICIAN USING RECIST 1.1 OR DEATH DUE TO ANY CAUSE, ASSESSED UP TO 3 YEARS
Stratified Cox models will be used to compare the outcomes between the two treatment groups.
TIME FROM RANDOMIZATION UNTIL DISEASE PROGRESSION AS ASSESSED BY THE TREATING PHYSICIAN USING RECIST 1.1 OR DEATH DUE TO ANY CAUSE, ASSESSED UP TO 3 YEARS

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 carcinoma?

Most patients would continue to receive these medications for at least 6 months after their full course of therapy. The most commonly used treatments were chemotherapy, radiotherapy, and surgery. Metastatic carcinoma was treated primarily using chemotherapy and sometimes radiotherapy. Nodal metastases were treated primarily with surgery, occasionally radiotherapy, and rarely chemotherapy. Patients with localized carcinoma were treated primarily with surgery, often with radiotherapy, and seldom chemotherapy. Surgery was also used to treat some patients with liver carcinoma and pancreatic carcinoma. Many patients received no treatment at all; however, this may reflect the fact that many patients did not have known cancerous tumors. These data should help guide future research and clinical practice.

Anonymous Patient Answer

What causes carcinoma?

A large number of disorders and events can cause malignant neoplasms. It is important not only to identify the patient at risk but also to understand the environment in which the disease develops. For example, tobacco use is an environmental risk factor for lung cancer. In particular, smoking increases the risk of developing squamous cell lung carcinoma.\n

Anonymous Patient Answer

What is the average age someone gets carcinoma?

Results from a recent paper revealed that the overall incidence rate of malignancy in Egypt is about 2.6% with a male predominance (1.3%). Carcinoma of the skin was the most common type in both genders followed by [head and neck cancer](https://www.withpower.com/clinical-trials/head-and-neck-cancer). The mean age at diagnosis was 45 years for females and 50 years for males. It is important to identify the risk factors for these cancers, especially squamous cell carcinoma, since they respond well to radiotherapy.

Anonymous Patient Answer

What is the primary cause of carcinoma?

Smoking is the major risk factor for carcinomas in both men and women. The majority of cancers are caused by environmental factors including [sun exposure] and diet. There is a high incidence of cancer in people with diabetes. If people with diabetes know their risk of developing cancer, they should take precautionary measures against it. Diabetes was the most common type of chronic disease in our study.

Anonymous Patient Answer

Does stereotactic body radiation therapy improve quality of life for those with carcinoma?

SBRT is an effective treatment for patients with localized carcinoma of the spine; however, long-term QOL remains poor. Further prospective studies are needed to determine whether this is due to SBRT itself or to chronic pain associated with metastatic disease.

Anonymous Patient Answer

Have there been any new discoveries for treating carcinoma?

The discovery of anti-angiogenesis therapy has opened an avenue for new therapies for treating patients with metastatic carcinomas. It will be interesting to see how this new therapy achieves its therapeutic effects, and whether it will prove efficacious enough to replace conventional chemotherapy.

Anonymous Patient Answer

What is the survival rate for carcinoma?

Carcinoma has a poor prognosis. The 5-year survival rate is 16%. Patients who are older than 70 years have a lower survival rate compared to younger patients. Patients with early stage disease (stage I or II) have an improved survival compared to late stage disease (stage III or IV).

Anonymous Patient Answer

What are the latest developments in stereotactic body radiation therapy for therapeutic use?

SBRT is an important tool for treating patients with advanced tumors because it can target high dose radiation coverage to tumor sites while sparing normal tissues. SBRT is also useful for treating tumors located near critical structures. For example, SBRT is being studied to treat breast cancer in conjunction with chemotherapy to prevent or reduce the development of late complications. More research is needed to further explore the role of SBRT as an effective treatment modality.

Anonymous Patient Answer

Does carcinoma run in families?

A family history of cancer is associated with an increased risk of developing carcinoma. However, the risk of developing carcinoma is not higher than that of the general population for those who have no family history of cancer. Other factors such as genetic susceptibility, environmental exposures, and behavior cannot be ruled out.

Anonymous Patient Answer

What is the latest research for carcinoma?

There have been few recent publications about carcinoma. In this article, we review the latest research and provide key insights into the pathogenesis of carcinoma. It is important for physicians and patients to keep track of the latest developments in cancer therapy.

Anonymous Patient Answer

How does stereotactic body radiation therapy work?

SBRT is an effective method for treating NSCLC; however, this treatment may have significant side effects. Clinicians need to be aware of these potential complications so that they can counsel patients appropriately about their treatment options. In addition, when considering SBRT as a primary treatment option for patients with early stage NSCLC, clinicians must take into account the risks and benefits of any systemic therapies administered in conjunction with SBRT.

Anonymous Patient Answer
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