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Olaparib + Temozolomide for Uterine Leiomyosarcoma
Study Summary
This trial compares using a PARP inhibitor and alkylating agent to usual treatment for advanced uterine leiomyosarcoma after chemotherapy. The combo may be more effective.
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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?
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- I finished my cancer treatment less than 28 days ago.I do not have any ongoing issues with perforations, abscesses, or fistulas.My advanced uLMS has not improved or I couldn't tolerate two previous treatments, including an anthracycline.I can take pills by mouth.I have been diagnosed with MDS or AML.I have previously taken specific medications for my condition.I am willing to have a central venous catheter placed if needed for my treatment.I have not had major surgery in the last 28 days.I have a history of heart problems.My blood pressure is not controlled by medication.I am not taking any strong medications that affect liver enzymes.I am a woman who can have children and my pregnancy test is negative.My cancer has spread and cannot be removed with surgery.I am 18 years old or older.I can take care of myself and perform daily activities.I have recovered from side effects of my previous cancer treatment.My cancer is a type of uterine sarcoma confirmed by tissue analysis.I have not had a recent heart attack or uncontrolled heart rhythm problems.I have previously been treated with trabectedin or pazopanib.My cancer has spread and cannot be removed with surgery, according to my doctor.I do not have any uncontrolled illnesses.
- Group 1: Arm 1 (olaparib, temozolomide)
- Group 2: Arm 2 (trabectedin, pazopanib)
- 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 there still room available for participants in this medical research endeavor?
"According to clinicaltrials.gov, this research is still recruiting volunteers and was first made available on December 9th 2022; the most recent update took place as recently as January 4th 2023."
How many individuals have taken part in this clinical experiment?
"Yes, this experiment is currently accepting participants. The inaugural posting was on December 9th 2022 and the most recent update transpired on January 4th 2023. 70 patients are needed to be enrolled from 1 trial site."
What is the ultimate aim of this medical experiment?
"This scientific exploration, which will be monitored for a period of up to 5 years starting from the date of randomization, has as its primary objective an assessment of overall survival (OS). Secondary goals include assessing duration of response (DOR), disease control rate (DCR) and incidence rate of adverse events. To assess DOR, only patients that have achieved partial or complete responses are considered while DCR is computed by dividing the sum total number evaluable responders with those that achieve stable diseases across arms and comparing them using chi-square tests. Adverse reactions shall be chronicled according to National Cancer Institute's Common Terminology Criteria for"
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