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Study Summary
This trial is comparing the effect of immunotherapy with atezolizumab in combination with standard chemotherapy versus standard therapy alone for the treatment of poorly differentiated extrapulmonary small cell neuroendocrine cancer.
- Neuroendocrine Carcinoma
- Extrapulmonary Neuroendocrine Carcinoma
Eligibility Criteria
Inclusion Criteria
You will be eligible if you check “Yes” for the criteria belowTimeline
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Side effects data
From 2012 Phase 3 trial • 256 Patients • NCT01005680Awards & Highlights
Trial Design
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Who is running the clinical trial?
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- You can choose to have your biological samples stored for future research.You should not have symptoms related to cancer that has spread to the brain.You have not received treatment for advanced or metastatic NEC, except for one cycle of a specific kind of chemotherapy.You have a confirmed diagnosis of a specific type of advanced cancer that cannot be removed by surgery or treated with definitive therapy.People with brain lesions who have not yet received treatment must meet specific requirements.You must have a disease that can be seen on a CT scan with IV contrast, and the scan must have been done within the last 28 days before joining the study. All the spots of the disease must be checked and recorded.You do not have a known or suspected condition affecting the covering of the brain and spinal cord.You cannot have certain medical conditions like uncontrolled high calcium levels, weak immune system, autoimmune diseases, lung or heart problems, recent major surgeries, severe infections, active tuberculosis, recent transplants, recent live vaccines, pregnancy, or not using effective birth control.You had a certain type of cancer that was treated with specific therapies at least 6 months ago.You need to have certain blood and liver tests done to make sure you are healthy enough to participate in the study.You need to have a brain scan if your doctor thinks it's necessary, but you don't need it if there are no signs of brain tumors and you're feeling fine.
- Group 1: Arm I (atezolizumab, platinum drug, etoposide)
- Group 2: Arm II (atezolizumab, platinum drug, etoposide, observation)
- Group 3: Arm III (platinum drug, etoposide, observation)
- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
Is this study taking place in multiple states?
"100 patients are being enrolled at this time from locations such as Kaiser Permanente-Ontario, Fred Hutchinson Cancer Research Center, and Kaiser Permanente-San Marcos. There are also 100 other enrolling sites."
What other cancer drugs have been tested with Cisplatin in the past?
"Currently, there are 1655 ongoing trials concerning Cisplatin. Of these, 489 have reached Phase 3 status. Most of the research is based in Shanghai; however, there are 86449 total locations conducting studies related to Cisplatin."
To what extent has Cisplatin been shown to be an effective treatment?
"Cisplatin is a medication that oncologists tend to recommend for advanced head and neck cancer. That being said, it can also be used as a last resort for sarcoma and other conditions where standard therapies have failed."
Are there any open spots available for this research project?
"Yes, this is an ongoing study that originally posted on December 2nd, 2021 and is currently looking for eligible candidates. The listing was last updated on November 4th, 2022."
How many people are being asked to participate in this clinical trial?
"The information available on clinicaltrials.gov supports that this study is still searching for eligible participants. The trial was posted on December 2nd, 2021 and updated November 4th, 2022. There are 100 sites enrolling a total of 189 patients in the study."
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