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Chemotherapy
Chemo + Radiation Therapy + Dostarlimab for Endometrial Cancer
Phase 1
Recruiting
Led By Pamela Soliman, MD
Research Sponsored by M.D. Anderson Cancer Center
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up through study completion; an average of 1 year
Awards & highlights
Study Summary
This trial will study if combination chemo & radiation therapy followed by maintenance therapy can help control endometrial cancer. It'll also assess safety & effects.
Who is the study for?
This trial is for adults over 18 with stage IIIC, node-positive endometrial cancer who've had surgery. They should have good blood counts, kidney and liver function, and no major illnesses that could affect the study. People can't join if they've had certain vaccines recently, uncontrolled diseases, prior treatment with specific antibodies like Dostarlimab or have autoimmune diseases.Check my eligibility
What is being tested?
The trial tests a combination of chemotherapy drugs (Paclitaxel and Carboplatin) with radiation therapy followed by maintenance therapy using Dostarlimab to see if it controls endometrial cancer better and what side effects it might cause.See study design
What are the potential side effects?
Possible side effects include reactions to the infusion of drugs, fatigue, hair loss from chemotherapy, skin changes from radiation therapy. Dostarlimab may also cause immune-related issues such as inflammation in various organs.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ through study completion; an average of 1 year
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~through study completion; an average of 1 year
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Incidence of Adverse Events, Graded According to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) Version (v) 5.0
Trial Design
3Treatment groups
Experimental Treatment
Group I: Immunotherapy after Radiation and ChemoExperimental Treatment4 Interventions
Participants will receive an active treatment for 6 cycles. Participants will be on maintenance for 14 cycles, as long as the disease does not get worse. Follow-up will then occur every 6 months for 5 years (from your enrollment date).
Group II: Adjuvant Therapy During RadiationExperimental Treatment4 Interventions
Participants will receive an active treatment for 6 cycles. Participants will be on maintenance for 14 cycles, as long as the disease does not get worse. Follow-up will then occur every 6 months for 5 years (from your enrollment date).
Group III: Adjuvant Therapy After RadiationExperimental Treatment4 Interventions
Participants will receive an active treatment for 6 cycles. Participants will be on maintenance for 14 cycles, as long as the disease does not get worse. Follow-up will then occur every 6 months for 5 years (from your enrollment date).
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Paclitaxel
2011
Completed Phase 4
~5380
Carboplatin
2014
Completed Phase 3
~6670
Cisplatin
2013
Completed Phase 3
~1940
Dostarlimab
2020
Completed Phase 2
~1000
Find a Location
Who is running the clinical trial?
M.D. Anderson Cancer CenterLead Sponsor
2,974 Previous Clinical Trials
1,789,455 Total Patients Enrolled
21 Trials studying Endometrial Cancer
5,433 Patients Enrolled for Endometrial Cancer
GlaxoSmithKlineIndustry Sponsor
4,755 Previous Clinical Trials
8,070,795 Total Patients Enrolled
6 Trials studying Endometrial Cancer
713 Patients Enrolled for Endometrial Cancer
Pamela Soliman, MDPrincipal InvestigatorM.D. Anderson Cancer Center
4 Previous Clinical Trials
731 Total Patients Enrolled
3 Trials studying Endometrial Cancer
143 Patients Enrolled for Endometrial Cancer
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I am a woman who can still have children and have not been sterilized.I have brain complications from cancer, like swelling or bleeding.I still have side effects from previous cancer treatments.I have an autoimmune disease that could come back or affects my organs.I have an immune system disorder or have been on steroids or other immune-weakening medicines in the last week.My blood clotting levels are within the normal range or properly managed if I'm on blood thinners.My liver is functioning well according to recent tests.I have had lung conditions not caused by infections, except those from radiation.I have been treated with specific immune therapy drugs before.I have not received a live vaccine in the last 30 days.I have had cancer before, but it won't affect this treatment's safety or results.I have stage IIIC endometrial cancer confirmed by surgery and am eligible for additional treatment.I am 18 years old or older.I am fully active or restricted in physically strenuous activity but can do light work.I have a significant liver disease, such as hepatitis or cirrhosis.My kidney function is within the normal range based on recent tests.I joined the trial within 8 weeks and started treatment within 10 weeks of my surgery.I haven't had surgery or investigational therapy within the last 3 to 4 weeks.I do not have any severe ongoing illnesses that could interfere with the study.
Research Study Groups:
This trial has the following groups:- Group 1: Adjuvant Therapy During Radiation
- Group 2: Adjuvant Therapy After Radiation
- Group 3: Immunotherapy after Radiation and Chemo
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- 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
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Are there any known safety risks associated with utilizing adjuvant therapy in combination with radiation treatments?
"Adjuvant Therapy During Radiation has restricted efficacy and safety evidence, thus receiving a rating of 1 on our team's scale."
Answered by AI
Are there any openings for this medical experiment at the present time?
"According to clinicaltrials.gov, this particular trial is no longer recruiting patients as it was initially posted on October 31st 2023 and last updated April 6th 2023. Even so, there are 305 other trials that are presently seeking participants' participation."
Answered by AI
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