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Combination Chemotherapy for Rhabdomyosarcoma
Study Summary
This trial is testing a new cancer treatment for patients with high risk rhabdomyosarcoma. The treatment is a combination of 4 drugs, and the trial will test if it is more effective than the current standard of care.
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.Trial Design
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Who is running the clinical trial?
Media Library
- My cancer in the bone marrow is confirmed by specific staining, not just advanced tests.This is not a complete criterion. Can you please provide more information about what "ARMS" refers to in this context?My cancer is Embryonal Rhabdomyosarcoma (ERMS).I haven't taken strong medication affecting liver enzymes in the last week.I have a specific type of muscle cancer that is not adult-type pleomorphic.My kidney function is normal or near normal.I am 50 years old or younger.My FOXO1 fusion status will be checked by the 4th week of treatment.My cancer has spread to my brain or spinal cord.I have not had chemotherapy or radiation for RMS before joining.My bilirubin levels are within the normal range for my age.I do not have any untreated infections.My RMS is a second cancer, previously treated with chemo or radiation.I have a newly diagnosed type of RMS cancer, not the adult-type pleomorphic.My cancer has spread to my bone marrow, confirmed by specific staining tests.I am 10 years or older with stage 4 cancer.
- Group 1: Arm A (VAC, VINO-CPO)
- Group 2: Arm B (vinorelbine, VAC, VINO-CPO)
- 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
How many study participants are needed for this clinical trial?
"The clinicaltrials.gov website confirms that this trial is open and recruiting patients. The listing indicates that the trial was first posted on September 13th, 2021 and was last updated on August 3rd, 2022. The trial is looking for 8 patients total, with 6 different locations hosting the trial."
Could you share how many health care facilities are hosting this research project?
"This trial has 6 recruiting sites, which are Rady Children's Hospital - San Diego in San Diego, UT Southwestern/Simmons Cancer Center-Dallas in Dallas, and NYP/Columbia University Medical Center/Herbert Irving Comprehensive Cancer Center in New york. There are also 6 other locations."
Are there any more open vacancies for people who want to participate in this trial?
"This trial, which is currently seeking participants, was originally posted on September 13th 2021. The listing on clinicaltrials.gov was most recently updated on August 3rd, 2022."
What is the government's official stance on Radiation Therapy?
"Radiation therapy has a score of 3 on our safety scale at Power, because it is a phase 3 trial. This means that there is some data supporting its efficacy, as well as multiple rounds of data supporting its safety."
What is the general efficacy of Radiation Therapy according to other research?
"Currently, 967 clinical trials related to radiation therapy are underway. Of those, 203 are in Phase 3. While the majority of trials for radiation therapy are taking place in Philadelphia, Pennsylvania, there are a total of 35,190 locations running trials for this treatment."
What afflictions are most often healed by Radiation Therapy?
"Radiation Therapy is often the go-to treatment for lymphocytic lymphomas. However, it can also be used to effectively target other conditions, like gestational trophoblastic disease, neoplasms, and chronic granulocytic leukemias."
Who else is applying?
How old are they?
What site did they apply to?
What portion of applicants met pre-screening criteria?
What state do they live in?
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