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Chemotherapy +/− Ganitumab for Ewing Sarcoma
Study Summary
This trial is testing how well combination chemotherapy works with or without the drug ganitumab in treating patients with newly diagnosed Ewing sarcoma.
Eligibility Criteria
Inclusion Criteria
You may 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 2019 Phase 2 trial • 32 Patients • NCT01573702Trial Design
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Who is running the clinical trial?
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- My cancer started in the soft tissues within the brain's protective layers.I have had chemotherapy or radiation therapy before.My cancer has spread to distant lymph nodes.My lung nodules are considered as spread cancer.I have enough tumor tissue available for testing.My baby's kidney function is normal, with creatinine ≤0.4 mg/dL.My liver enzyme levels are within the normal range, except I have liver cancer.My cancer has spread to my bones.I am sexually active and not using effective birth control.I have been newly diagnosed with Ewing sarcoma or PNET with cancer spread to lungs, bones, or other areas.My lung nodules are considered as spread cancer based on certain criteria.My cancer has spread to my bone marrow, meeting specific conditions.I have enough tumor tissue for testing.My bilirubin levels are within the normal range for my age.I have been diagnosed with Ewing sarcoma or PNET with cancer spread to lung, bone, or other areas.My cancer has spread only to the lymph nodes near the original tumor.I am a woman who can have children and do not have a negative pregnancy test result.My blood sugar levels are within the normal range for my age.My kidney function is good based on recent tests.I am on long-term steroid medication.I have only had a biopsy of my tumor, no surgery to remove it.My kidney function is normal or near normal.
- Group 1: Regimen A (VDC/IE)
- Group 2: Regimen B (VDC/IE + ganitumab)
- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
- Pivotal Trial - The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
- 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
Has this sort of clinical trial been attempted before?
"Stereotactic Radiosurgery has been researched for over two decades. The first clinical trial occurred in 1997 and was sponsored by Alfacell. The study involved 300 participants. After the first trial, Stereotactic Radiosurgery received its Phase 3 drug approval. As of now, there are 1261 active studies being conducted for Stereotactic Radiosurgery across 2609 cities and 78 countries."
What condition is Stereotactic Radiosurgery typically used to treat?
"Cancers such as Merkel cell cancer, leukemia, and prostate cancer can be treated using Stereotactic Radiosurgery."
What are some similar cases in which Stereotactic Radiosurgery has been used?
"There are a total of 1261 clinical trials investigating Stereotactic Radiosurgery. Of these, 269 are currently ongoing and in Phase 3. The many studies for Stereotactic Radiosurgery are based in Philadelphia, Pennsylvania, but there are 46545 locations running trials for this treatment."
How many people are helping test this new medical treatment?
"This study is not presently looking for more participants. According to the latest update on September 23rd, 2022, the study is not currently in need of subjects. If you are looking for other trials, 3433 studies related to bone and 1261 studies related to Stereotactic Radiosurgery are actively recruiting."
What governing body has blessed the use of Stereotactic Radiosurgery?
"There is some data supporting Stereotactic Radiosurgery's efficacy, and as this is a Phase 3 trial, there is also evidence from multiple rounds of testing that confirm its safety--so we've given it a score of 3."
What do researchers expect to find at the conclusion of this study?
"The primary outcome of this trial, which will be evaluated over approximately 5 years after enrollment is Event-free survival (EFS). Secondary outcomes include Sinusoidal obstructive disease (SOS) associated with the addition of ganitumab to VDC/IE which is defined as A phase where a patient experiences any SOS will be considered a phase with an SOS toxicity-event. The effect of possible correlations between analytic units that arises because some analytic units are contributed by the same individual will be explored. A random effects binomial model where a Normally distributed random effect with 0 mean and unknown variance chi-squared is contributed by each"
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